HomebasedpulmonaryrehabCOPD by Asociación Latinoamericana de Tórax ALAT

Home-based pulmonary rehabilitation in chronic obstructive pulmonary disease patients Danielle S.R. Vieiraa,b, Francois Maltaisc and Jean Bourbeaua a Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre, Montreal, Quebec, Canada, bDepartment of Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Minas Gerais, Brazil and c Centre de Recherche, Hoˆpital Laval, Institut Universitaire de Cardiologie et de Pneumologie de l’Universite´ Laval, Quebec, Canada

Correspondence to Jean Bourbeau, MD, Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, 3650 St-Urbain Street, K 1.32 Montreal, QC H2X 2P4, Canada Tel: +1 514 934 1934x32185; fax: +1 514 843 2083; e-mail: jean.bourbeau@mcgill.ca Current Opinion in Pulmonary Medicine 2010, 16:134–143

Purpose of review Home-based pulmonary rehabilitation programs have been proposed as an alternative to hospital-based programs for patients with chronic obstructive pulmonary disease (COPD). We undertook a systematic review of randomized studies on home-based pulmonary rehabilitation in patients with COPD which report health-related quality of life and/or exercise capacity, in order to assess the benefits of this intervention. Main findings From 888 identified references, 12 met the inclusion criteria. Overall, the methodological quality of the studies was average to poor. Eight studies compared home-based rehabilitation to standard care, three compared home-based rehabilitation to hospital-based programs and one included both comparisons. Most of the studies showed improvement in health-related quality of life (statistically and clinically significant) and exercise capacity following home-based rehabilitation as compared with standard care (no pulmonary rehabilitation). Studies that compared home-based pulmonary rehabilitation with hospital-based outpatient programs have not been able to show statistically and clinically significant differences for health-related quality of life and exercise capacity. Adverse events, usually mild, were reported in only two studies. Summary Self-monitored, home-based rehabilitation may be an alternative to outpatient rehabilitation. These findings can help expand the recognition, application and accessibility of pulmonary rehabilitation for patients with COPD. Keywords chronic obstructive pulmonary disease, home-based rehabilitation, pulmonary rehabilitation, systematic review Curr Opin Pulm Med 16:134–143 ß 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins 1070-5287

Introduction Rehabilitation programs for patients with chronic obstructive pulmonary disease (COPD) are well established as a means of enhancing standard therapy in order to control and alleviate symptoms, optimize functional capacity and improve health-related quality of life (HRQL) [1,2]. Most of the pulmonary rehabilitation programs have been conducted in a hospital setting or healthcare facility under direct supervision of a healthcare professional. Poor access to pulmonary rehabilitation is an impediment to the widespread use of this effective intervention in most of the countries where it has been studied [3–5]. Home-based pulmonary rehabilitation programs have been proposed as an alternative to hospital-based programs. With minimal supervision, consequently, fewer resources would be needed and more patients could be enrolled. However, the questions 1070-5287 ß 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins

remain whether home-based rehabilitation programs are effective and well tolerated. The primary objective of this study is to undertake a systematic review of randomized studies on home-based pulmonary rehabilitation in patients with COPD which report exercise capacity, in order to assess the benefits of this intervention. As secondary objectives, we assessed the risks of home-based pulmonary rehabilitation and whether findings are consistent across populations of COPD, supervision and exercise training program variation.

Methods This section will describe the criteria of inclusion for considering studies in this review, the search methods, the trial selection, the data extraction, the assessment of methodological quality and the data synthesis. DOI:10.1097/MCP.0b013e32833642f2

Rehabilitation in pulmonary disease patients Vieira et al. 135

Criteria of inclusion for considering studies in this review

With respect to the type of studies, only published randomized clinical trials comparing home-based rehabilitation to a comparator, standard care (i.e. no pulmonary rehabilitation) or pulmonary rehabilitation of any setting other than a home-based program that fulfilled the selection criteria were considered for inclusion in this systematic review.

editorials, and studies that assessed other disease populations or aspects not related to the objective of this systematic review, such as self-management education, respiratory muscle training and so on, were excluded. Any case of an article for which inclusion was questioned was resolved through discussion with a second reviewer (J.B.). Justification for excluding studies from the review was documented. Data extraction

With respect to the type of participants, studies included patients with COPD (any definition) and at least 40 years old. With respect to the type of interventions, all studies had at least one treatment arm that involves a home-based rehabilitation program with lower-limb endurance exercise training and minimum duration of at least 4 weeks or 12 sessions. The same criteria were considered for the rehabilitation programs carried out in other settings. Studies in which the home-based training was aimed at maintaining the effects of inpatient or outpatient rehabilitation programs or in which the training was not completed only at home, requiring regular visits to a rehabilitation center, were excluded. With respect to type of outcome measures, the following were considered as outcomes: HRQL, exercise capacity assessed by field tests (6-min walking test, shuttle walking test) or laboratory tests (incremental exercise test, endurance test, step test), symptom (dyspnea), muscle strength and exacerbation rate and hospital admissions. Search methods for identification of studies

