Clinical trial NCT06954948: Effect of Home-Based Pulmonary Rehabilitation
Official title: Effect of a Home-Based Pulmonary Rehabilitation on Patients' Outcome With COPD In Limited Recourses Country
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD
Keywords: COPD
Exacerbation
6MWD
CAT
mMRC
CRQ
Pulmonary Rehabilitation
MARS-5
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 82
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post test will be adopted to assess the difference in the clinical outcomes of 82 staple patients with COPD after home-based pulmonary rehabilitation
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Exacerbation rate
timeFrame: eight weeks after the implementation of the program
measure: Functional status (exercise capacity)
timeFrame: eight weeks after the program implementation
measure: mMRC
timeFrame: eight weeks after the program implementation
Secondary outcomes:
measure: CAT
timeFrame: eight weeks after the program implementation
measure: Chronic Respiratory Questionnaire (CRQ)
timeFrame: eight weeks after the program implementation
measure: Medication adherence assessment with MARS-5
timeFrame: eight weeks after the program implementation
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Medical University
state: Kurdistan
Study officials:
References: