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Enrolling by Invitation

NCT Number: NCT06956911

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

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Key information

Conditions

Coronary Artery Bypass Grafting Post Coronary Artery Bypass Grafting

Age range

45 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National heart institute

Cairo, Cairo Governorate, 3753450, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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

  2. Hand grip strength

    Time frame: fourteen days

    measure hand grip strength by hand held dynamometer (digital apperatus) expressed by kilogram

  3. c-reactive protein lab

    Time frame: fourteen days

  4. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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