The following databases were searched: MEDLINE (1980 to October 2009), EMBASE (1980 to October 2009) and Cochrane Central Register of Controlled Trials (CENTRAL). The Cochrane Database of Systematic Reviews was also searched to find out whether systematic reviews on this subject had been published. The search strategies for MEDLINE and EMBASE were developed considering the keywords specifically for each database, as shown in annex 1 (Annex 1 is available directly from the corresponding author). The searches were done via OVID. Language was limited to English, French and Spanish. Furthermore, reference list of review articles and of all the included studies were hand searched in order to find other potentially eligible studies. Moreover, the Internet was searched via general search engines such as Google for relevant studies.

One researcher (D.V.) extracted study-specific data and a second researcher (J.B.) double-checked this information. Any disagreements were resolved by consensus. For each study, the following information was entered into a customized database: bibliographic details (ID, first authorâ&#x20AC;&#x2122;s name and year), study setting and design, ethics approval, aim of the study, duration of follow-up, sampling and allocation, description of the participants included in the study (predefined inclusion and exclusion criteria), number of participants recruited/included in the study, classification of COPD severity, and demographic details [age, sex, diagnosis and forced expiratory volume in 1 s (FEV1), smoking status/history, co-morbidities], details and characteristics of the interventions and control treatments, sample size calculation, outcomes, psychometric properties of the instruments, data analysis, number of patients with outcome data per group, reasons for withdrawals and dropouts per group, adverse event rates and results. Assessment of methodological quality

The PEDro scale was used for quality assessment [6,7]. When articles had not been assessed for quality on the PeDro database, quality assessment was carried out by two reviewers and any disagreement was resolved by consensus. The results of the quality assessment were used for descriptive purposes to present an evaluation of the overall quality of the included studies. Data synthesis

A narrative synthesis method was employed, that is, the use of narrative text and tables to summarize data. A detailed summary table and commentary on methodological quality were also included. Tables were used to present the results with respect to the primary outcome, that is, exercise capacity. Results of the studies including within-group differences from baseline and betweengroup differences were presented when provided in the manuscript. When available, other outcomes and adverse events data were also summarized.

Trials selection

One reviewer (D.V.) inspected the abstract of each reference identified by the search and determined the potential relevance of each article, using the criteria of inclusion. Review papers, study protocols, commentaries,

Results The search strategy initially produced a total of 888 references of which 288 papers were identified as duplicates. The review yielded 73 potentially relevant articles

136 Obstructive, occupational and environmental diseases

that possibly fulfilled inclusion criteria. Among these, 12 met inclusion criteria and were included in the review. Figure 1 summarizes the identification and the selection process for the studies included in the systematic review, the number of studies included and excluded, as well as the reasons for exclusion. Description of the studies

The characteristics of the studies are described in Table 1. The protocols of all studies were similar, that is, parallel controlled randomized clinical trial. Study duration was relatively short ( 6 months) in most of the studies except for three ( 1 year) [8,9 ,10]. Studies enrolled COPD patients who were 60 years old or more, presenting with severe disease (on average GOLD stage 3 and 4) and clinically stable. Sample size was small in most of the studies (20–60 patients in total) except for one (252 patients in total) [9 ]. Of the 12 included studies, three compared home-based rehabilitation with a hospital-based program [9 ,11 ,12], eight compared home-based rehabilitation with standard care [8,13–19] and one included both comparisons [10]. Standard care was usually defined as no additional treatment except for education and lifestyle change advice.

Home-based training programs were mostly of 8-week duration or more, three sessions per week or more and at least 30 min per session. The exercise programs included endurance training, that is, walking, cycling and/or climbing stairs. Training intensity for the homebased rehabilitation program was specified for only six studies [8,9 ,10,11 ,12,18]. Patients were instructed to exercise at 60% or more of peak work rate [9 ,10], 90% of velocity in 6-min walking test [8], 3–4 km/h marked with pedometer [11 ,12] including 10 min to elicit moderate dyspnea [12] and 5–15 min 30 W [18]. For the three studies with hospital-based rehabilitation as the comparator, training intensity aimed at reaching 60–80% peak work rate. Outcomes included health-related quality of life [Chronic Respiratory Questionnaire (CRQ) or Saint George’s Respiratory Questionnaire (SGRQ) mostly], exercise capacity by the 4-min, 6-min or 12-min walk test, the shuttle walk test, the cardiopulmonary exercise test (incremental and at constant work rate), dyspnea by the MRC or the Borg scale during exercise, muscle strength, and exacerbations or hospital admissions in only a few studies. Muscle strength was assessed by the method proposed by Kendall (grades 0–5) [8] or by the capacity of lifting 2.5-kg

Figure 1 Flow chart of the identification and selection of randomized clinical trials assessing home-based pulmonary rehabilitation in chronic obstructive pulmonary disease

