COPDPRNCT06954948
Effect of Home-Based Pulmonary Rehabilitation
A study testing pulmonary rehabilitation (PR) in people with COPD, run by Hawler Medical University at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- COPD
- What is being tested?
- pulmonary rehabilitation (PR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 :
Read more
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
- Being tested
- pulmonary rehabilitation (PR)
- Keywords
- COPD, Exacerbation, 6MWD, CAT, mMRC, CRQ, Pulmonary Rehabilitation, MARS-5
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitation (PR)Behavioural
PR is an exercise and education programme designed for people with lung disease who experience symptoms of breathlessness.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: pulmonary rehabilitation (PR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation rate
A COPD exacerbation, or flare-up, occurs when COPD respiratory symptoms become much more severe.
Measured: 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)
Measured: 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.
Measured: eight weeks after the program implementation
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: eight weeks after the program implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 Sep 2024
- Primary completion1 Mar 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Newroz Ghazi Aziz, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954948
- Sponsor's protocol ID
- home-based PR
- Acronym
- PR
- Status last verified
- Sep 2025
- First submitted
- 10 Apr 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Home-Based Pulmonary Rehabilitation on Patients' Outcome With COPD In Limited Recourses Country
- ClinicalTrials.gov ID
- NCT06954948
- Acronym / sponsor ID
- PR / home-based PR
- Conditions
- COPD
- Keywords
- COPD, Exacerbation, 6MWD, CAT, mMRC, CRQ, Pulmonary Rehabilitation, MARS-5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| COPD | Experimental | Behavioral: pulmonary rehabilitation (PR)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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary rehabilitation (PR)PR is an exercise and education programme designed for people with lung disease who experience symptoms of breathlessness. | Behavioural | COPD |
Primary outcome
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.
3 secondary outcomes
CAT
Time frame: eight weeks after the program implementation
Chronic Respiratory Questionnaire (CRQ)
Time frame: eight weeks after the program implementation
Medication adherence assessment with MARS-5
Time frame: eight weeks after the program implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary rehabilitation (PR) in people with COPD, run by Hawler Medical University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbation rate (time frame: eight weeks after the implementation of the program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.