COPD Received PRNCT07020182
Efficacy Of Inpatient Pulmonary Rehabilitation Program In Elderly Patients With Acute Exacerbation Of COPD
A study testing physical therapy program in people with COPD Received PR and Elderly (People Aged 65 or More), run by Al-Azhar University at 1 site in Egypt.
Trial summary
The study aimed to identify the effect of early pulmonary rehabilitation in elderly patients with Acute exacerbation (AE) of COPD (AECOPD) in exercise tolerance, dyspnea, sleep quality, fatigue, and time to discharge from hospital. Read more about this study
- Who is it for?
- Ages 65 to 78 years
- Conditions the study is for
- COPD Received PR, Elderly (People Aged 65 or More), COPD
- What is being tested?
- physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2025to 15 Sep 2025
- 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 65 to 78 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with acute exacerbation of COPD in both gender
- Patient older than 65 years
- Patient with clear consciousness
- Patients had been diagnosed with shortness of breath or dyspnea that was not caused by heart disease, pneumothorax, or pulmonary edema
Who cannot join
- Patient with systolic blood pressure lower than 90 mmHg
- Patient with an unstable psychological status, hemoptysis, pneumothorax, pulmonary edema
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marwa Mohammed contact
Egypt1 site
Faculty of Medicine for Girls- Al-Azhar-University, Cairo, Egypt
Cairo, 02
About this study
The study aimed to identify the effect of early pulmonary rehabilitation in elderly patients with Acute exacerbation (AE) of COPD (AECOPD) in exercise tolerance, dyspnea, sleep quality, fatigue, and time to discharge from hospital.
Read the detailed description
A prospective supervised RCT (Randomized Controlled Trial) will be done include elderly COPD patients assigned randomly into two groups; Group A performed Physical therapy program, and Group B is control group completed two daily sessions from day 1 of hospital admission till discharge from the hospital .The study duration will be 12 weeks
- Being tested
- physical therapy program
- Keywords
- Elderly patients with acute exacerbation of 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.
physical therapy programOther
Group A will performed a physical therapy program that completed two daily sessions till discharge from the hospital .Exercise training starts from randomisation until hospital discharge,and administered twice per day, seven times per week. The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A will perform physical therapy program | Experimental | Study group In this study we will study the impact of exercise training include breathing exercise, low-load resistance exercise (15%-30% of 1 repetition maximum (1-RM) as tolerated), aerobic training in the form of walking exercise under supervision of physiotherapist.In patients exercise tolerance, dyspnea, fatigue, and time to discharge from hospital.
The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks Receives: Other: physical therapy program |
| Group B will the control group | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance
The 6 minute walk test(6MWT)in meter to asses exercise tolerance
Measured: The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks
Secondary outcomes (3)
Dyspnea
(The Modified Medical Research Council (mMRC )scale to assess Dyspnea)
Measured: The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks
Length of hospital stay(LOS)
(Number of days to assess length of stay in hospital (LOS) from admission to hospital to discharge from hospital)
Measured: The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks
Fatigue level
Fatigue Severity Scale (FSS)to assess fatigue)
Measured: The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start10 Jun 2025 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Received PRStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective supervised RCT (Randomized Controlled Trial) will be done include elderly COPD patients assigned randomly into two groups; Group A performed physical therapy program, and Group B is control group completed two daily sessions from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohammed, Al-Azhar University
- Investigators
- Mohammed, phd, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020182
- Sponsor's protocol ID
- INPATIENT COPD REHABILITATION
- Status last verified
- Jun 2025
- First submitted
- 10 May 2025
- Last updated
- 13 Jun 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 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Inpatient Pulmonary Rehabilitation Program In Elderly Patients With Acute Exacerbation Of COPD
- ClinicalTrials.gov ID
- NCT07020182
- Acronym / sponsor ID
- INPATIENT COPD REHABILITATION
- Keywords
- Elderly patients with acute exacerbation of COPD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 13 Jun 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.
The study aimed to identify the effect of early pulmonary rehabilitation in elderly patients with Acute exacerbation (AE) of COPD (AECOPD) in exercise tolerance, dyspnea, sleep quality, fatigue, and time to discharge from hospital.
Detailed description
A prospective supervised RCT (Randomized Controlled Trial) will be done include elderly COPD patients assigned randomly into two groups; Group A performed Physical therapy program, and Group B is control group completed two daily sessions from day 1 of hospital admission till discharge from the hospital .The study duration will be 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective supervised RCT (Randomized Controlled Trial) will be done include elderly COPD patients assigned randomly into two groups; Group A performed physical therapy program, and Group B is control group completed two daily sessions from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Group A will perform physical therapy program | Experimental | Other: physical therapy programStudy group In this study we will study the impact of exercise training include breathing exercise, low-load resistance exercise (15%-30% of 1 repetition maximum (1-RM) as tolerated), aerobic training in the form of walking exercise under supervision of physiotherapist.In patients exercise tolerance, dyspnea, fatigue, and time to discharge from hospital. The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks |
| Group B will the control group | No intervention | –control group |
Who may qualify
- Ages
- 65 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients with acute exacerbation of COPD in both gender
- Patient older than 65 years
- Patient with clear consciousness
- Patients had been diagnosed with shortness of breath or dyspnea that was not caused by heart disease, pneumothorax, or pulmonary edema
Key exclusion criteria (2 listed)
- Patient with systolic blood pressure lower than 90 mmHg
- Patient with an unstable psychological status, hemoptysis, pneumothorax, pulmonary edema
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 |
|---|---|---|
| physical therapy programGroup A will performed a physical therapy program that completed two daily sessions till discharge from the hospital .Exercise training starts from randomisation until hospital discharge,and administered twice per day, seven times per week. The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks | Other | Group A will perform physical therapy program |
Primary outcome
Exercise tolerance
Time frame: The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks
The 6 minute walk test(6MWT)in meter to asses exercise tolerance
3 secondary outcomes
Dyspnea
Time frame: The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks
Length of hospital stay(LOS)
Time frame: The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks
Fatigue level
Time frame: The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks
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 13 Jun 2025.
- Individual participant dataSharing planned: No
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.
Marwa Mohammed contact
Mohammed, phd principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy program in people with COPD Received PR and Elderly (People Aged 65 or More), run by Al-Azhar University at 1 site in Egypt.
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 2 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 13 Jun 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 Egypt. 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?
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?
Contact Marwa Mohammed, Phd -university lecturer (+201000253865, dr.marwamohammed@p.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise tolerance (time frame: The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks). 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 13 Jun 2025.