Pulmonary rehabilitation (PR) is a fundamental treatment of COPD. Since it remains underutilized, home-based programs and telemedicine may be useful. In this study, the authors wanted to test if a novel home-based, step-guided PR program centered on self-efficacy promotion and telehealth, was feasible and safe.
This quasi-experimental feasibility study included 14 patients with COPD, two consecutive pillars (education and exercise training) and three consecutive exercise training steps of progressive intensity, for 12 weeks. There was a significant reduction in the BODE Index (6±3 to 5±3) and in symptoms and quality-of-life questionnaires. Five patients improved the 6-min walk test with clinical and statistical significance (270±124 to 338±97). Three patients improved FEV1 and CPET, with clinical significance. There was significant improvement in hand-grip strength (29.5±16.5 to 32.9±17). No adverse events reported.
This home-based step-guided PR centered on self-efficacy in COPD is feasible, improves BODE Index and is safe. Randomized controlled studies with larger samples are required.
Rehabilitación pulmonar (RP) es fundamental para EPOC. Estando infrautilizada, programas domiciliarios y telemedicina pueden ser útiles. Los autores querían comprobar si un novedoso programa de RP domiciliaria, centrado en promoción de la autoeficacia y la telesalud, era viable y seguro.
Estudio cuasiexperimental de viabilidad con 14 pacientes, basado en dos pilares (educación y entrenamiento físico) y tres pasos de entrenamiento físico de intensidad progresiva consecutivos, 12 semanas. Se observó una reducción del índice BODE (6±3»5±3), y de los cuestionarios de síntomas y calidad-de-vida. Cinco pacientes mejoraron clínicamente la prueba de marcha de 6-minutos (270±124»338±97). Tres pacientes mejoraron clínicamente el FEV1 y CPET. Se observó una mejora en la fuerza de prensión manual (29.5±16.5»32.9±17). Sin efectos adversos. Este programa de RP domiciliaria, guiado por pasos y centrado en la promoción de la autoeficacia es viable, mejora el índice BODE y es seguro. Se requieren estudios con muestras más amplias.
Pulmonary rehabilitation (PR) is one of the most important treatments of chronic obstructive pulmonary disease (COPD). It is an evidenced-based multidisciplinary and individually tailored approach that includes exercise training (ET), education and behavior change, aiming to improve symptoms, self-efficacy, social skills, and long-term adherence to healthy behaviors. Despite beneficial, PR remains significantly underutilized due to lack of referral, resources and inaccessibility. Home-based PR have shown similar benefits, but the best approach is not defined. Telemedicine may be useful in selected patients, overcoming limitations of PR.1,2
Previous studies investigated the role for telerehabilitation in COPD: it is feasible and effective in improving exercise capacity, health status and use of healthcare resources, with good adherence and patients’ satisfaction. It can be easily implemented and provide PR remotely, is safe and cost-effective,1,3 although some studies did not reach significant results4 or superiority over usual care.5,6
Here we sought to investigate whether the implementation of a novel step-guided home-based PR program in COPD patients, was feasible, safe and efficacious by improving prognosis and survival predictors, measured by the BODE Index.7
MethodsStudy design and ethicsProspective, feasibility, quasi-experimental study based on two consecutive pillars (education and ET) and three consecutive ET steps of progressive intensity.
All components were based on Living Well With COPD recommendations.8
This study was designed in the context of the mentorship COPD Leaders 2022 program promoted by the Portuguese Pulmonology Society with the support of GSK-Portugal.
This study was approved by the institutional ULSRL Ethics Committee (Ref. 37/2023).
All participants signed their informed consent.
Study populationPatients from the institutional PR consultation with COPD GOLD B/E were included between 2023 and 2024. They were referred to the consultation for PR, aiming for better disease control and symptomatic relief.
Patients with severe/unstable comorbidities and/or lack of home-support and surveillance by caregivers were excluded.
Description of the PR programAll patients received educational sessions and materials to help guide ET, as well as equipment (dumbbells, ankle weights, pedometer, oximeter). The ET program had three consecutive steps (4 weeks each), with increased intensity.
Patients only progressed in the steps after revision of the training records (vital signs, Borg scale, training adhesion ≥70%) and assured safety and adequacy of the progression (through target Borg Scale, oxygen saturations, heart-rate intervals, arterial blood pressure and clearly described alarm signs in the learning materials). Training included warm-up and cool-down exercises. Other exercises were prescribed if appropriate (balance exercises).
The intervention adopted telehealth appointments once/twice-weekly: video calls (Microsoft Teams), phone-calls, e-mails, to intercalate/substitute a weekly presential session.
Biometric measures, questionnaires of symptoms were collected during the first and last visit. Pulmonary function and exercise tests were performed 3–6 months before and after PR.
All patients were encouraged to maintain the exercises after completion of the program.
