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

Not Applicable

Active, not recruiting

• Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class II
• Interventions: Drug: Medical treatment

• Registration Number: NCT07045038
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2025-01-20
• Status Verified: 2025-06
• Study First Submitted: 2025-06-22
• Study First Submitted QC: 2025-06-22
• Last Update Submitted: 2025-06-22
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-04
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical treatment and routine cardiac rehabilitation	Medical 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). The patients will be monitor by continuous ECG monitoring, recording of blood pressure, and heart rate

Primary Outcome Measures

Name	Time	Method
: 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

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt