Blood Flow Restricted Resistance Exercises Versus Low Level Laser on Cardiac Functions in Patients With Chronic Heart Failure

NCT07045038 | Active Not Recruiting DMC

• 1 other identifier: Resis versus LLL heart failure
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure NYHA Class II

Outcome Measures

Primary Outcomes (1)

• : speckle-tracking echocardiography - NO Blood analysis

  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

  3 months

Study Arms (3)

Acupuncture LLLT

EXPERIMENTAL

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

Device: Acupuncture LLLT:

Blood flow restricted resistance exercise

EXPERIMENTAL

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

Other: Blood flow restricted resistance exercise:

routine cardiac rehabilitation

EXPERIMENTAL

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

Drug: Medical treatment

Interventions

Acupuncture LLLT: DEVICE

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)}.

Acupuncture LLLT

Medical treatment DRUG

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

routine cardiac rehabilitation

Blood flow restricted resistance exercise: OTHER

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

Blood flow restricted resistance exercise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assisstent

Model Details: 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

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 1, 2025
• Study Start: January 20, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)