OutcomesThe primary outcome of the study was an improvement in the BODE index by ≥1 point – considered clinically relevant.9
Secondary outcomes included improvement in pulmonary function and exercise capacity with clinical significance (Forced Expiratory Volume in the First Second [FEV1≥100ml]; 6-minute walk test [6MWT≥26m]; progressive cardiopulmonary exercise testing [CPET≥4W]),10 hand-grip strength (HGS), symptoms and quality of life, reduction of exacerbations.
Safety was evaluated by the report of any significant adverse events related with the exercise training.
Feasibility was assessed by the proportion of patients finishing ≥70% of the intervention.
Patients had at least 1-year follow-up after PR.
Data analysisMain results are summarized and presented as n, proportion, mean±SD or median values as appropriate, with 95% confidence intervals. Chi-square tests evaluated associations between categorical variables. All analysis were made with SPSS Statistics 23.
ResultsPatient characteristicsFourteen patients were enrolled in this study, the majority being male, with a mean age of 67±7 years-old (Table 1).
Baseline characteristics of participants.
| Characteristics | Results |
|---|---|
| n (%) | 14 (100) |
| Males, n (%) | 11 (78.6) |
| Age (years), mean±SD | 67±7 |
| Adherence to medical treatment, n (%) | 8 (57.1) |
| Chronic Obstructive Pulmonary Disease characterization | |
| GOLD 1, n (%) | 1 (7.1) |
| GOLD 2, n (%) | 4 (28.6) |
| GOLD 3, n (%) | 5 (35.7) |
| GOLD 4, n (%) | 4 (28.6) |
| GOLD B, n (%) | 12 (85.7) |
| GOLD E, n (%) | 2 (14.3) |
| Triple therapy (LABA/LAMA/ICS), n (%) | 11 (78.6) |
| Long-term oxygen therapy, n (%) | 4 (28.6) |
| Deambulation oxygen therapy, n (%) | 5 (35.7) |
| Non-invasive ventilation therapy, n (%) | 4 (28.6) |
| Smoking habits | |
| Active smokers, n (%) | 3 (21.4) |
| Pack-year units, median±IQR | 50±10 |
| Comorbidities | |
| Obesity, n (%) | 5 (35.7) |
| Heart failure, n (%) | 4 (28.6) |
| Type 2 diabetes mellitus, n (%) | 2 (14.3) |
| Hypertension, n (%) | 9 (64.3) |
| Dyslipidemia, n (%) | 5 (35.7) |
| Osteoarticular pathology, n (%) | 3 (21.4) |
| Pulmonary rehabilitation | |
| Completion of the program, n (%) | 13 (92.9) |
| Adherence after completion of the program, n (%) | 8 (57.1) |
| Complications during the program, n (%) | 0 (0) |
Abbreviations: SD, Standard Deviation; LABA, Long-Acting Beta-Agonist; LAMA, Long-Acting Antimuscarinic; ICS, Inhaled Corticosteroid; IQR, Interquartile Range.
Nine patients had COPD GOLD 3–4, and 2 had previous exacerbations (GOLD E). Most were treated with triple inhaler therapy, 4 patients had long-term oxygen therapy, and 5 had oxygen prescribed for physical effort. Four patients were treated with non-invasive ventilatory therapy.
There was a high prevalence of cardiovascular risk factors such as hypertension (64.3%), dyslipidemia (35.7%) and obesity (35.7%). Four patients had heart failure.
Only one patient accepted to conduct the PR online with videocalls; others were reluctant to this modality.
FeasibilityOnly one patient did not complete the program due to an ocular surgery.
Primary outcomeThere was a statistically significant reduction in the BODE Index after the program (Table 2). Ten patients reduced BODE Index≥1 point (76.9%).
Patients’ variables before and after pulmonary rehabilitation.