888 potential references identified from initial search - EMBASE: 408 - MEDLINE: 360 - CENTRAL: 110 - GOOGLE: 2 new references - Hand search: 8

Excluded 815 references

73 potentially relevant studies retrieved

12 studies included in the systematic review

Reasons for exclusion: - Duplicates (n = 288) - Review papers, study protocols, commentaries and editorials (n = 199) - Language (n = 2) - Other disease population (n = 43) - Other aspects assessed (out-patient rehabilitation, oxygen therapy, noninvasive ventilation, etc) (n = 240) - Only title available (n = 43)

Reasons for exclusion: - Not a RCT (n = 28) - Rehabilitation program did not includ endurance training (n = 12) - Home rehabilitation as maintenance after in- or outpatient program (n = 13) - Home rehabilitation not completed only at home (n = 5) - Rehabilitation program delivered by video (n = 1) - COPD definition was not clear (n = 1) - Full text article inaccessible (n = 1)

COPD, chronic obstructive pulmonary disease; RCT, randomized controlled trial.

HBG: 68(7), CG: 30(8)

HBG: 66(6), OBG: 63(7)

HBG: 66(9), OBG: 66(9)

HBG: 66(6), CG: 68(7)

HBG: 78(8), CG: 76(8)

HBG: 67(10), CG: 38(12)

HBG: 28(7), 59 (4). Mean CG: 26(7) age for each group not reported

Maltais et al. [9 ]b

Resqueti et al. [18]

Boxall et al. [13]

Murphy et al. [17]

Singh et al. [19]

HBG: 40(16), CG: 38(15)

HBG: 27(9), CG: 30(8)

HBG: 46(13), OBG: 43(13)

HBG: 39(8), OBG: 37(7)

252

Gu¨ell et al. [11 ]

HBG: 33(10), CG: 38(12)

HBG: 66(8), CG: 70(5)

Comparison intervention

Co-intervention

First two weeks: learning sessions in hospital. Third to ninth week: 5/week. Endurance: interval training on an ergocycle (5–15 min at 30 W); others: UST and RMT 12 weeks. Patients advised to exercise daily. Endurance: walking guided by SpO2 during the 6MWT and dyspnea 6 weeks, 12 supervised exercise sessions (2/week) during 30–40 min, unsupervised sessions in the other days ( 15 min). Endurance: stepping up and down a stair and sitting to standing from a chair. Other: UST 4 weeks, 2/day. Endurance: walking as possible with a submaximal speed

6 weeks for all outcomes, except for exacerbation rate (6 months)

4 weeks

HBG: patients visited weekly for the first 6 weeks, and then fortnightly visits until the end of the program HBG: visited at home, 2/week for 6 consecutive weeks

Patients were supervised weekly

None

HBG: breathing exercises, removal of secretions and energy conservation

CG: patients received standard medical treatment without any form of rehabilitation exercises or lifestyle change advice

CG: patients were asked to continue their activities as usual

12 weeks, except for average length of stay (6 months)

6 months

HBG: weekly phone calls

Education sessions for the HBG (11 sessions)

On the first week, both groups received 1 h of education and 30 min of respiratory physiotherapy

1 year

6 months

1 year

HRQL (CRQ); 6MWT. AE not reported

Patients in both groups were instructed to continue exercising at home after the 12 weeks. Phone calls every 2 months Patients instructed to continue exercising at home after 9 weeks. Monthly phone calls

At the end of the ninth week, patients were instructed to continue the same training routine

Comment

(continued overleaf )

HRQL (SGRQ); 6MWT; dyspnea (Borg scale), hospital admission; length of stay. At 12 weeks and 6 months. AE reported HRQL (SGRQ and EuroQol EQ-5D); exacerbation rate; dyspnea (Borg scale and MRC); incremental SWT; 3-min step test; isometric muscle strength. AE reported

Primary: HRQL – dyspnea domain of CRQ at 1 year. Secondary (at 3 months and 1 year): other CRQ domains; SGRQ; 6MWT; endurance time (CPET). AE reported HRQL (CRQ); 3MWT. Dyspnea (MRC); outcomes assessed at 9 weeks and 6 months. AE not reported

HRQL (CRQ); 6MWT; muscle strength of UL. Outcomes assessed at 9 weeks and 6 months. AE not reported

HRQL (SGRQ); 6MWT; dyspnea (Borg scale); muscle strength of UL and LL; AE not reported

Duration of follow-up Outcome

HBG: program initiated by an exercise specialist followed by weekly phone calls. OBG: supervised by an exercise specialist during all the program

HBG: during the first week, a physical therapist taught the home-program to the patients

HBG: patient visited at home twice monthly (first 2 months) and then monthly visits

Program supervision

CG: patients did not receive any treatment in addition to usual medical care

CG: patients were advised to perform respiratory exercises and walk at home without any supervision

