Coronary Artery Bypass GraftingNCT06956911
Effect of Early Low Resisted Exercise With Blood Flow Restriction on Pulmonary Function in Post Cardiac Surgery Patient
A study testing traditional cardiac rehabilitation with early low resisted exercise with blood flow restriction and traditional cardiac rehabilitation in people with Coronary Artery Bypass Grafting and Post Coronary Artery Bypass Grafting, run by Cairo University at 1 site in Egypt.
Trial summary
After cardiac surgery Patients present a loss of exercise capacity, muscle mass, and quality of life Cardiopulmonary rehabilitation aims to reduce the loss of muscle strength, size and increase cardiopulmonary function so that quality of life is maintained as much as possible after open-heart surgeries. Read more about this study
- Who is it for?
- Ages 45 to 60 years, men only
- Conditions the study is for
- Coronary Artery Bypass Grafting, Post Coronary Artery Bypass Grafting
- What is being tested?
- traditional cardiac rehabilitation with early low resisted exercise with blood flow restriction and traditional cardiac rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Nov 2024to 15 Jun 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 45 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patient aged from 45-60
- Elective open heart surgery via median sternotomy
- Post operative, extubated post open heart surgery, who can follow the instructions and sign the consent form
- Hemodynamic stability
- Neurological stability
Who cannot join
- Still on mechanical ventilation more than 48 hours
- Neuromuscular diseases
- Rheumatoid arthritis
- Coagulopathy
- Chronic Obstructive Pulmonary Disease (COPD)
- Cardiac arrhythmias
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
After cardiac surgery Patients present a loss of exercise capacity, muscle mass, and quality of life Cardiopulmonary rehabilitation aims to reduce the loss of muscle strength, size and increase cardiopulmonary function so that quality of life is maintained as much as possible after open-heart surgeries. Traditionally, cardiac rehabilitation consist of low-intensity aerobic exercise. Therefore, cardiac rehabilitation should include not only aerobic but also resistance training (RT),. A safe and effective version of RT is needed that can still improve muscle strength and size in patients early after cardiac surgery,It is found that BFR can achieve the same result with low intensity which is suitable for patient post cardiac surgery,so the result of this study will provide a safe resisted exercise useful for post cardiac surgery patient
- Being tested
- traditional cardiac rehabilitation with early low resisted exercise with blood flow restriction, traditional cardiac rehabilitation
- Keywords
- Post Coronary Artery Bypass Grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional cardiac rehabilitation with early low resisted exercise with blood flow restrictionDevice
Traditional cardiac rehabilitation and early low resisted exercise with 0.5 kilogram in form of bilateral upper limb exercise (elbow flexion and extension,wrist flexion and extension ) with external pressure applied with pressure cuff which determined by 40% of systolic blood pressure which applied on the proximal part of the arm,the frequency of exercise is once per day for 14 consecutive day and intensity determined by rate of perceived exertion scale
traditional cardiac rehabilitationDevice
Diaphragmatic and costal breathing exercise, active assisted to active range of motion,percussion,splinted cough,early mobility, upper limb exercise with breathing and incentive spirometer
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Traditional cardiac rehabilitation with early low resisted exercise with blood flow restriction Receives: Device: traditional cardiac rehabilitation with early low resisted exercise with blood flow restriction |
| control group | Active comparator | Traditional cardiac rehabilitation only Receives: Device: traditional cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary function test, parameters that be measured is FVC and will be expressed as % of the predicted value for age,height,weight and sex and FEV1 and will be expressed as % of the predicted value of age ,sex,weight and height
parameters that be measured is FVC and will be expressed as % of the predicted value for age, height ,weight and sex and FEV1 and will be expressed as % of the predicted value of age ,sex, weight and height
Measured: fourteen days
Hand grip strength
measure hand grip strength by hand held dynamometer (digital apperatus) expressed by kilogram
Measured: fourteen days
c-reactive protein lab
Measured: fourteen days
Functional capacity
measure functional capacity by six minute walk test by calculate the total distance covered by the patient expressed by meters
Measured: fourteen days ,first measure will be at the session of assessment and last measure will be at the end of treatment program after fourteen days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start7 Nov 2024
- Primary completion20 Mar 2025
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toaa Mamdouh Makram, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956911
- Sponsor's protocol ID
- P.T.REC\012\005679
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Low Resisted Exercise With Blood Flow Restriction on Pulmonary Function in Post Cardiac Surgery Patient
- ClinicalTrials.gov ID
- NCT06956911
- Acronym / sponsor ID
- P.T.REC\012\005679
- Keywords
- Post Coronary Artery Bypass Grafting
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 4 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.
