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Metabolic Syndrome XNCT06877130

Effect of Blood Flow Restriction on Cardiovascular Function in Elderly with Metabolic Syndrome X

A study testing Aerobic exercise with BFR and Aerobic training in people with Metabolic Syndrome X and Cardiovascular Problems in Elderly, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to investigate the effect of aerobic exercise with Blood flow restriction training (BFR) on cardiovascular function and quality of life in hypertensive elderly patients. Read more about this study

Who is it for?
Ages 60 to 70 years
What is being tested?
Aerobic exercise with BFR and Aerobic training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Jan 2024to 10 Feb 2025
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 60 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • sixty elderly patients.
  • Their ages will range from 60 to 70 years old.
  • Grade II Hypertensive patients (SBP 160-179 mmHg and/or DBP 100-109 mmHg)
  • Patients with dyslipidemia: at least one of the fasting lipid profile tests include the following results.
  • A-Total Cholestrol more than 240 (mg/dl). B-LDL Cholestrol more than 160 (mg/dl). C-HDL Cholestrol less than 40 (mg/dl). D-Triglycerides more than 200 (mg/dl).
  • 'Body Mass Index: from 30: 40 kg/m2 calss I and II obesity.

Who cannot join

  • Severe Chest diseases (either obstructive or restrictive).
  • Clinical signs of a severe cardiac event. (eg, severe atherosclerosis, congestive heart failure),
  • Severe psychiatric or cognitive impairment, who unable to follow comment.
  • Neurological disorders affecting respiratory muscles or any muscular dystrophies (cervical disc or bulge).
  • Patients with severe self-limiting illness (e.g., cancer).
  • Peripheral artery disease in lower extremities.
  • Systolic blood pressure < 180 mmHg, diastolic blood pressure more than 110 mmHg, or resting heart rate above 120 bpm.
  • Patient with uncontrolled - diabetes.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Physical Therapy, Cairo University

    Giza, Giza Governorate, 11432

Other trials in Egypt

About this study

The purpose of the study is to investigate the effect of aerobic exercise with Blood flow restriction training (BFR) on cardiovascular function and quality of life in hypertensive elderly patients.

Hypothesis There will be no significant effect of aerobic exercise with RBF on cardiovascular function and the quality of life in hypertensive elderly patients.

Read the detailed description

Sixty elderly patients with metabolic syndrome X aged from 65 to 75 years old. will be selected from Al-Ahrar teaching hospital -zagazig governorate.

Study Design:

This experimental comparative control study will be performed after patients' clinical assessment who will be randomly allocated into two equal groups:

Group A (aerobic exercise with BFR group):

Thirty patients will apply moderate aerobic exercise with RBF in form of a treadmill for 30 minutes for 12 weeks (3 sessions/ week).

Group B (aerobic training group):

Thirty patients will apply moderate intensity aerobic exercise without BFR for 30 minutes for 12 weeks (3 sessions/ weak).

Equipment:

A- Evaluative Equipment:

  1. Weight and height scale: (ZT-120 model, health scale made in china).
  2. Sphygmomanometer: (Model Number: GT001-110/111 aneroid sphygmomanometer, Zhejiang, China)
  3. Pulse oximeter: (Pulse Oximeter GRANZIA Model No: AS-304).
  4. Lab investigation: using blood sample to test the following factors A- Lipid Profile: Cobas Integra 400 Plus- Switzerland. B- Apolipoprotien: Cobas Integra 400 plus -Switzerland.
  5. Functional assessment: A-Timed Up and Go (TUG) Test The Timed Up and Go (TUG) test is a reliable, cost-effective, safe, and time-efficient way to evaluate overall functional mobility. B- Fatigue Assessment Scale (FAS): it is a way of measuring physical activity intensity level.
  6. Quality of life assessment by using HeartQoL questionnaire
  7. Treatment Equipment:
  8. Treadmill, (Model Grand Fit Ac 8885- china)
  9. BFR Training Therapy Occlusion Air Cuffs.

III) Procedures:

A- Evaluating Procedure:

History will be carefully taken to collect data about his general condition, physical therapy, and current medication.

