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

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 Overview

• Status: Enrolling by invitation
• Conditions: Coronary Artery Bypass Grafting; Post Coronary Artery Bypass Grafting
• Intervention / Treatment: Device: traditional cardiac rehabilitation with early low resisted exercise with blood flow restriction; Device: traditional cardiac rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 3753450
    • National Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; Traditional cardiac rehabilitation with early low resisted exercise with blood flow restriction	Device: 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
Active Comparator: control group; Traditional cardiac rehabilitation only	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	fourteen days
Hand grip strength	measure hand grip strength by hand held dynamometer (digital apperatus) expressed by kilogram	fourteen days
c-reactive protein lab		fourteen days
Functional capacity	measure functional capacity by six minute walk test by calculate the total distance covered by the patient expressed by meters	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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Actual): March 20, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Post Coronary Artery Bypass Grafting
• Other Study ID Numbers: P.T.REC\012\005679

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No