Both groups received 1 year, 5/week (at least). CG: patients in this group three respiratory received only respiratory Endurance: walking for education sessions education sessions 30 min at 90% of velocity of 6MWT (target intensity). Other: respiratory reeducation; RMT; and UST On the first week, OBG: first week: hospital First week: hospital both groups received sessions. Second to third sessions. Second two and four sessions week, 3/week: endurance – to third week: of respiratory cycling at 60% of peak endurance – walking physiotherapy WR for 30 min. Other: daily (4 km/h (respiratory exercises) RMT and UST pedometer) for 45 min þ stepping up and down a stair (5 min). Other: RMT and UST Education for 4 weeks OBG: 8 weeks, 3/week. 8 weeks, 3/week. in both groups Endurance: cycling at Endurance: cycling 80% of peak WR for at 60% of peak WR 25–30 min and ST for 40 min. Other: identical to the homeST (muscles not based group specified)

Sample Home-based exercise sizea (total) program

Ferna´ndez et al. [8]

FEV1 (%)

Age (years)

Study

COPD patient characteristics

Table 1 Description of the studies

Rehabilitation in pulmonary disease patients Vieira et al. 137

HBG: 66(5), OBG: 63(4)

HBG: 45(7), HBG: 60(8), OBG: 40(20), OBG: 61(5), CG: 43(9) CG: 63(5)

Puente-Maestu et al. [12]

Strijbos et al. [10]

Predicted values not provided

McGavin et al. [16]

12 weeks, 6/week. Endurance: walking for 1 h (walking speed indicated by an audible signal); initial training, 70% of the maximum speed of SWT 8 weeks, 4/week. Endurance: walking 3–4 km (pedometer) in 1 h. Patients asked to walk at a pace to elicit moderate dyspnea 10 min into 1 h 24 supervised sessions of 30 min in 12 weeks. Patients instructed to exercise individually at least 30 min on the exercise days and at least 15 min on the others. Endurance: walking and stair climbing. Cycling at 70% of peak WR 18 weeks, 5/week (at least). Endurance training: walking or stair stepping. Patients exercised to their symptomlimited level. Others: ST and mobility 3 months, 5/week. Endurance: stair climbing. Most disabled, started with two steps up and down for 2 min. Less disabled, five steps for 5 min

Sample Home-based exercise sizea (total) program Program supervision

Patients of the Dyspnea (Borg scale); HBG and OBG exercise capacity instructed to (CPET on a bicycle, exercise daily at 4-min walking distance. home after the All outcomes assessed 12-week program at 6, 12, and 18 months. AE not reported

HRQL (CRQ dyspnea) and multistage step test at 6, 12, and 18 weeks; exercise capacity (CPET on a bicycle at 18 weeks). AE not reported CPET on a bicycle and 12MWT. AE not reported

18 months

18 weeks

3 months

None

Both groups were advised not to smoke

CG: instructed not to change their customary lifestyle and activity level

CG: no exercise instruction or outpatient check

HBG: seen at a clinic after 2 weeks and monthly to assess the exercise program and make changes as needed

HBG: contacted or visited this group every 2 weeks to monitor and progress exercises. CG: visited every 3 weeks

8 weeks

HBG and OBG: education, HBG and OBG: In both groups, the rehabilitation breathing and relaxation program was carried exercises and bronchial out by health staff and hygiene general practitioner

HBG: 1/week visits to the clinic, pedometer checked and encouraged to exercise; OBG: sessions supervised

CG: standard medical care. OBG: supervised sessions – 12 weeks, 2 weeks, 1–h/session. Patients instructed to exercise daily. Endurance training similar to the HBG

Comment

None

HRQL (CRQ); dyspnea (BDI/TDI, MRC, Borg); exercise capacity (CPET, incremental SWT, walking test at 70% maximum speed SWT). AE not reported HRQL (CRQ); dyspnea (Borg scale); exercise capacity (CPET and constant work rate on a treadmill). AE not reported

Duration of follow-up Outcome

12 weeks Patients in the HBG went to the hospital every 2 weeks for supervision of their clinical status and exercise-training compliance

OBG, 8 weeks, 4/week. Endurance: walking on a treadmill for 1 h at 3 km/h and slope 25% of D (peak VO2)

Co-intervention None

CG: standard medical treatment and visits to the hospital every 2 weeks for a clinical checkup

Comparison intervention

6MWT, 6-min walking test; AE, adverse events; BDI, basal dyspnea index; CG, control group; COPD, chronic obstructive pulmonary disease; CPET, cardiopulmonary exercise test; CRQ, chronic respiratory questionnaire; HBG, home-based group; HRQL, health-related quality of life; LL, lower limb; MRC, Medical Research Council; OBG, outpatient-based group; RMT, respiratory muscle training; SGRQ, Saint George’s Respiratory Questionnaire; SpO2, peripheral oxygen saturation; ST, strength training; SWT, shuttle walking test; TDI, Transitional Dyspnea Index; UL, upper limb; UST, upper limb strength training; VO2, oxygen uptake; VO2, LAT, oxygen uptake at which the lactic acidosis threshold was detected; WR, work rate. a Not considering lost to follow-up. b RCT is a noninferiority study.

