BLOOD FLOW RESTRICTED RESISTANCE EXERCISES VERSUS LOW LEVEL LASER ON CARDIAC FUNCTIONS IN PATIENTS WITH CHRONIC HEART FAILURE (heart failure)

Cairo University (CU)

Status: Active, not recruiting

Conditions: Heart Failure NYHA Class II

Treatments: Other: Blood flow restricted resistance exercise:; Device: Acupuncture LLLT:; Drug: Medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07045038

Resis versus LLL heart failure

Details and patient eligibility

About

This study is designed to compare between blood flow restricted resistance exercises and low level laser on cardiac functions in patients with chronic heart failure

Full description

This study will be carried out on sixty male and female patients diagnosed with chronic heart failure. They will be recruited from El-Demerdash hospital, Ain Shams university, Cairo. Their ages will be ranged from (40-60) years old. The design of this study will be a randomized controlled trail (RCT).

The patients of this study will randomly assigned into three equal groups (n=20):

Study Group A (20 patients) will receive blood flow restricted resistance exercises in addition to medical treatment program and routine cardiac rehabilitation.

Study Group B (20 patients) will receive low level laser in addition to medical treatment program and routine cardiac rehabilitation.

Control Group C (20 patients) will receive medical treatment program and routine cardiac rehabilitation only.

The program of treatment for the three groups A ,B , and C will be applied once per day, three times per week for 12 consecutive weeks

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1- Sixty male and female patients diagnosed with chronic heart failure since six months with LVEF<40%.

  2- They are functionally classified as class II according to New York Heart Association (NYHA).

  3-Their age will be ranged from 40 to 60 years old. 4-Their BMI will be ranged from 25 to 29.9 kg/m². 5- They will have good mentality

Exclusion criteria

• • Unstable coronary heart disease. 2- Severe valvular diseases. 3- Underlying pulmonary disease (aspiration pneumonia, chronic obstructive pulmonary disease, pneumothorax, etc.).

  4- Inability to ambulate owing to physical problems (paresis induced by cerebral stroke, spinal cord injury, amputation, severe pain, dyspnea, etc.).

  5-muskloskletal problems (e.g. severe osteoarthritis or ankylosing spondylitis).

  6-impaired cognitive function (vascular dementia, Alzheimer's dementia, other psychological disease, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Acupuncture LLLT

Experimental group

Description:

This mode of therapy will be conducted for study group B as follows: A therapeutic unit (M6 MLS from ASA laser, Italy) with wavelength 905 nm, output 5-20 MW, laser beam spot size 0.785 cm2, energy density 91 J/cm2, energy delivered 28 J, and frequency 500HZ. Laser probe will be placed in intercostal space both anteriorly and posteriorly on chest wall. Each acupuncture point will be stimulated with a laser for 60 s, three weekly sessions over 12 successive weeks. Anterior chest wall acupuncture points are {LU1, LU2, CV17, (Ren17)}, posterior chest wall from a prone or setting position of the patient {UB13, (BL13), UB 17(BL17

Treatment:

Device: Acupuncture LLLT:

Blood flow restricted resistance exercise

Experimental group

Description:

The subject will warm up and cool down for at least five to seven minutes each, (before and after exercise). The patients will perform blood flow restricted resistance exercise (BFRRE) at 40-80% of 1RM with 50% limb occlusion pressure (LOP), while placing cuff on midthigh and perform four sets of bilateral knee extension exercise, each set consist of 15 repetitions with 30-60 second rest in between sets and relieve cuff pressure in rest period, three weekly sessions over 12 successive weeks

Treatment:

Other: Blood flow restricted resistance exercise:

Medical treatment and routine cardiac rehabilitation

Experimental group

Description:

All patients will enroll to maximum doses guideline medical treatment that include (Beta blockers-Aspocid- Ator-Concor-Tritace). Also all patients will adhere to routine cardiac rehabilitation: The patients will enroll in CR program for 12 weeks, three times per week for 12 week. Moderate-intensity treadmill exercise training achieving a target heart rate of 40-60% of HR reserve (calculated from pre-exercise symptom-limited treadmill exercise stress test by modified Bruce protocol). The duration of each session was 30- 45 minutes (5-10 minutes of treadmill warm up, followed by 20-30 minutes of aerobic continuous treadmill training and terminated by 5-10 minutes of cooling down). The patients will be monitor by continuous ECG monitoring, recording of blood pressure, and heart rate

Treatment:

Drug: Medical treatment