CopdNCT06142266
Functional Status in COPD Patients After Exercise Rehabilitation Program
A study testing Exercise rehabilitation program in people with Copd, run by Assiut University.
Trial summary
To evaluate the effectiveness of the exercise program in improving physical fitness and exercise capacity in COPD patients like walking distance, muscle strength, endurance will be measured before and after the program. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Copd
- What is being tested?
- Exercise rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of moderate-severe chronic obstructive pulmonary disease (COPD) based on spirometry results and clinical assessment.
- Age between 40 and 75 years. Stable disease status, defined as no exacerbations requiring admission to respiratory intensive care unit
- Willingness and ability to participate in a 12-week pulmonary rehabilitation program.
Who cannot join
- Presence of significant comorbidities or medical conditions that may interfere with participation in the pulmonary rehabilitation program (e.g., severe cardiovascular disease, musculoskeletal disorders, uncontrolled hypertension).
- Inability to perform the required exercise activities due to physical limitations or disabilities.
- Cognitive impairment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Improvement in Functional Status in Moderate to Severe Stable COPD Patients After Exercise Rehabilitation Program
To evaluate the effectiveness of the exercise program in improving physical fitness and exercise capacity in COPD patients like walking distance, muscle strength, endurance will be measured before and after the program.
To assess whether the program helps reduce COPD symptoms like shortness of breath and fatigue during daily activities. Quality of life questionnaires will be used.
Read the detailed description
Pulmonary rehabilitation is a comprehensive, multidisciplinary program that utilizes exercise training and patient education to improve the physical and psychological condition of people living with chronic respiratory diseases Exercise therapy and education work in an integrated manner to help patients better manage their condition.
Exercise therapy is a core component of pulmonary rehabilitation. Regular physical activity helps build endurance, strengthen respiratory muscles, and improve overall functional capacity . Both aerobic and resistance exercises are prescribed according to individual abilities and needs .Studies have shown exercise training can reduce symptoms, increase quality of life, and decrease healthcare utilization among pulmonary patients .Patient education teaches self-management skills like breathing techniques, medication management, coping strategies, and how to prevent or deal with exacerbations . Educating patients empowers them to better understand their condition and play an active role in their care. It also helps address anxiety and depression that often accompany chronic lung disease .
Recent reviews continue to support the benefits of pulmonary rehabilitation's holistic, exercise-education approach meta-analysis found multidisciplinary programs significantly improved outcomes such as hospital admissions compared to usual care . Additionally, study showed telerehabilitation with remote exercise monitoring and video classes achieved comparable benefits to traditional center-based programs . In summary, exercise therapy and education are core components of effective pulmonary rehabilitation
- Conditions
- Copd
- Being tested
- Exercise rehabilitation program
- 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.
Exercise rehabilitation programOther
This program will consist of twice-weekly supervised exercise sessions, including aerobic training and resistance exercises targeting the lower limbs for 12-week
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The intervention group (n=60) will undergo a 12-week pulmonary rehabilitation program. This program will consist of twice-weekly supervised exercise sessions, including aerobic training and resistance exercises targeting the lower limbs. Receives: Other: Exercise rehabilitation program |
| Control group | Active comparator | The control group (n=60) will receive usual medical care according to guidelines, which may include bronchodilator/anti-inflammatory therapy but no formal pulmonary rehabilitation. Receives: Other: Exercise rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in exercise capacity
Asess by Change in 6-minute walk distant
Measured: baseline
Secondary outcomes (1)
Health related quilt of life
Asess by St .George Questioner
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial conducted at Chest Department at Assiut University Hospital
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mohamed Sayed Mohamed, Assiut University
- Investigators
- Heba fahmy, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142266
- Sponsor's protocol ID
- COPD&Exercise rehabilitation
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gloeckl R, Schneeberger T, Jarosch I, Kenn K. Pulmonary Rehabilitation and Exercise Training in Chronic Obstructive Pulmonary Disease. Dtsch Arztebl Int. 2018 Feb 23;115(8):117-123. doi: 10.3238/arztebl.2018.0117.
PubMed 29526182Rutkowski S, Rutkowska A, Kiper P, Jastrzebski D, Racheniuk H, Turolla A, Szczegielniak J, Casaburi R. Virtual Reality Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Jan 13;15:117-124. doi: 10.2147/COPD.S223592. eCollection 2020.
PubMed 32021150
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Improvement in Functional Status in Moderate to Severe Stable COPD Patients After Exercise Rehabilitation Program
- ClinicalTrials.gov ID
- NCT06142266
- Acronym / sponsor ID
- COPD&Exercise rehabilitation
- Conditions
- Copd
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 21 Nov 2023 (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.
To evaluate the effectiveness of the exercise program in improving physical fitness and exercise capacity in COPD patients like walking distance, muscle strength, endurance will be measured before and after the program.
To assess whether the program helps reduce COPD symptoms like shortness of breath and fatigue during daily activities. Quality of life questionnaires will be used.
Detailed description
Pulmonary rehabilitation is a comprehensive, multidisciplinary program that utilizes exercise training and patient education to improve the physical and psychological condition of people living with chronic respiratory diseases Exercise therapy and education work in an integrated manner to help patients better manage their condition.
Exercise therapy is a core component of pulmonary rehabilitation. Regular physical activity helps build endurance, strengthen respiratory muscles, and improve overall functional capacity . Both aerobic and resistance exercises are prescribed according to individual abilities and needs .Studies have shown exercise training can reduce symptoms, increase quality of life, and decrease healthcare utilization among pulmonary patients .Patient education teaches self-management skills like breathing techniques, medication management, coping strategies, and how to prevent or deal with exacerbations . Educating patients empowers them to better understand their condition and play an active role in their care. It also helps address anxiety and depression that often accompany chronic lung disease .
Recent reviews continue to support the benefits of pulmonary rehabilitation's holistic, exercise-education approach meta-analysis found multidisciplinary programs significantly improved outcomes such as hospital admissions compared to usual care . Additionally, study showed telerehabilitation with remote exercise monitoring and video classes achieved comparable benefits to traditional center-based programs . In summary, exercise therapy and education are core components of effective pulmonary rehabilitation
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial conducted at Chest Department at Assiut University Hospital
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Exercise rehabilitation programThe intervention group (n=60) will undergo a 12-week pulmonary rehabilitation program. This program will consist of twice-weekly supervised exercise sessions, including aerobic training and resistance exercises targeting the lower limbs. |
| Control group | Active comparator | Other: Exercise rehabilitation programThe control group (n=60) will receive usual medical care according to guidelines, which may include bronchodilator/anti-inflammatory therapy but no formal pulmonary rehabilitation. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of moderate-severe chronic obstructive pulmonary disease (COPD) based on spirometry results and clinical assessment.
- Age between 40 and 75 years. Stable disease status, defined as no exacerbations requiring admission to respiratory intensive care unit
- Willingness and ability to participate in a 12-week pulmonary rehabilitation program.
Key exclusion criteria (3 listed)
- Presence of significant comorbidities or medical conditions that may interfere with participation in the pulmonary rehabilitation program (e.g., severe cardiovascular disease, musculoskeletal disorders, uncontrolled hypertension).
- Inability to perform the required exercise activities due to physical limitations or disabilities.
- Cognitive impairment
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 |
|---|---|---|
| Exercise rehabilitation programThis program will consist of twice-weekly supervised exercise sessions, including aerobic training and resistance exercises targeting the lower limbs for 12-week | Other | Control group, Intervention group |
Primary outcome
Improvement in exercise capacity
Time frame: baseline
Asess by Change in 6-minute walk distant
1 secondary outcome
Health related quilt of life
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 29526182Gloeckl R, Schneeberger T, Jarosch I, Kenn K. Pulmonary Rehabilitation and Exercise Training in Chronic Obstructive Pulmonary Disease. Dtsch Arztebl Int. 2018 Feb 23;115(8):117-123. doi: 10.3238/arztebl.2018.0117.
- Background: PubMed 32021150Rutkowski S, Rutkowska A, Kiper P, Jastrzebski D, Racheniuk H, Turolla A, Szczegielniak J, Casaburi R. Virtual Reality Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Jan 13;15:117-124. doi: 10.2147/COPD.S223592. eCollection 2020.
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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.
Heba fahmy, MD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise rehabilitation program 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hend saleh, MD (01098988712, hend.m.saleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in exercise capacity (time frame: baseline). 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 NCT06142266, which also lists 2 linked publications.
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 21 Nov 2023.