Pulmonary Rehabilitation Frequency in COPD Patients
4 de mayo de 2026 actualizado por: Claudia de la Fuente Escudero, Hospital Universitario Fundación Alcorcón
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
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
158
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Pulmonary Rehabilitation 3 Days/Week
Participants receive supervised pulmonary rehabilitation three times per week for 8 weeks, including exercise training and educational components, complemented by a home-based program.
|
Supervised pulmonary rehabilitation program including exercise training and educational components, complemented by a home-based program.
|
|
Experimental: Pulmonary Rehabilitation 1 Day/Week
Participants receive supervised pulmonary rehabilitation once per week for 8 weeks, including exercise training and educational components, complemented by a home-based program.
|
Supervised pulmonary rehabilitation program including exercise training and educational components, complemented by a home-based program.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional capacity assessed by the six-minute walk test (6MWT)
Periodo de tiempo: Change from baseline to 8 weeks (end of intervention)
|
Functional capacity will be measured using the six-minute walk test (6MWT), expressed as distance walked in meters.
|
Change from baseline to 8 weeks (end of intervention)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximal inspiratory pressure (MIP)
Periodo de tiempo: Change from baseline to 8, 12, and 24 weeks
|
Respiratory muscle strength assessed by maximal inspiratory pressure (MIP), expressed in cmH₂O.
|
Change from baseline to 8, 12, and 24 weeks
|
|
Maximal expiratory pressure (MEP)
Periodo de tiempo: Change from baseline to 8, 12, and 24 weeks
|
Respiratory muscle strength assessed by maximal expiratory pressure (MEP), expressed in cmH₂O.
|
Change from baseline to 8, 12, and 24 weeks
|
|
Quadriceps muscle strength
Periodo de tiempo: Change from baseline to 8, 12, and 24 weeks
|
Peripheral muscle strength assessed by quadriceps dynamometry, expressed in Newtons.
|
Change from baseline to 8, 12, and 24 weeks
|
|
Five-times sit-to-stand test (5STS)
Periodo de tiempo: Change from baseline to 8, 12, and 24 weeks
|
Functional lower limb performance assessed by the time required to complete five sit-to-stand repetitions, expressed in seconds.
|
Change from baseline to 8, 12, and 24 weeks
|
|
One-minute sit-to-stand test (1-min STS)
Periodo de tiempo: Change from baseline to 8, 12, and 24 weeks
|
Functional capacity assessed by the number of repetitions completed in one minute.
|
Change from baseline to 8, 12, and 24 weeks
|
|
Dyspnea assessed by the modified Medical Research Council (mMRC) scale
Periodo de tiempo: Change from baseline to 8, 12, and 24 weeks
|
Dyspnea severity measured using the mMRC scale (range 0-4, higher scores indicate worse dyspnea).
|
Change from baseline to 8, 12, and 24 weeks
|
|
COPD Assessment Test (CAT)
Periodo de tiempo: Change from baseline to 8, 12, and 24 weeks
|
Health status assessed using the CAT questionnaire (range 0-40, higher scores indicate worse health status).
|
Change from baseline to 8, 12, and 24 weeks
|
|
Short Form-36 Health Survey (SF-36)
Periodo de tiempo: Change from baseline to 8, 12, and 24 weeks
|
Health-related quality of life assessed using the SF-36 questionnaire across multiple domains.
|
Change from baseline to 8, 12, and 24 weeks
|
|
Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: Change from baseline to 8, 12, and 24 weeks
|
Psychological status assessed using the HADS questionnaire (range 0-21 per subscale, higher scores indicate worse symptoms).
|
Change from baseline to 8, 12, and 24 weeks
|
|
Physical activity assessed by the International Physical Activity Questionnaire (IPAQ)
Periodo de tiempo: At 8 and 24 weeks
|
Physical activity levels assessed using the IPAQ questionnaire.
|
At 8 and 24 weeks
|
|
Adherence to pulmonary rehabilitation program
Periodo de tiempo: During the 8-week intervention period
|
Adherence defined as the percentage of attended supervised sessions.
|
During the 8-week intervention period
|
|
COPD exacerbations
Periodo de tiempo: Up to 24 weeks
|
Number of COPD exacerbations during follow-up.
|
Up to 24 weeks
|
|
Emergency department visits and hospital admissions
Periodo de tiempo: Up to 24 weeks
|
Number of COPD-related emergency visits and hospital admissions.
|
Up to 24 weeks
|
|
Adverse events
Periodo de tiempo: During the 8-week intervention and follow-up up to 24 weeks
|
Incidence of adverse events, including fatigue, dyspnea, pain, dizziness, and falls.
|
During the 8-week intervention and follow-up up to 24 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- Puhan MA, Gimeno-Santos E, Cates CJ, Troosters T. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016 Dec 8;12(12):CD005305. doi: 10.1002/14651858.CD005305.pub4.
- Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Yawn BP, ZuWallack RL; ATS/ERS Task Force on Policy in Pulmonary Rehabilitation. An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1373-86. doi: 10.1164/rccm.201510-1966ST.
- Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
- Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
- Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.
- 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.
- 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.
- 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.
- 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. 2025 Dec 12:thorax-2025-223967. doi: 10.1136/thorax-2025-223967. Online ahead of print.
- 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.
- Jenkins TO, Edwards GD, Patel S, Canavan J, Kon SSC, Barker RE, Jones SE, Walsh JA, Ingram KA, Maddocks M, Polkey MI, Nolan CM, Man W. Minimal important difference of quadriceps maximal voluntary contraction (QMVC) in COPD: a prospective cohort study. Thorax. 2026 Jan 27:thorax-2025-223799. doi: 10.1136/thorax-2025-223799. Online ahead of print.
- Xie J, Zhu Y, Wang Y, Mo Y, Shi X, Liang WM, Ren FF, Bai Z, Nie F. Effects of pulmonary rehabilitation combined with inspiratory muscle training on lung function and exercise capacity in older patients with COPD: a systematic review and meta-analysis. Front Med (Lausanne). 2025 Jul 9;12:1621375. doi: 10.3389/fmed.2025.1621375. eCollection 2025.
- Lista-Paz A, Langer D, Barral-Fernandez M, Quintela-Del-Rio A, Gimeno-Santos E, Arbillaga-Etxarri A, Torres-Castro R, Vilaro Casamitjana J, Varas de la Fuente AB, Serrano Veguillas C, Bravo Cortes P, Martin Cortijo C, Garcia Delgado E, Herrero-Cortina B, Valera JL, Fregonezi GAF, Gonzalez Montanez C, Martin-Valero R, Francin-Gallego M, Sanesteban Hermida Y, Gimenez Moolhuyzen E, Alvarez Rivas J, Rios-Cortes AT, Souto-Camba S, Gonzalez-Doniz L. Maximal Respiratory Pressure Reference Equations in Healthy Adults and Cut-off Points for Defining Respiratory Muscle Weakness. Arch Bronconeumol. 2023 Dec;59(12):813-820. doi: 10.1016/j.arbres.2023.08.016. Epub 2023 Sep 29. English, Spanish.
- Holland AE, Hill CJ, Rasekaba T, Lee A, Naughton MT, McDonald CF. Updating the minimal important difference for six-minute walk distance in patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2010 Feb;91(2):221-5. doi: 10.1016/j.apmr.2009.10.017.
- Gimeno-Santos E, Vilaro J, Arbilllaga-Etxarri A, Herrero-Cortina B, Ramon MA, Corbero AB, Fernandez-Dominguez JC, Zarate-Tejero C, Barberan-Garcia A, Del Corral T, Jimenez-Reguera B, Lopez A, Lopez-Fernandez D, Treves PM, Martinez-Alejos R, Munoz G, Rios-Cortes A, Ruiz-Lopez K, San Miguel-Pagola M, Sanchez-Cayado N, Valeiro B, Valenza MC, Valenza G, Varas AB, Cordoba S, Vega A, Linares M, Madrid EM, Souto S, Vendrell M, Garcia-Aymerich J. Development and Comparison of Reference Equations for the Six-Minute Walk Test in Spanish Healthy Adults Aged 45-85 Years. Arch Bronconeumol. 2025 Aug;61(8):459-466. doi: 10.1016/j.arbres.2025.01.005. Epub 2025 Jan 17. English, Spanish.
- Nielsen C, Godtfredsen N, Molsted S, Ulrik C, Kallemose T, Hansen H. Supervised pulmonary tele-rehabilitation and individualized home-based pulmonary rehabilitation for patients with COPD, unable to participate in center-based programs. The protocol for a multicenter randomized controlled trial - the REPORT study. PLoS One. 2025 Jan 7;20(1):e0312742. doi: 10.1371/journal.pone.0312742. eCollection 2025.
