Pulmonary Rehabilitation Frequency in COPD Patients

NCT07575841 | Not Yet Recruiting

• 1 other identifier: HUFAlcorcon
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

COPD; COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPD; Exercise training; Supervised Exercise; Home-based Rehabilitation; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (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.

  Change from baseline to 8 weeks (end of intervention)

Secondary Outcomes (14)

• Maximal inspiratory pressure (MIP)

  Change from baseline to 8, 12, and 24 weeks

• Maximal expiratory pressure (MEP)

  Change from baseline to 8, 12, and 24 weeks

• Quadriceps muscle strength

  Change from baseline to 8, 12, and 24 weeks

• Five-times sit-to-stand test (5STS)

  Change from baseline to 8, 12, and 24 weeks

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

  Change from baseline to 8, 12, and 24 weeks

Study Arms (2)

Pulmonary Rehabilitation 3 Days/Week

EXPERIMENTAL

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

Pulmonary Rehabilitation 1 Day/Week

EXPERIMENTAL

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

Interventions

Pulmonary Rehabilitation BEHAVIORAL

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

Pulmonary Rehabilitation 1 Day/Week; Pulmonary Rehabilitation 3 Days/Week

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Fundación Alcorcón: lead

Related Publications (30)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and care providers cannot be blinded. Outcome assessors are blinded to group allocation. Baseline and post-intervention evaluations are conducted by different assessors. Personnel performing functional tests, muscle strength assessments, and administering clinical scales remain unaware of treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05