HBG: 61(6), CG: 57(8)

HBG: 26(9), CG: 27(11)

HBG: 65(15), Busch and CG: 66(15) McClementes [14]

HBG: 40(6), OBG: 41(6)

HBG: 42(16), CG: 40(16)

HBG: 64(8), CG: 63(7)

Herna´ndez et al. [15]

FEV1 (%)

Age (years)

Study

COPD patient characteristics

Table 1 (continued )

138 Obstructive, occupational and environmental diseases

Rehabilitation in pulmonary disease patients Vieira et al. 139

weights with each arm [11 ] or by an electronic strain gauge and Jamar hand dynamometer [17]. Physical activity was not assessed in any of the trials. Adverse events were only reported in two studies [9 ,13] and group comparison was reported only in one study [9 ]. Methodology quality

Overall, the methodological quality of the studies was average to poor (Table 2). Concealment of allocation was described in five studies, adequate follow-up in six and intention-to-treat analysis in one. Blinding of patients and therapists cannot apply in this setting of intervention, that is, home-based pulmonary rehabilitation. Blinding of assessors who measure at least one key outcome was indicated in only three studies. Between-group statistical comparisons were often not reported. Only two studies presented sample size calculation [9 ,13]. Most of the studies that were aimed at showing superiority of home-based pulmonary rehabilitation over standard care were likely underpowered. The studies comparing home-based and hospital-based pulmonary rehabilitation were not designed as a noninferiority trial except for one [9 ]. Health-related quality of life and exercise capacity

Tables 3 and 4 present the clinical outcomes, that is, HRQL and exercise capacity, for the studies in which data were provided with sufficient detail to be tabulated. In the studies comparing home-based pulmonary rehabilitation and standard care (Table 3), six assessed HRQL using the CRQ [15,18,19] or the SGRQ [8,13,17]. Most of the studies showed improvement (statistically and clinically significant) from baseline in the home-based rehabilitation groups, whereas it was usually not achieved in the standard care groups. Between-group differences were reported in only three of the six studies. In these three studies [13,15,19], the differences were not provided but reported as statistically significant. Most of the studies showed improvement in exercise capacity as assessed by the 6-min or 12-min walk test, shuttle walk test, step test and constant work rate test from baseline in the home-based rehabilitation groups but not the standard care groups. Between group differences were

reported in only two studies. In these two studies [13,15], the differences for the 6-min walk test [13] and the constant work rate test [15] were statistically significant. Of the studies comparing a home-based pulmonary rehabilitation with a hospital-based program (Table 4), all three assessed the HRQL using the CRQ [9 ,11 ,12]. There was a statistically and clinically significant improvement of the dyspnea domain after pulmonary rehabilitation in both groups, that is, home-based and hospital-based programs. There were no statistically significant differences between groups and the differences were under the minimal clinical important difference (MCID < 0.5). Two studies assessed exercise capacity using maximal work level [10]. Maximal work level improved in homebased and hospital-based rehabilitation (data not provided in the table) [10]. No statistically significant differences were shown between both groups, but improvement at follow-up (3 and 18 months) was reported as better maintained after the home-based program. Peak oxygen consumption (VO2) [12] had a statistically significant improvement from baseline only in the hospital-based program and comparing the responses of the two groups. Two studies assessed constant work rate exercise [9 ,12] and both groups showed improved endurance time. In one study, the improvement was similar between groups [9 ]. In the other study [12], the increase was larger in the hospital-based program. Six-minute walking test was assessed in two studies [9 ,11 ] and 4-min walking test in one [10] (data not provided in the table). Within-group differences from baseline were usually statistically significant, but they did not always reach the minimal clinical improvement difference. No statistically significant between-group differences were observed in any of the studies at follow-up. Respiratory symptoms and muscle strength

There was a reduction in dyspnea in both groups in one study [17] and a reduction in the home-based group but not in the standard care in another study [18]. There was a

Table 2 Methodological quality

PeDro criteria

Ferna´ndez et al. [8]

Gu¨ell et al. [11 ]

Maltais et al. [9 ]

Resqueti et al. [18]

Boxall et al. [13]

Murphy et al. [17]

Singh et al. [19]

Herna´ndez et al. [15]

PuenteMaestu et al. [12]

Strijbos et al. [10]

Busch and McClements [14]

McGavin et al. [16]

Eligibility criteria Random allocation Concealed allocation Baseline comparability Blind patients Blind therapists Blind assessors Adequate follow-up Intention to treat analysis Between-group comparisons Point estimates and variability

