Effect of Home-Based Pulmonary Rehabilitation (PR)

Hawler Medical University

Status: Completed

Conditions: COPD

Treatments: Behavioral: pulmonary rehabilitation (PR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06954948

home-based PR

Details and patient eligibility

About

This clinical trial aims to assess the effectiveness of home-based pulmonary rehabilitation in improving the clinical outcomes of patients with COPD.

Research questions :

RQ1: Is there a significant difference in the exacerbation rates before and after implementing the program? RQ2: Is there a significant improvement in the quality of life before and after implementing the program? RQ3: Is there a significant improvement in 6MWT before and after implementing the program? RQ4: Is there a significant improvement in COPD patients' modified Medical Research Council dyspnea scale before and after the implementation of the program?

Intervention group will receive pulmonary rehabilitation at home or any place they designated over eight consecutive weeks. Two sessions per week and continuous phone calls. Participants will also be given a structured manual to record their activities and follow instructions on days without supervision. While the control group receive routine care at the respiratory unit.

Enrollment: 128 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of COPD, confirmed by spirometry and pulmonologist
• Age ≥40 years (to avoid recruiting participants with asthma rather than COPD)
• Current or previous smoker (≥10 packs per year)
• Confidence in using the proposed pulmonary rehabilitation (PR) system
• Kurdish language fluency
• Willingness to participate and sign an informed consent form.

Exclusion criteria

• patients with pulmonary hypertension
• patients with movement disorders and/or a history of falls
• patients with severe sensory or cognitive impairment
• patients with symptomatic ischemic heart disease
• patients with musculoskeletal degenerative disease
• Patients out site of the city or inability to be contacted

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 1 patient group

COPD

Experimental group

Description:

64 stable COPD patients receive eight week structured pulmonary rehabilitation program. Two session per week (1-2 hours) with continuous phon call. participants will be given structured manual. Primary outcomes are changes in the exacerbation rate, functional status and mMRC. Secondary outcomes are improvement in the health related quality of life and medication adherence with correct use of inhaler. To validate internal consistency all the outcomes will be compared with 64 patients in control group.

Treatment:

Behavioral: pulmonary rehabilitation (PR)