Heart Failure NYHA Class IIheart failureNCT07045038
Blood Flow Restricted Resistance Exercises Versus Low Level Laser on Cardiac Functions in Patients With Chronic Heart Failure
A study testing Acupuncture LLLT:, Blood flow restricted resistance exercise: and Medical treatment in people with Heart Failure NYHA Class II, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure NYHA Class II
- What is being tested?
- Acupuncture LLLT:, Blood flow restricted resistance exercise: and Medical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2025to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Heart Failure NYHA Class II
- Being tested
- Acupuncture LLLT:, Blood flow restricted resistance exercise:, Medical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)}.
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
Medical treatmentDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start20 Jul 2025
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure NYHA Class IIStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira Shukrey Shaffik Eshak, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045038
- Sponsor's protocol ID
- Resis versus LLL heart failure
- Acronym
- heart failure
- Status last verified
- Mar 2026
- First submitted
- 22 Jun 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) to maintain the confidentiality and privacy of the participants, as per the initial study protocol and ethical approvals
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restricted Resistance Exercises Versus Low Level Laser on Cardiac Functions in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT07045038
- Acronym / sponsor ID
- heart failure / Resis versus LLL heart failure
- Conditions
- Heart Failure NYHA Class II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Acupuncture LLLT | Experimental | 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 |
| Blood flow restricted resistance exercise | Experimental | Other: Blood 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 |
| routine cardiac rehabilitation | Experimental | Drug: Medical treatmentAll 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture 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)}. | Device | Acupuncture LLLT |
| Blood 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 | Other | Blood flow restricted resistance exercise |
| Medical treatmentAll 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 | Drug | routine cardiac rehabilitation |
Primary outcome
: speckle-tracking echocardiography - NO Blood analysis
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) to maintain the confidentiality and privacy of the participants, as per the initial study protocol and ethical approvals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture LLLT:, Blood flow restricted resistance exercise: and Medical treatment in people with Heart Failure NYHA Class II, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: speckle-tracking echocardiography - NO Blood analysis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.