Yes Yes No Yes NA NA No Yes No No Yes

Yes Yesa Yes Yes NA NA Yes Yes No Yes Yes

Yes Yes Yes Yes NA NA Yes Yes Yes Yes Yes

Yes Yesa Yes Yes NA NA No Yes No No Yes

Yes Yes Yes Yes NA NA No No No Yes Yes

Yes Yes Yes Yes NA NA No No No No Yes

Yes Yesa No Yes NA NA No No No Yes Yes

No Yesa No Yes NA NA No No No Yes Yes

Yes Yes No Yes NA NA No No No Yes Yes

Yes Yes No Yes NA NA No Yes No Yes Yes

No Yes No Yes NA NA Yes No No Yes Yes

No Yesa No Yes NA NA No Yes No Yes Yes

NA, not applicable. a The precise method of randomization was not specified.

n ¼ 19 0.1 (NS) 0.1 (NS) 0.4 (NS) 0.0 (NS) n ¼ 23 1.4 0.6 (NS) 2.0 n ¼ 13 8.8 7.7 (NS) 10.7 (NS) 3.0 (NS) n ¼ 20 0.08 (NS) 0.05 (NS) 0.06 (NS) 0.15 (NS) n ¼ 17 0.30y 0.05 (NS)

0.03 (NS) 0.29 (NS)

n ¼ 19 0.5 0.6 (NS) 0.5y 0.3 (NS) n ¼ 23 5.8 2.0 (NS) 8.1 n ¼ 13 17.8 1.6 (NS) 25.3 19.3 n ¼ 20 0.96z 0.89z 0.90z 0.91z n ¼ 20 1.08z 0.62z 0.92z 0.81z

Mastery

Fatigue Emotion

Reported as statistically significant for all domains

Reported as statistically significant for all domainsz

NA NA (NS) NA (NS) NA NA

CG n ¼ 14 2.5 (NS) 9.1 (NS) 0.0 (NS) 1.8 (NS) n ¼ 15 0.4 (NS) 0.0 (NS) 0.4 (NS) 0.5 (NS)

HBG n ¼ 27 14.7z 22.8z 11.2y 14.3z n ¼ 14 0.6 0.5 (NS) 0.9 0.3 (NS)

Within-group difference from baseline

HRQL: follow-up

HBG–CG

Betweengroup difference

12MWT (m) CPET Peak WR (W) Peak VO2 (mmol/min)

Step test: physical work (J) CPET: physical work (J)

CEPT Peak WR (W) Peak VO2 (l/min)

CWRT time (min)

SWT (m)

6MWT (m)

SWT (m) Step test (s)

6MWT (m)

3MWT (m)

6MWT (m)

Exercise capacity test

n ¼ 17 0.3 (NS)

n ¼ 20 0 (NS)

2.46 n ¼ 12 19 (NS)

0.18 n ¼ 12 64z 14.4 6.8 (NS)

2.6 (NS) 5.3

2.9 (NS) 0.1 (NS) n¼7 2.65

2.8 (NS) 0.1 (NS) n¼7 1.66

2.4 (NS)

n ¼ 20 6.7 (NS)

n ¼ 20 54.2z

18.9y

n ¼ 13 10 (NS) 2 (NS)

n ¼ 23 4.2

n ¼ 23 39.0

n ¼ 13 106z 44z

n ¼ 19 2.8 (NS)

n ¼ 19 18.9z

HBG

Within-group difference from baseline

NA NA NA

n¼7 NA (NS)

Reported as NS Reported as statistically significantz

NA NA

HBG–CG

Betweengroup difference

Exercise capacity: at the end of the rehabilitation program

n ¼ 14 18.5

n ¼ 27 79z

HBG

n ¼ 15 7.1 (NS)

n ¼ 14 13 (NS)

Within-group difference from baseline

HBG–CG

Betweengroup difference

Exercise capacity: follow-up

12MWT, 12-min walking test; 3MWT, 3-min walking test; 4MWT, 4-min walking test; 6MWT, 6-min walking test; CG, control group; CPET, cardiopulmonary exercise test; CRQ, Chronic Respiratory Questionnaire; CWRT, constant work rate test; HBG, home-based group; HRQL, heath-related quality of life; NA, not available or not provided; NS, not significant; SGRQ, Saint George’s Respiratory Questionnaire; SWT, shuttle-walking test; VO2, oxygen consumption; WR, work rate. In the SGRQ, a lower score represents an improvement in HRQL. P < 0.05. y P 0.01. z P 0.001.

