Heart Failure NYHA Class II
Conditions
Brief summary
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
Detailed 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
Interventions
DEVICEAcupuncture LLLT:
Acupuncture LLLT: 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)}.
OTHERBlood flow restricted resistance exercise:
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
DRUGMedical treatment
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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3 group of Heart failure patients 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
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Sixty male and female patients diagnosed with chronic heart failure since six months with LVEF\<40%. * They are functionally classified as class II according to New York Heart Association (NYHA). * Their age will be ranged from 40 to 60 years old. * Their BMI will be ranged from 25 to 29.9 kg/m². * They will have good mentality
Exclusion criteria
* Unstable coronary heart disease. * Severe valvular diseases. * Underlying pulmonary disease (aspiration pneumonia, chronic obstructive pulmonary disease, pneumothorax, etc.). * Inability to ambulate owing to physical problems (paresis induced by cerebral stroke, spinal cord injury, amputation, severe pain, dyspnea, etc.). * muskloskletal problems (e.g. severe osteoarthritis or ankylosing spondylitis). * impaired cognitive function (vascular dementia, Alzheimer's dementia, other psychological disease, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| : speckle-tracking echocardiography - NO Blood analysis | 3 months | Echocardiography: speckle-tracking echocardiography an advanced, non invasive imaging modality that allow accurate assessment of the global and regional function of both atrial and ventricular chambers based on interaction between myocardial tissue and ultrasound beam. It is possible to obtain the deformation of LV myocardium along longitudinal, circumferential, radial and rotational plane. As longitudinal strain (LS) represents the LV myocardial shortening along its longitudinal axis. Radial strain (RS) reflect radial myocardial deformation corresponding to systolic thickening and is defined by positive curve. Circumferential strain (CR) represents the myocardial shortening along the circumferential plane, normally curves are negative. NO Blood analysis: All blood samples will be collected by venipuncture and immediately will be analyzed with Nitric Oxide Assay Kit (Fluorometric). The Kit is used to measure NO concentration |
Countries
Egypt
Outcome results
None listed