Effect of a Home-Based Pulmonary Rehabilitation on Patients' Outcome With COPD In Limited Recourses Country
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hawler Medical University
- Enrollment
- 128
- Locations
- 2
- Primary Endpoint
- Exacerbation rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: pulmonary rehabilitation (PR) (Behavioral)
Outcomes
Primary Outcomes
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.
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)
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
- 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)
Investigators
Newroz Ghazi Aziz
Assist Professor
Hawler Medical University