McGavin et al. [16]

Busch and McClements [14]

Herna´ndez et al. [15]

Singh et al. [19]

Murphy et al. [17]

Boxall et al. [13]

Resqueti et al. [18]

Ferna´ndez et al. [8]

HBG–CG

HBG

SGRQ Total Symptoms Activity Impact CRQ Dyspnea Mastery Fatigue Emotion SGRQ Total Symptoms Activity Impact SGRQ Total Symptoms Activity Impact CRQ Dyspnea Mastery Fatigue Emotion CRQ Dyspnea

HRQL test

Study

Betweengroup difference

Within-group difference from baseline

HRQL: at the end of the rehabilitation program

Table 3 Clinical outcomes of home-based pulmonary rehabilitation in comparison to standard care

140 Obstructive, occupational and environmental diseases

CRQ Dyspnea Mastery Fatigue Emotion CRQ Dyspnea Mastery Fatigue Emotion SGRQ Total Symptom Activity impact CRQ Dyspnea Mastery Fatigue Emotion

HRQL test n ¼ 23 0.56 NS NS NS n ¼ 107 0.82z 0.49z 0.36z 0.35z 7.7z 9.2z 5.9z 8.1z n ¼ 20 0.8y 1.35y 0.7y 0.67y

n ¼ 28 0.87 0.6 0.56 0.76 n ¼ 109 0.78z 0.51z 0.46z 0.38z 6.3z 3.1 (NS) 5.7z 7.9z n ¼ 21 0.72y 0.75y 0.82y 0.43y NS NS NS NS

0.05 (NS) 0.02 (NS) 0.10 (NS) 0.03 (NS) 1.4 (NS) 6.1y 0.2 (NS) 0.2 (NS)

0.21 (NS) 0.42 (NS) 0.19 (NS) 0.58y

HBG–OBG

OBG

HBG n ¼ 20 0.55 NS NS NS n ¼ 107 0.62z 0.39z 0.25y 0.28z 4.5z 6.9z 1.6 (NS) 5z

HBG n ¼ 23 0.66 0.6 0.57 0.75 n ¼ 109 0.46z 0.30z 0.10 (NS) 0.20y 3.5z 6.3z 0.3 (NS) 4.3z

OBG

Within-group difference from baseline

HRQL: follow-up

0.16 (NS) 0.09 (NS) 0.18 (NS) 0.08 (NS) 1.0 (NS) 0.6 (NS) 1.3 (NS) 0.7 (NS)

0.13 (NS) 0.50 (NS) 0.32 (NS) 0.73y

HBG–OBG

Betweengroup difference

CPET: peak VO2 (ml/min)

CWRT: time (min)

CWRT: time (s)

6MWT (m)

Exercise capacity test

5 (NS)

n ¼ 20 3.9y

246

n ¼ 89 8 (NS)

n ¼ 23 Difference NA

HBG

Within-group difference from baseline

NS Difference NA 110y

9 (NS)

3 (NS)

8.69 (NS)

HBG–OBG

Betweengroup difference

n ¼ 21 8y

237

n ¼ 95 11

n ¼ 28 Difference NA

OBG

Exercise capacity: at the end of the rehabilitation program

122

n ¼ 89 0 (NS)

n ¼ 20 Difference NA

HBG

Within-group difference from baseline

Exercise capacity: follow up

5 (NS) 27 (NS)

6.55 (NS)

HBG–OBG

n ¼ 95 5 (NS)

n ¼ 23 Difference NA

OBG

Betweengroup difference

6MWT, 6-min walking test; CPET, cardiopulmonary exercise test; CRQ, Chronic Respiratory Questionnaire; CWRT, constant work rate test; HBG, home-based group; HRQL, heath-related quality of life; NA, not available or not provided; NS, not significant; OBG, outpatient-based group; SGRQ, Saint George’s Respiratory Questionnaire; VO2, oxygen consumption; WR, work rate. In the SGRQ a lower score represents an improvement in HRQL. Guell et al. study: between-group differences were adjusted for baseline values by analysis of covariance. b Puente-Maestu et al. study: there were no statistically significant differences in the magnitude of changes or the proportion of patients who had clinically meaningful changes of the score of each domain. P < 0.05. y P 0.01. z P 0.001.

Puente-Maestu et al. [12]b

Maltais et al. [9 ]

Gu¨ell et al. [11 ]

Study

Betweengroup difference

Within-group difference from baseline

HRQL: at the end of the rehabilitation program

Table 4 Clinical outcomes of home-based pulmonary rehabilitation in comparison to hospital-based program

Rehabilitation in pulmonary disease patients Vieira et al. 141

142 Obstructive, occupational and environmental diseases

reduction in dyspnea in both groups in one study [17] and in the home-based group, but not in the standard care, in the other [18]. Borg scale at the end of an exercise test was evaluated in five studies [8,10,13,15,17]. There were no statistically significant changes in either group in one study [17], a decrease in the Borg scale score in the homebased group but without significant difference between groups in another study [15], a decrease only in the homebased group in two studies [8,10], which was maintained over 18 months [10], and a decrease in the home-based group compared with the standard care group in another study [13]. Dyspnea was evaluated using Borg scale in two studies [10,12] comparing home-based pulmonary rehabilitation with a hospital-based program. There was a decrease in the Borg scale score in the hospital-based group, but without statistically significant difference between groups in one study [12], whereas it did not change significantly in both treatment groups in the other study [10]. Muscle strength was assessed in one study [17] evaluating home-based pulmonary rehabilitation in comparison to standard care, and no statistically significant change was shown in either group. It was assessed in one study [11 ] evaluating home-based pulmonary rehabilitation in comparison to a hospital-based program, and it was shown that arm strength increased in the home-based group and hospital-based group at 9 weeks and 6 months, without statistically significant differences between groups. Exacerbations, hospital admissions and adverse events

