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Completed

NCT Number: NCT06954948

Effect of Home-Based Pulmonary Rehabilitation

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hawler Medical University

Erbil, Kurdistan, 44001, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulmonary rehabilitation (PR)

Behavioral

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

Primary outcomes

  1. Exacerbation rate

    Time frame: eight weeks after the implementation of the program

    A COPD exacerbation, or flare-up, occurs when COPD respiratory symptoms become much more severe.

  2. Functional status (exercise capacity)

    Time frame: eight weeks after the program implementation

    The functional status is measured by the mean difference in the six minute walking distance (6MWD)

  3. mMRC

    Time frame: 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.

Secondary outcomes

  1. CAT

    Time frame: 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

  2. Chronic Respiratory Questionnaire (CRQ)

    Time frame: 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.

  3. Medication adherence assessment with MARS-5

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Acronym: PR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 2, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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