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

NCT06956911 | Enrolling By Invitation

• 1 other identifier: P.T.REC\012\005679
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Post Coronary Artery Bypass Grafting

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

study group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

Traditional cardiac rehabilitation only

Device: traditional cardiac rehabilitation

Interventions

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

study group

traditional cardiac rehabilitation 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

control group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National heart institute

Cairo, Cairo Governorate, 3753450, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physical therapist

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 4, 2025
• Study Start: November 7, 2024
• Primary Completion: March 20, 2025
• Study Completion: June 15, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

EG (1)