- Xin H, Wei S, Zheng H, Qi Y, Xu S, Wang B, Jiang W, Deng N, Chen J. Comparison of a Supervised Home-Based Tele-Rehabilitation with Center-Based Pulmonary Rehabilitation: Protocol for a Randomized Non-Inferiority Multicenter Study in Ningxia. Int J Chron Obstruct Pulmon Dis. 2024 Jul 25;19:1707-1719. doi: 10.2147/COPD.S467945. eCollection 2024.
- Nolan CM, Glen C, Walsh JA, Patel S, Barker RE, Polgar O, Spain N, Littlemore H, Jung P, Edwards GD, Jenkins TO, Harvey J, Ingram K, Newby C, Steiner M, Wilson R, Gao W, Fiorentino F, Chukwusa E, May P, Maddocks M, Man WDC. Minimal vs Specialized Exercise Equipment for Pulmonary Rehabilitation: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2526616. doi: 10.1001/jamanetworkopen.2025.26616.
- Pandya K, Davis AM, Anderson MR. Pulmonary Rehabilitation for Adults With Chronic Respiratory Disease. JAMA. 2025 Mar 4;333(9):804-805. doi: 10.1001/jama.2024.24883.
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- Burge AT, Cox NS, Abramson MJ, Holland AE. Interventions for promoting physical activity in people with chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2020 Apr 16;4(4):CD012626. doi: 10.1002/14651858.CD012626.pub2.
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- Lopmeri M, Mattila T, Tokola K, Vasankari T, Jaaskelainen T, Lahti J, Vasankari T. Association of impaired pulmonary function and objectively measured physical activity in a population study. Sci Rep. 2025 Jul 24;15(1):27004. doi: 10.1038/s41598-025-12517-2.
- Cosio BG, Hernandez C, Chiner E, Gimeno-Santos E, Pleguezuelos E, Seijas N, Rigau D, Lopez-Campos JL, Soler-Cataluna JJ, Calle M, Miravitlles M, Casanova C; en nombre del equipo de trabajo de GesEPOC 2021. Spanish COPD Guidelines (GesEPOC 2021): Non-pharmacological Treatment Update. Arch Bronconeumol. 2022 Apr;58(4):345-351. doi: 10.1016/j.arbres.2021.08.010. Epub 2021 Sep 17. English, Spanish.
- Ward TJC, Latimer L, Daynes E, Freeman SC, Ward S, Xu J, Haris M, Bakali M, Reap S, Iqbal M, Wang L, Mavilakandy A, Olaiya A, Aung H, Harvey-Dunstan TC, Singh SJ, Greening NJ, Evans RA, Steiner MC, Sutton AJ. Impact of pulmonary rehabilitation programme design on effectiveness in COPD: a systematic review and component network meta-analysis. EClinicalMedicine. 2025 Aug 20;87:103433. doi: 10.1016/j.eclinm.2025.103433. eCollection 2025 Sep.
- Alison JA, McKeough ZJ, Johnston K, McNamara RJ, Spencer LM, Jenkins SC, Hill CJ, McDonald VM, Frith P, Cafarella P, Brooke M, Cameron-Tucker HL, Candy S, Cecins N, Chan AS, Dale MT, Dowman LM, Granger C, Halloran S, Jung P, Lee AL, Leung R, Matulick T, Osadnik C, Roberts M, Walsh J, Wootton S, Holland AE; Lung Foundation Australia and the Thoracic Society of Australia and New Zealand. Australian and New Zealand Pulmonary Rehabilitation Guidelines. Respirology. 2017 May;22(4):800-819. doi: 10.1111/resp.13025. Epub 2017 Mar 24.
- Venkatesan P. GOLD COPD report: 2025 update. Lancet Respir Med. 2025 Jan;13(1):e7-e8. doi: 10.1016/S2213-2600(24)00413-2. Epub 2024 Dec 5. No abstract available.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de enero de 2027
Finalización primaria (Estimado)
1 de enero de 2028
Finalización del estudio (Estimado)
1 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
4 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de mayo de 2026
Publicado por primera vez (Actual)
8 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HUFAlcorcon
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre EPOC
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PharmaxisTerminado
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Liita Care ApSSuspendidoEPOC | Bronquitis copdDinamarca
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Gala Therapeutics, Inc.Activo, no reclutandoBronquitis crónica | Bronquitis copdEstados Unidos
Ensayos clínicos sobre Pulmonary Rehabilitation
-
University Hospital, LinkoepingLinkoeping University; Ryhov County HospitalDesconocido
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