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AzTrials

COPDNCT07575841

Pulmonary Rehabilitation Frequency in COPD Patients

A study testing Pulmonary Rehabilitation in people with COPD and COPD (Chronic Obstructive Pulmonary Disease), run by Hospital Universitario Fundación Alcorcón.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
What is being tested?
Pulmonary Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
No sites listed yet
Study dates
Jan 2027to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

About this study

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

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.

Read more

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.

Read the 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.

Being tested
Pulmonary Rehabilitation
Keywords
COPD, Exercise training, Supervised Exercise, Home-based Rehabilitation, Pulmonary Rehabilitation
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary RehabilitationBehavioural

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

Study groups in NCT07575841
Study groupRoleWhat they receive
Pulmonary Rehabilitation 3 Days/WeekExperimentalParticipants receive supervised pulmonary rehabilitation three times per week for 8 weeks, including exercise training and educational components, complemented by a home-based program.
Receives: Behavioral: Pulmonary Rehabilitation
Pulmonary Rehabilitation 1 Day/WeekExperimentalParticipants receive supervised pulmonary rehabilitation once per week for 8 weeks, including exercise training and educational components, complemented by a home-based program.
Receives: Behavioral: Pulmonary Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional capacity assessed by the six-minute walk test (6MWT)

    Functional capacity will be measured using the six-minute walk test (6MWT), expressed as distance walked in meters.

    Measured: Change from baseline to 8 weeks (end of intervention)

Secondary outcomes (14)

  1. Maximal inspiratory pressure (MIP)

    Respiratory muscle strength assessed by maximal inspiratory pressure (MIP), expressed in cmH₂O.

    Measured: Change from baseline to 8, 12, and 24 weeks

  2. Maximal expiratory pressure (MEP)

    Respiratory muscle strength assessed by maximal expiratory pressure (MEP), expressed in cmH₂O.

    Measured: Change from baseline to 8, 12, and 24 weeks

  3. Quadriceps muscle strength

    Peripheral muscle strength assessed by quadriceps dynamometry, expressed in Newtons.

    Measured: Change from baseline to 8, 12, and 24 weeks

  4. Five-times sit-to-stand test (5STS)

    Functional lower limb performance assessed by the time required to complete five sit-to-stand repetitions, expressed in seconds.

    Measured: Change from baseline to 8, 12, and 24 weeks

  5. One-minute sit-to-stand test (1-min STS)

    Functional capacity assessed by the number of repetitions completed in one minute.

    Measured: Change from baseline to 8, 12, and 24 weeks

  6. Dyspnea assessed by the modified Medical Research Council (mMRC) scale

    Dyspnea severity measured using the mMRC scale (range 0-4, higher scores indicate worse dyspnea).

    Measured: Change from baseline to 8, 12, and 24 weeks

  7. COPD Assessment Test (CAT)

    Health status assessed using the CAT questionnaire (range 0-40, higher scores indicate worse health status).

    Measured: Change from baseline to 8, 12, and 24 weeks

  8. Short Form-36 Health Survey (SF-36)

    Health-related quality of life assessed using the SF-36 questionnaire across multiple domains.

    Measured: Change from baseline to 8, 12, and 24 weeks

  9. Hospital Anxiety and Depression Scale (HADS)

    Psychological status assessed using the HADS questionnaire (range 0-21 per subscale, higher scores indicate worse symptoms).

    Measured: Change from baseline to 8, 12, and 24 weeks

  10. Physical activity assessed by the International Physical Activity Questionnaire (IPAQ)

    Physical activity levels assessed using the IPAQ questionnaire.

    Measured: At 8 and 24 weeks

  11. Adherence to pulmonary rehabilitation program

    Adherence defined as the percentage of attended supervised sessions.

    Measured: During the 8-week intervention period

  12. COPD exacerbations

    Number of COPD exacerbations during follow-up.

    Measured: Up to 24 weeks

  13. Emergency department visits and hospital admissions

    Number of COPD-related emergency visits and hospital admissions.

    Measured: Up to 24 weeks

  14. Adverse events

    Incidence of adverse events, including fatigue, dyspnea, pain, dizziness, and falls.

    Measured: During the 8-week intervention and follow-up up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
158 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07575841
Sponsor's protocol ID
HUFAlcorcon
Status last verified
May 2026
First submitted
4 May 2026
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 33792725

  • 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 Jul 15;81(8):784-790. doi: 10.1136/thorax-2025-223799.

    PubMed 41593004

  • 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.

    PubMed 40703265

  • 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.

    PubMed 37839949

  • 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.

    PubMed 20159125

  • 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.

    PubMed 39890527

  • 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.

    PubMed 39774509

  • 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.

    PubMed 39081777

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary Rehabilitation in people with COPD and COPD (Chronic Obstructive Pulmonary Disease), run by Hospital Universitario Fundación Alcorcón.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional capacity assessed by the six-minute walk test (6MWT) (time frame: Change from baseline to 8 weeks (end of intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07575841, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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Pulmonary Rehabilitation Frequency in COPD Patients | AzTrials