After cardiac surgery Patients present a loss of exercise capacity, muscle mass, and quality of life Cardiopulmonary rehabilitation aims to reduce the loss of muscle strength, size and increase cardiopulmonary function so that quality of life is maintained as much as possible after open-heart surgeries. Traditionally, cardiac rehabilitation consist of low-intensity aerobic exercise. Therefore, cardiac rehabilitation should include not only aerobic but also resistance training (RT),. A safe and effective version of RT is needed that can still improve muscle strength and size in patients early after cardiac surgery,It is found that BFR can achieve the same result with low intensity which is suitable for patient post cardiac surgery,so the result of this study will provide a safe resisted exercise useful for post cardiac surgery patient
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: traditional cardiac rehabilitation with early low resisted exercise with blood flow restrictionTraditional cardiac rehabilitation with early low resisted exercise with blood flow restriction |
| control group | Active comparator | Device: traditional cardiac rehabilitationTraditional cardiac rehabilitation only |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male patient aged from 45-60
- Elective open heart surgery via median sternotomy
- Post operative, extubated post open heart surgery, who can follow the instructions and sign the consent form
- Hemodynamic stability
- Neurological stability
Key exclusion criteria (6 listed)
- Still on mechanical ventilation more than 48 hours
- Neuromuscular diseases
- Rheumatoid arthritis
- Coagulopathy
- Chronic Obstructive Pulmonary Disease (COPD)
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 |
|---|---|---|
| traditional cardiac rehabilitation with early low resisted exercise with blood flow restrictionTraditional cardiac rehabilitation and early low resisted exercise with 0.5 kilogram in form of bilateral upper limb exercise (elbow flexion and extension,wrist flexion and extension ) with external pressure applied with pressure cuff which determined by 40% of systolic blood pressure which applied on the proximal part of the arm,the frequency of exercise is once per day for 14 consecutive day and intensity determined by rate of perceived exertion scale | Device | study group |
| traditional cardiac rehabilitationDiaphragmatic and costal breathing exercise, active assisted to active range of motion,percussion,splinted cough,early mobility, upper limb exercise with breathing and incentive spirometer | Device | control group |
Primary outcome
pulmonary function test, parameters that be measured is FVC and will be expressed as % of the predicted value for age,height,weight and sex and FEV1 and will be expressed as % of the predicted value of age ,sex,weight and height
Time frame: fourteen days
parameters that be measured is FVC and will be expressed as % of the predicted value for age, height ,weight and sex and FEV1 and will be expressed as % of the predicted value of age ,sex, weight and height
Hand grip strength
Time frame: fourteen days
measure hand grip strength by hand held dynamometer (digital apperatus) expressed by kilogram
c-reactive protein lab
Time frame: fourteen days
Functional capacity
Time frame: fourteen days ,first measure will be at the session of assessment and last measure will be at the end of treatment program after fourteen days
measure functional capacity by six minute walk test by calculate the total distance covered by the patient expressed by meters
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 4 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional cardiac rehabilitation with early low resisted exercise with blood flow restriction and traditional cardiac rehabilitation in people with Coronary Artery Bypass Grafting and Post Coronary Artery Bypass Grafting, run by Cairo 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 5 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: enrolling by invitation, as of the sponsor's last update on 4 May 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?
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?
pulmonary function test, parameters that be measured is FVC and will be expressed as % of the predicted value for age,height,weight and sex and FEV1 and will be expressed as % of the predicted value of age ,sex,weight and height (time frame: fourteen days). The study lists 4 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 4 May 2025.