Effect of Home-Based Pulmonary Rehabilitation (PR)

Effect of a Home-Based Pulmonary Rehabilitation on Patients' Outcome With COPD In Limited Recourses Country

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Behavioral: pulmonary rehabilitation (PR)

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan
    • Erbil, Kurdistan, Iraq, 44001
      • Hawler Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: pulmonary rehabilitation (PR); PR is an exercise and education programme designed for people with lung disease who experience symptoms of breathlessness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbation rate	A COPD exacerbation, or flare-up, occurs when COPD respiratory symptoms become much more severe.	eight weeks after the implementation of the program
Functional status (exercise capacity)	The functional status is measured by the mean difference in the six minute walking distance (6MWD)	eight weeks after the program implementation
mMRC	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.	eight weeks after the program implementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAT	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	eight weeks after the program implementation
Medication adherence assessment with MARS-5	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.	eight weeks after the program implementation
Chronic Respiratory Questionnaire (CRQ)	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.	eight weeks after the program implementation

Collaborators and Investigators

• Sponsor: Hawler Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 21, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Pulmonary Rehabilitation; Exacerbation; CAT; 6MWD; mMRC; CRQ; MARS-5
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: home-based PR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No