The procedure of this study will be divided into the following main parts:

Preparatory procedure:

  1. All medical and demographic data of subjects will be collected. B. Vital signs will be measured to ensure that all subjects are medically stable.
  2. Recording data sheet: All data and information of each patient who participated in this study including name, age, address, weight, and height were recorded in the recording datasheet.
  3. Weight and height: A valid and reliable universal height and weight scale is used to determine the subjects' height and weight. Before treatment, each patient's height- and -weight were calculated to determine their body's mass index (BMI) using the following equation: BMI=weight (Kgs) /height (m2)
  4. Blood pressure monitoring by (Aneroid Sphygmomanometers) Aneroid sphygmomanometers were used to obtain a BP reading.
  5. Pulse rate by Pulse oximeter: It is widely used to noninvasively assess arterial oxyhemoglobin saturation (SpO2) and rate of heart (HR) during rest and activity.
  6. Lipid profile: All patients will perform laboratory lipid profile before and after the study. The three main blood levels collected to assess for dyslipidemia is (TG, HDL-C, LDL-C and T.G) after fasting for 8-12 hours. (Rosenson et al.2021).
  7. apolipoprotien test: test to detect the risk of cardiovascular disease
  8. Functioal assessment A-time up and go test: A sturdy armchair with a back was placed at the end of a hallway adjacent to where height and weight measures are routinely taken in the process of rooming participants. A piece of tape was placed on the floor 3 m away from the front edge of the chair. Patients were seated in the chair with back against the chair back, arms resting on the armrests, and given general instructions about the task, including walking at a normal rather than a rapid speed. The TUG required patients to stand up out of the chair, walk 3 m, turn around, walk back to the chair, and sit down. Patients were given the following instructions: "stand up on the word 'go,' walk to the tape, turn around, walk back to the chair, and sit down." The timing of the test began at the word "go," and ended when the participant was seated. B- Fatigue Assessment Scale (FAS) The FAS is a 10-item scale evaluating symptoms of chronic fatigue. In contrast to other similar measures the FAS treats fatigue as a unidimensional construct and does not separate its measurement into different factors. However, in order to ensure that the scale would evaluate all aspects of fatigue, developers chose items to represent both physical and mental symptoms. Each item of the FAS is answered using a five-point scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
  9. HeartQoL questionnaire. According to European Journal of Preventive Cardiology 2016 HeartQoL is a recently developed core health-related quality of life instrument for patients with coronary heart disease. The current study aims to investigate its association with patients' coronary risk profile and to provide reference values for patients with coronary heart disease (Appendix II).
  10. The double product (DP): consisting of the SBP multiplied by the pulse rate (PR), is an index of myocardial oxygen consumption.
  11. Mean Arterial Pressure:

The definition of mean arterial pressure (MAP) is the average arterial pressure throughout one cardiac cycle, systole, and diastole. MAP is influenced by cardiac output and systemic vascular resistance, each of which is influenced by several variables. (DeMers D et al 2023).

A common method used to estimate the MAP is the following formula:

  • MAP = DP + 1/3(SP - DP)
  1. Therapeutic procedure:
  • Aerobic exercise training
  1. Target heart rate: Maximum Heart Rate Formula: HR max = 206.9 - (0.67 x age) (Jackson et al., 2007). Moderate intensity aerobic exercise: the rate of heart reaches 64-76 percent of their age predicted peak hearty rate (American College of Sports Medicine et al. 2018).
  2. Determination of BFR To prescribe BFR training, Systolic blood pressure (SBP) will be measured using an automated oscillometer BP device

Blood pressure will be measured according to the recommendations of the American Heart Association. A bilateral restriction of 50% of the measured SBP will be applied to each lower limb for the application of BFR of lower limbs using the equipment. A wide cuff (18 cm wide) will be placed in the proximal portion of the thigh (inguinal fold region) and will be inflated until the absence of the tibial artery blood pulse. Thus, a 50% restriction of SBP will be applied in both legs during lower body exercises.

Being tested
Aerobic exercise with BFR, Aerobic training
Keywords
Metabolic Syndrome X, Blood Flow Restriction (BFR) Training Effects, Cardiovascular Functions in Elderly
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic exercise with BFROther

    To prescribe BFR training, Systolic blood pressure (SBP) will be measured using an automated oscillometer BP device.

    Blood pressure will be measured according to the recommendations of the American Heart Association. A bilateral restriction of 50% of the measured SBP will be applied to each lower limb for the application of BFR of lower limbs using the equipment. A wide cuff (18 cm wide) will be placed in the proximal portion of the thigh (inguinal fold region) and will be inflated until the absence of the tibial artery blood pulse. Thus, a 50% restriction of SBP will be applied in both legs during lower body exercises.

