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NCT Number: NCT07575841

Pulmonary Rehabilitation Frequency in COPD Patients

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.

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Key information

Conditions

COPD COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary rehabilitation

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Quadriceps muscle strength

    Time frame: Change from baseline to 8, 12, and 24 weeks

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

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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.

  9. 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).

  10. 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.

  11. Adherence to pulmonary rehabilitation program

    Time frame: During the 8-week intervention period

    Adherence defined as the percentage of attended supervised sessions.

  12. COPD exacerbations

    Time frame: Up to 24 weeks

    Number of COPD exacerbations during follow-up.

  13. Emergency department visits and hospital admissions

    Time frame: Up to 24 weeks

    Number of COPD-related emergency visits and hospital admissions.

  14. 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Fundación Alcorcón

Other

Registry information

Official study 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

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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