COPDNCT07197229
Hospital- and Home-Based Structured Pulmonary Rehabilitation in Recently Admitted COPD Patients: A Quasi-Experimental Study at Assiut University
A study testing Pulmonary Rehabilitation in people with COPD, run by Assiut University.
Trial summary
This study evaluates the effect of a structured three-month pulmonary rehabilitation (PR) program, delivered both in-hospital and at home, on exercise capacity, respiratory symptoms, and functional status in stable COPD patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable COPD patients diagnosed based on spirometry (post-bronchodilator FEV1/FVC <70%)
- Age > 40 years
- Moderate to severe COPD stage
- Able and willing to participate in rehabilitation program
Who cannot join
- Age < 40 years
- Current acute COPD exacerbation at enrollment
- Significant comorbid conditions limiting participation (e.g., uncontrolled diabetes mellitus, uncontrolled hypertension, left-sided heart failure, renal failure, liver cell failure)
- Neuromuscular diseases, severe cognitive impairment, or psychiatric disturbance
- Pregnant patients
- Unwilling to participate in the rehabilitation program
About this study
Official title: Evaluation of Three Months Combined Hospital and Home-Based Tailored Rehabilitation Program in COPD Patients Recently Admitted to Chest Department of Assiut University Hospital
This study evaluates the effect of a structured three-month pulmonary rehabilitation (PR) program, delivered both in-hospital and at home, on exercise capacity, respiratory symptoms, and functional status in stable COPD patients.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of mortality and morbidity worldwide, significantly reducing patients' physical activity and quality of life. This study investigates a tailored pulmonary rehabilitation program combining hospital-based and home-based components over 12 weeks. The hospital component includes patient education, nutritional support, structured exercise training for both upper and lower limbs, and smoking cessation strategies. The home program emphasizes continuity with daily walking, strength exercises, and lifestyle modifications. The program aims to improve exercise capacity, dyspnea scores, and quality of life. Assessments include the six-minute walk test (6MWT), CAT score, mMRC dyspnea scale, spirometry, arterial blood gas analysis, and the St George's Respiratory Questionnaire. Measurements are collected at baseline and after program completion to assess improvements.
- Conditions
- COPD
- Being tested
- Pulmonary Rehabilitation
- Keywords
- COPD
- 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 RehabilitationBehavioural
A tailored pulmonary rehabilitation program combining hospital-based and home-based components over 12 weeksParticipants undergo a 12-week structured PR program including both hospital-based sessions (education, structured exercise, nutrition counseling, smoking cessation) and home-based exercises (daily walking, strength training progression
| Study group | Role | What they receive |
|---|---|---|
| patients diagnosed with moderate-to-severe COPD (confirmed by spirometry) who are clinically stable | Experimental | Participants undergo a 12-week structured PR program including both hospital-based sessions (education, structured exercise, nutrition counseling, smoking cessation) and home-based exercises (daily walking, strength training progression). Receives: Behavioral: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test (6MWT)
Measures the distance (in meters) a patient can walk in six minutes as a marker of exercise capacity and functional endurance.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start30 Apr 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- ince this is a quasi-experimental single-arm study, there is only one intervention group the Pulmonary Rehabilitation Group: Participants undergo a 12-week structured PR program including both hospital-based sessions (education, structured exercise, nutrition counseling, smoking cessation) and home-based exercises (daily walking, strength training progression).
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taghreed Essam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197229
- Sponsor's protocol ID
- Combined Pulmonary Rehabilitat
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arnold MT, Dolezal BA, Cooper CB. Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease: Highly Effective but Often Overlooked. Tuberc Respir Dis (Seoul). 2020 Oct;83(4):257-267. doi: 10.4046/trd.2020.0064. Epub 2020 Aug 10.
PubMed 32773722
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Three Months Combined Hospital and Home-Based Tailored Rehabilitation Program in COPD Patients Recently Admitted to Chest Department of Assiut University Hospital
- ClinicalTrials.gov ID
- NCT07197229
- Acronym / sponsor ID
- Combined Pulmonary Rehabilitat
- Conditions
- COPD
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Sep 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 study evaluates the effect of a structured three-month pulmonary rehabilitation (PR) program, delivered both in-hospital and at home, on exercise capacity, respiratory symptoms, and functional status in stable COPD patients.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of mortality and morbidity worldwide, significantly reducing patients' physical activity and quality of life. This study investigates a tailored pulmonary rehabilitation program combining hospital-based and home-based components over 12 weeks. The hospital component includes patient education, nutritional support, structured exercise training for both upper and lower limbs, and smoking cessation strategies. The home program emphasizes continuity with daily walking, strength exercises, and lifestyle modifications. The program aims to improve exercise capacity, dyspnea scores, and quality of life. Assessments include the six-minute walk test (6MWT), CAT score, mMRC dyspnea scale, spirometry, arterial blood gas analysis, and the St George's Respiratory Questionnaire. Measurements are collected at baseline and after program completion to assess improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ince this is a quasi-experimental single-arm study, there is only one intervention group the Pulmonary Rehabilitation Group: Participants undergo a 12-week structured PR program including both hospital-based sessions (education, structured exercise, nutrition counseling, smoking cessation) and home-based exercises (daily walking, strength training progression).
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed with moderate-to-severe COPD (confirmed by spirometry) who are clinically stable | Experimental | Behavioral: Pulmonary RehabilitationParticipants undergo a 12-week structured PR program including both hospital-based sessions (education, structured exercise, nutrition counseling, smoking cessation) and home-based exercises (daily walking, strength training progression). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable COPD patients diagnosed based on spirometry (post-bronchodilator FEV1/FVC <70%)
- Age > 40 years
- Moderate to severe COPD stage
- Able and willing to participate in rehabilitation program
Key exclusion criteria (6 listed)
- Age < 40 years
- Current acute COPD exacerbation at enrollment
- Significant comorbid conditions limiting participation (e.g., uncontrolled diabetes mellitus, uncontrolled hypertension, left-sided heart failure, renal failure, liver cell failure)
- Neuromuscular diseases, severe cognitive impairment, or psychiatric disturbance
- Pregnant patients
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 RehabilitationA tailored pulmonary rehabilitation program combining hospital-based and home-based components over 12 weeksParticipants undergo a 12-week structured PR program including both hospital-based sessions (education, structured exercise, nutrition counseling, smoking cessation) and home-based exercises (daily walking, strength training progression | Behavioural | patients diagnosed with moderate-to-severe COPD (confirmed by spirometry) who are clinically stable |
Primary outcome
Six-Minute Walk Test (6MWT)
Time frame: 12 weeks
Measures the distance (in meters) a patient can walk in six minutes as a marker of exercise capacity and functional endurance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Background: PubMed 32773722Arnold MT, Dolezal BA, Cooper CB. Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease: Highly Effective but Often Overlooked. Tuberc Respir Dis (Seoul). 2020 Oct;83(4):257-267. doi: 10.4046/trd.2020.0064. Epub 2020 Aug 10.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with COPD, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Six-Minute Walk Test (6MWT) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07197229, which also lists 1 linked publication.
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 29 Sep 2025.