Effect of Home-Based Pulmonary Rehabilitation

NCT ID: NCT06954948

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pre-post test will be adopted to assess the difference in the clinical outcomes of 64 staple patients with COPD after home-based pulmonary rehabilitation compared with 64 patients in control group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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COPD

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.

Group Type EXPERIMENTAL

pulmonary rehabilitation (PR)

Intervention Type BEHAVIORAL

PR is an exercise and education programme designed for people with lung disease who experience symptoms of breathlessness.

Interventions

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pulmonary rehabilitation (PR)

PR is an exercise and education programme designed for people with lung disease who experience symptoms of breathlessness.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hawler Medical University

OTHER

Sponsor Role lead

Responsible Party

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Newroz Ghazi Aziz

Assist Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hawler Medical University

Erbil, Kurdistan, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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home-based PR

Identifier Type: -

Identifier Source: org_study_id

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