Effect of Home-Based Pulmonary Rehabilitation

Not Applicable

Active, not recruiting

• Conditions: COPD

• Registration Number: NCT06954948
• Lead Sponsor: Hawler Medical University

Brief Summary

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?

Participants 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-05-01
• Study First Posted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Functional status (exercise capacity)	eight weeks after the program implementation	The functional status is measured by the mean difference in the six minute walking distance (6MWD)
mMRC	eight weeks after the program implementation	modified Medical Research Council (mMRC) dyspnea scale is self-reported tool used to assess the severity of breathlessness and it's effect on the activity of daily living when the COPD patients is in the stable condition. The score of 0 demonstrates that the patient has the lowest breathlessness and no restriction to activities and the score of 4 shows that the patient has severe breathlessness and greatest impairment.
Exacerbation rate	eight weeks after the implementation of the program	A COPD exacerbation, or flare-up, occurs when COPD respiratory symptoms become much more severe.

Secondary Outcome Measures

Name	Time	Method
CAT	eight weeks after the program implementation	The COPD Assessment Test™ (CAT) is a self-reported questionnaire that helps patients and healthcare professional to measure the impact that COPD (Chronic Obstructive Pulmonary Disease) is having on patients' wellbeing and daily life. The CAT score is the total of the scores from the eight assessed areas. The maximum score is 40 and it is categorized based on the severity as the follows.; 0-9 low impact 0-20 medium impact 21-30 high impact 31-40 very high impact
Chronic Respiratory Questionnaire (CRQ)	eight weeks after the program implementation	The CRQ is a disease-specific health-related quality of life questionnaire, developed to measure the impact of Chronic Obstructive Pulmonary Disease (COPD) on a person's life. This tool is self-completed questionnaire, it has 20 items, 4 domains (Dyspnea, Fatigue, Emotional Function \& Mastery). The scaling of items is 7-pointing modified Likert Scale (1-7) and 0-7 on dyspnea domain. Higher score indicates better quality of life.
Medication adherence assessment with MARS-5	eight weeks after the program implementation	The MARS-5 Item Questionnaire The MARS-5 questionnaire consists of five questions on forgetting, changing dosage, stopping, skipping, and taking less medication. The score ranges from 5 to 25, where a higher MARS-5 score indicates higher self-reported adherence. One item assesses unintentional non-adherence and four items assess intentional non-adherence.

Trial Locations

Locations (1)

Hawler Medical University; 🇮🇶 Erbil, Kurdistan, Iraq