Pulmonary Rehabilitation Frequency in COPD Patients

Official title

Comparative Efficacy of a Supervised Pulmonary Rehabilitation Program Performed 3 Days/Week Versus 1 Day/Week in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomized Clinical Trial

Overview

Chronic obstructive pulmonary disease (COPD) is a common condition that can cause breathlessness and reduced physical capacity. Pulmonary rehabilitation (PR) is an effective treatment, but traditional programs often require patients to attend sessions several times per week, which may limit participation. This study aims to compare the effectiveness of two supervised pulmonary rehabilitation programs: one performed 3 days per week and another performed 1 day per week, both over an 8-week period and including additional home-based exercises. The main objective is to determine whether the lower-frequency program is not inferior to the higher-frequency program in improving functional capacity, measured by the six-minute walk test. Secondary outcomes include dyspnea, quality of life, muscle strength, physical activity, adherence, exacerbations, and safety. The results of this study may help optimize pulmonary rehabilitation programs and improve accessibility for patients with COPD.

Detailed description

This is a randomized, parallel-group clinical trial designed to evaluate the non-inferiority of a supervised pulmonary rehabilitation (PR) program performed once weekly compared with a program performed three times weekly in patients with stable chronic obstructive pulmonary disease (COPD).

Participants will be recruited from a tertiary care hospital and randomly assigned to one of two intervention groups: (1) supervised PR three days per week or (2) supervised PR one day per week. Both interventions will be conducted over 8 weeks and will include structured exercise training and educational components, complemented by a home-based program.

The primary outcome is functional capacity assessed by the six-minute walk test. Secondary outcomes include dyspnea, health-related quality of life, peripheral muscle strength, physical activity levels, adherence to the intervention, incidence of exacerbations, and safety.

Statistical analyses will be conducted according to both intention-to-treat and per-protocol principles. A non-inferiority framework will be applied, and appropriate mixed-effects models will be used to assess differences between groups over time.

Interventions

• Behavioral Pulmonary Rehabilitation
  Supervised pulmonary rehabilitation program including exercise training and educational components, complemented by a home-based program.

Primary outcome measures

• Functional capacity assessed by the six-minute walk test (6MWT) [Time frame: Change from baseline to 8 weeks (end of intervention)]

Secondary outcome measures (12)

• Maximal inspiratory pressure (MIP) [Time frame: Change from baseline to 8, 12, and 24 weeks]
• Maximal expiratory pressure (MEP) [Time frame: Change from baseline to 8, 12, and 24 weeks]
• Quadriceps muscle strength [Time frame: Change from baseline to 8, 12, and 24 weeks]
• Five-times sit-to-stand test (5STS) [Time frame: Change from baseline to 8, 12, and 24 weeks]
• One-minute sit-to-stand test (1-min STS) [Time frame: Change from baseline to 8, 12, and 24 weeks]
• Dyspnea assessed by the modified Medical Research Council (mMRC) scale [Time frame: Change from baseline to 8, 12, and 24 weeks]
• COPD Assessment Test (CAT) [Time frame: Change from baseline to 8, 12, and 24 weeks]
• Short Form-36 Health Survey (SF-36) [Time frame: Change from baseline to 8, 12, and 24 weeks]
• Hospital Anxiety and Depression Scale (HADS) [Time frame: Change from baseline to 8, 12, and 24 weeks]
• Physical activity assessed by the International Physical Activity Questionnaire (IPAQ) [Time frame: At 8 and 24 weeks]
• Adherence to pulmonary rehabilitation program [Time frame: During the 8-week intervention period]
• COPD exacerbations [Time frame: Up to 24 weeks]

Eligibility criteria

IInclusion criteria

• Diagnosis of COPD confirmed by spirometry (FEV₁/FVC <0.70)
• Modified Medical Research Council (mMRC) dyspnoea scale ≥2
• Ability to actively participate and perform physical exercise
• Signed informed consent

Exclusion criteria

• Unstable cardiac or musculoskeletal comorbidity contraindicating or limiting exercise
• Moderate to severe cognitive impairment or inability to understand instructions
• Recent participation (<6 months) in a complete pulmonary rehabilitation programme
• Inability to attend the centre 1-3 days/week according to group allocation
• Current participation in any structured pulmonary rehabilitation programme or supervised rehabilitation intervention in another centre.
• Active oncological treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Junta de Andalucía. Cuestionario de actividad física IPAQ [Internet]. [citado 2026 May 4]. Disponible en: https://www.juntadeandalucia.es/export/drupaljda/salud_5af95872aeaa7_cuestionario_actividad_fisica_ipaq.pdf
• Armijo S, Behrens C, Giaconi Smoje ME, Hurtado Mura A, Fernández MR, Parra Ponce P, et al. Validación de la versión en español de un instrumento de evaluación de la comunicación centrada en el paciente en OSCE. Educación médica [Internet]. 2021 [citado 4 de mayo de 2026];22(4):193-8. Disponible en: https://dialnet.unirioja.es/servlet/articulo?codigo=8015048
• Nikolovski A, Gamgoum L, Deol A, Quilichini S, Kazemir E, Rhodenizer J, Oliveira A, Brooks D, Alsubheen S. Psychometric properties of the Hospital Anxiety and Depression Scale (HADS) in individuals with stable chronic obstructive pulmonary disease (COPD): a systematic review. Disabil Rehabil. 2024 Apr;46(7):1230-1238. doi: 10.1080/09638288.2023.2182918. Epub 2023 Mar 2. PMID 36861817
• Benzo R, Flume PA, Turner D, Tempest M. Effect of pulmonary rehabilitation on quality of life in patients with COPD: the use of SF-36 summary scores as outcomes measures. J Cardiopulm Rehabil. 2000 Jul-Aug;20(4):231-4. doi: 10.1097/00008483-200007000-00003. PMID 10955263
• Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581. PMID 10377201
• Gephine S, Bergeron S, Tremblay Labrecque PF, Mucci P, Saey D, Maltais F. Cardiorespiratory Response during the 1-min Sit-to-Stand Test in Chronic Obstructive Pulmonary Disease. Med Sci Sports Exerc. 2020 Jul;52(7):1441-1448. doi: 10.1249/MSS.0000000000002276. PMID 31977637
• Farley C, Newman ANL, Phillips SM, Smith-Turchyn J, Brooks D. Measurement properties of the sit-to-stand test in community-dwelling people with chronic obstructive pulmonary disease: a COSMIN systematic review. Thorax. 2026 May 14;81(6):581-590. doi: 10.1136/thorax-2025-223967. PMID 41386962
• Sentanin AC, de Facio CA, da Silva MMC, Sousa FC, Arcuri JF, Mendes RG, Di Lorenzo VAP. Reliability of Quadriceps Femoris Muscle Strength Assessment Using a Portable Dynamometer and Protocol Tolerance in Patients With Chronic Obstructive Pulmonary Disease. Phys Ther. 2021 Sep 1;101(9):pzab107. doi: 10.1093/ptj/pzab107. PMID 33792725

Identifiers

NCT: NCT07575841 · HUFAlcorcon

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