| Variables | T0 | T1 |
|---|---|---|
| Annual exacerbations, median [IQR] | 0 [0–1] | 0 [0–1] |
| mMRC, median [IQR] | 4 [1–3] | 2 [0–4] |
| CAT, median [IQR] | 17 [1–11] | 11 [4–22] |
| CFS, median [IQR] | 3 [0–2] | 2 [0–2] |
| LCADL, mean [SD] | 28 [3.33–14.23] | 16 [1.55–4.52] |
| SGRQ, median [IQR] | 53 [10.69–49.28] | 32.99 [5.70–38.82] |
| HADS, median [IQR] | 15 [5–29] | 9 [3–24] |
| 6MWT (m), median [IQR] | 270 [21–163] | 338 [29–152] |
| Increase of ≥26m, n (%) | – | 5 (38.5) |
| FEV1 (L), median [IQR] | 1.14 [0.09–0.81] | 1.21 [0.07–0.92] |
| Increase of ≥100ml, n (%) | – | 3 (23.1) |
| FEV1 (%), median [IQR] | 50 [7–38] | 52 [9–43] |
| VO2Max (ml/min/kg), median [IQR] | 12.36 [1.02–6.65] | 14.84 [1.92–9.14] |
| Maximal WAT, mean [SD] | 56 [4.08–11.69] | 60 [9.83–32.50] |
| Increase of ≥4W, n (%) | – | 3 (50) |
| HGS (kg), median [IQR] | 29.5 [5.1–22.7] | 32.9 [4.3–23.1] |
| BMI (kg/m2), median [IQR] | 27.1 [2.1–13.6] | 25.5 [2.4–12.4] |
| BODE Index, median [IQR] | 6 [1–4] | 5 [0–5] |
| Estimated 4-year survival (%), median [IQR] | 57 [3–49] | 57 [3–23] |
| BODE Index improved ≥1point, n (%) | – | 10 (76.9) |
Abbreviations: T0, Baseline; T1, Reevaluation after Pulmonary Rehabilitation; mMRC, modified Medical Research Council dyspnea scale; CAT, COPD Assessment Test; CFS, Clinical Frailty Scale; LCADL, London Chest Activity of Daily Living scale; SGRQ, St. George's Respiratory Questionnaire; HADS, Hospital Anxiety and Depression Scale; 6MWT, 6-Minute Walk Test; FEV1, Forced Expiratory Volume in the First Second; VO2Max, Maximum oxygen uptake; HGS, Hand Grip Strength; IQR, Interquartile Range; SD, Standard Deviation.
Improvements in the BODE Index were associated with adherence to treatment and PR after the program.
Secondary outcomesThere was a significant improvement in symptoms and quality of life evaluated by the modified Medical Research Council dyspnea scale (mMRC), COPD Assessment Test (CAT), London Chest Activity of Daily Living scale (LCADL) and St. George's Respiratory Questionnaire (SGRQ). Clinical Frailty Scale (CFS) improved and also anxiety/depression evaluated by the Hospital Anxiety and Depression Scale (HADS).
There was an improvement in 6MWT; 5 patients improved with clinical significance. Three patients improved FEV1 with clinical significance and the performance in CPET also increased with clinical significance in 3 patients.
There was a significant improvement in HGS.
Annual exacerbations reduced after PR.
SafetyNo adverse events were reported.
DiscussionThe main observation of this pilot, quasi-experimental feasibility study is that a novel home-based PR strategy that included a step-guided approach, with focus on education prior to ET, at variance with some previous studies,11 was feasible, and presented clinical improved outcomes such as safety, clinical and statistically significant improvements in the BODE Index, which correlates with a reduction in mortality and better prognosis,7 as well as improved HGS.12 We also found statistically significant improvements in all symptoms and quality of life questionnaires as well as pulmonary function and exercise capacity.
To the best of our knowledge, this is the first study that associates a home-based PR program with improved BODE Index and other mortality/prognosis predictors. However, we recognize that its main limitation is the reduced sample size and the lack of a randomized control group.
A study of larger cohorts and longer-term follow-up in a properly designed randomized, prospective and controlled study with mortality analysis is required to validate these results. These findings may contribute to improve access to PR through novel approaches.
Ethical considerationsThis study was approved by the institutional ULSRL Ethics Committee (Ref. 37/2023). All participants signed their informed consent.
Use of artificial intelligenceThis work did not use any form of artificial intelligence.
FundingThe current project was awarded with the Centro Hospitalar de Leiria – Research Grant (2023) which contributed to the acquisition of exercise and monitoring materials to conduct the study.
Authors’ contributions- •
Maria Beatriz Cabaço Santos: Contributed to the conception and design of the work, data acquisition, analysis and interpretation. Also contributed to the writing and reviewing of the work. She approved the final version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
- •
Bruno Cabrita: Contributed to the conception and design of the work, data acquisition, analysis and interpretation. Also contributed to the writing and reviewing of the work. He approved the final version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
- •
Eva Gonçalves: Contributed to the design of the work, data acquisition and interpretation. Also contributed to the reviewing of the work. She approved the final version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
- •
Cláudia Simões: Contributed to the design of the work, data acquisition and interpretation. Also contributed to the reviewing of the work. She approved the final version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
- •
Paula Pinto: Contributed to the conception and design of the work, data acquisition, analysis and interpretation. Also contributed to the writing and reviewing of the work. She approved the final version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
- •
Alvar Agusti: Contributed to the conception and design of the work, data acquisition, analysis and interpretation. Also contributed to the writing and reviewing of the work. He approved the final version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
The authors have no conflicts of interest to declare.
Data availabilityData unavailable for divulgation, due to local ethics regulation.
The authors thank the study participants for their willingness to contribute to medical research and GSK for the unrestricted support provided for the study. Finally, we acknowledge the relevant support and contribution of João Machado, Raquel Oliveira, Paula Simão, João Gomes and Salvato Feijó, for the development of this work.
articles
