Effect of Early Low Resisted Exercise With Blood Flow Restriction on Pulmonary Function in Post Cardiac Surgery Patient

NCT ID: NCT06956911

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-07
• Study Completion Date: 2025-06-15

Brief 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. 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

Conditions

Coronary Artery Bypass Grafting; Post Coronary Artery Bypass Grafting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

study group

Traditional cardiac rehabilitation with early low resisted exercise with blood flow restriction

Group Type: EXPERIMENTAL

traditional cardiac rehabilitation with early low resisted exercise with blood flow restriction

Intervention Type: DEVICE

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

control group

Traditional cardiac rehabilitation only

Group Type: ACTIVE_COMPARATOR

traditional cardiac rehabilitation

Intervention Type: DEVICE

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

Interventions

traditional cardiac rehabilitation with early low resisted exercise with blood flow restriction

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

Intervention Type: DEVICE

traditional cardiac rehabilitation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Still on mechanical ventilation more than 48 hours
• Neuromuscular diseases
• Rheumatoid arthritis
• Coagulopathy
• Chronic Obstructive Pulmonary Disease (COPD)
• Cardiac arrhythmias

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Toaa Mamdouh Makram

physical therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National heart institute

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

P.T.REC\012\005679

Identifier Type: -

Identifier Source: org_study_id