Exacerbation rate and/or hospital admissions were assessed in three studies [9 ,13,17]. There was no difference in hospital admissions and average length of stay between groups except for one study in which there was a decrease in the home-based group at 6 months but not in the standard care group [13]. Adverse events with respect to the exercise training program were not reported in most of the studies. In one study [13], it was reported specifically that one of the most common problems was shoulder and arm pain for which many patients were required to stop the exercise. In another study [9 ], adverse events were systematically recorded and were mostly mild. Although there were 51 serious adverse events reported in the outpatient rehabilitation group and 52 in the home rehabilitation group, most adverse events were related to COPD exacerbations requiring hospitalization and none were due to the exercise training program.

Discussion This systematic review of the currently available randomized clinical trials of home-based pulmonary

rehabilitation for COPD patients showed that homebased pulmonary rehabilitation has the potential to improve HRQL and exercise capacity as compared to standard care. Furthermore, studies that compared homebased pulmonary rehabilitation with hospital-based outpatient programs have not been able to show statistically and clinically significant difference for HRQL and exercise capacity. Although only few studies have systematically assessed the risk of adverse events with home-based rehabilitation, when reported, they were usually mild events. These results apply to patients with moderate to severe COPD (GOLD 3 and 4), 60 years old or more and with stable disease. The home-based rehabilitation programs included endurance training (walking, cycling and/or climbing stairs) and were mostly of 8-week duration or more, three sessions per week or more and at least 30 min per session. No direct supervision was provided with home-based rehabilitation except for an initial visit in some programs and follow-up, which could be a visit or a telephone contact. In the largest trial [9 ], patients were visited weekly for the first 2 weeks to make sure they complied with their exercise training program and follow-up was done weekly by telephone contacts. In some studies, patients were supplied with a pedometer [11 ,12]. This review has many limitations. One of the main limitations of this systematic review is the quality of the randomized clinical trials. Most of the trials were of average to poor quality, that is, for many studies, there was no description of concealment of allocation, no blinding of the assessors and no intention-to-treat analysis. Except for one [9 ], most of the studies had very small sample size and incomplete follow-up. This study with the largest sample size was also the one showing the best quality. This trial, which was designed as a noninferiority trial, showed that home-based pulmonary rehabilitation with telephone follow-up can achieve similar health benefits as a hospitalbased outpatient program with no evidence of detrimental effects. The studies were for most of relatively short duration; it is difficult to extrapolate these results over 12–18 months. Furthermore, the studies do not allow establishing the effect of home-based rehabilitation on exercise maintenance. It is commonly believed that patients in home-based pulmonary rehabilitation programs would not be amenable to high-intensity training. This did not seem to be the case in many of the studies in which the information was provided. Training intensity for the home-based rehabilitation programs, when specified, were aiming at 60–80% of peak work rate, 90% of velocity in 6-min walk test and 3–4 km/h marked with pedometer including 10 min to elicit moderate dyspnea. However, none of

Rehabilitation in pulmonary disease patients Vieira et al. 143

the studies provided confirmation that these targets for training intensity were achieved.

Conclusion Self-monitored, home-based pulmonary rehabilitation is useful and, if properly done, it may be an equivalent alternative to outpatient pulmonary rehabilitation. Many programs with endurance training have shown to be beneficial in improving HRQL and exercise capacity. Home-based pulmonary rehabilitation may help to expand the recognition, application and accessibility of pulmonary rehabilitation for patients with COPD. Although no economic analysis has been done, we have no reason to believe that home-based rehabilitation would be more expensive than outpatient hospital-based programs. Further work is necessary to better understand the impact of long-term benefits of home-based pulmonary rehabilitation. It remains to be shown whether homebased rehabilitation is any different than hospital-based outpatient programs to increase physical activities in daily life. Finally, pulmonary rehabilitation is more than just exercise training. We still have to define how to integrate self-management education to home exercise training for promoting positive health behavior change, exercise maintenance and optimizing disease control.

Acknowledgements The authors have no financial relationships with commercial interests relevant to this topic. Operating funds were provided by the Respiratory Health Network of the Fonds de la Recherche en Sante´ du Que´bec (FRSQ). Danielle Soares Rocha Vieira is a PhD candidate supported by CAPES (Coordenaçaõ de Aperfeiçoamento de Pessoal de Nı´vel Superior).

References and recommended reading Papers of particular interest, published within the annual period of review, have been highlighted as: of special interest of outstanding interest Additional references related to this topic can also be found in the Current World Literature section in this issue (pp. 162–163).

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