Effect of Home-Based Pulmonary Rehabilitation

NCT06954948 | Completed DMC

• 1 other identifier: home-based PR
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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? 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.

Conditions

COPD

Keywords

COPD; Exacerbation; 6MWD; CAT; mMRC; CRQ; Pulmonary Rehabilitation; MARS-5

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• CAT

  eight weeks after the program implementation

• Chronic Respiratory Questionnaire (CRQ)

  eight weeks after the program implementation

• Medication adherence assessment with MARS-5

  eight weeks after the program implementation

Study Arms (1)

COPD

EXPERIMENTAL

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)

Interventions

pulmonary rehabilitation (PR) BEHAVIORAL

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

COPD

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler Medical University

Erbil, Kurdistan, 44001, Iraq

Location

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: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: May 2, 2025
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)