Pulmonary Rehabilitation Frequency in COPD Patients

May 4, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

158

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Pulmonary Rehabilitation
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.
Behavioral: Pulmonary Rehabilitation
Supervised pulmonary rehabilitation program including exercise training and educational components, complemented by a home-based program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity assessed by the six-minute walk test (6MWT)
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal inspiratory pressure (MIP)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: At 8 and 24 weeks
Physical activity levels assessed using the IPAQ questionnaire.
At 8 and 24 weeks
Adherence to pulmonary rehabilitation program
Time Frame: During the 8-week intervention period
Adherence defined as the percentage of attended supervised sessions.
During the 8-week intervention period
COPD exacerbations
Time Frame: Up to 24 weeks
Number of COPD exacerbations during follow-up.
Up to 24 weeks
Emergency department visits and hospital admissions
Time Frame: Up to 24 weeks
Number of COPD-related emergency visits and hospital admissions.
Up to 24 weeks
Adverse events
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Fundación Alcorcón

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUFAlcorcon

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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