  • Aerobic trainingOther

    HR max = 206.9 - (0.67 x age).

    Moderate intensity aerobic exercise: the rate of heart reaches 64-76 percent of their age predicted peak hearty rate

Study groups in NCT06877130
Study groupRoleWhat they receive
Group A (aerobic exercise with BFR group)ExperimentalThirty patients will apply moderate aerobic exercise with RBF in form of a treadmill for 30 minutes for 12 weeks (3 sessions/ week).
Receives: Other: Aerobic exercise with BFR; Other: Aerobic training
Group B (aerobic training group)Active comparatorThirty patients will apply moderate intensity aerobic exercise without BFR for 30 minutes for 12 weeks (3 sessions/ weak).
Receives: Other: Aerobic training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight and height measurement

    Weight and height are recorded, and BMI will be calculated according to the formula: BMI = Weight (Kg) / Height (m2)

    Measured: Baseline (assessment).

  2. Blood pressure monitoring by (Aneroid Sphygmomanometers)

    Aneroid sphygmomanometers were used to obtain a BP reading (Pickering TG et al., 2005). Virtually 100% of the values. From the aneroid-device were within the three-mm-Hg range recommended' by the Association for the Advancement of Medical instrumentation.

    Measured: Baseline (assessment), and at 12 weeks post-intervention.

  3. Pulse rate by Pulse oximeter

    It is widely used to noninvasively assess arterial oxyhemoglobin saturation (SpO2).

    Measured: Baseline (assessment), and at 12 weeks post-intervention.

  4. Lipid profile

    All patients will perform laboratory lipid profile before and after the study. The three main blood levels collected to assess for dyslipidemia is (TG, HDL-C, LDL-C and T.G) after fasting for 8-12 hours.

    Measured: Baseline (assessment), and at 12 weeks post-intervention.

  5. apolipoprotien test

    : test to detect the risk of cardiovascular disease

    Measured: Baseline (assessment), and at 12 weeks post-intervention.

  6. time up and go test

    A sturdy armchair with a back was placed at the end of a hallway adjacent to where height and weight measures are routinely taken in the process of rooming participants.

    A piece of tape was placed on the floor 3 m away from the front edge of the chair. Patients were seated in the chair with back against the chair back, arms resting on the armrests, and given general instructions about the task, including walking at a normal rather than a rapid speed.

    The TUG required patients to stand up out of the chair, walk 3 m, turn around, walk back to the chair, and sit down. Patients were given the following instructions: "stand up on the word 'go,' walk to the tape, turn around, walk back to the chair, and sit down." The timing of the test began at the word "go," and ended when the participant was seated

    Measured: Baseline (assessment), and at 12 weeks post-intervention.

  7. Fatigue Assessment Scale

    The FAS is a 10-item scale evaluating symptoms of chronic fatigue. In contrast to other similar measures the FAS treats fatigue as a unidimensional construct and does not separate its measurement into different factors. However, in order to ensure that the scale would evaluate all aspects of fatigue, developers chose items to represent both physical and mental symptoms.

    Each item of the FAS is answered using a five-point scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.

    Measured: Baseline (assessment), and at 12 weeks post-intervention.

  8. HeartQoL questionnaire

    According to European Journal of Preventive Cardiology 2016 HeartQoL is a recently developed core health-related quality of life instrument for patients with coronary heart disease. The current study aims to investigate its association with patients' coronary risk profile and to provide reference values for patients with coronary heart disease

    Measured: Baseline (assessment), and at 12 weeks post-intervention.

  9. The double product (DP)

    consisting of the SBP multiplied by the pulse rate (PR), is an index of myocardial oxygen consumption

    Measured: Baseline (assessment), and at 12 weeks post-intervention.

  10. Mean Arterial Pressure

    The definition of mean arterial pressure (MAP) is the average arterial pressure throughout one cardiac cycle, systole, and diastole. MAP is influenced by cardiac output and systemic vascular resistance, each of which is influenced by several variables.

    A common method used to estimate the MAP is the following formula:

    MAP = DP + 1/3(SP - DP)

    Measured: Baseline (assessment), and at 12 weeks post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start1 Jan 2024
  3. Primary completion1 Dec 2024
  4. Study completion10 Feb 2025

Resources

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
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06877130
Sponsor's protocol ID
P.T.REC/012/005597
Status last verified
Mar 2025
First submitted
2 Mar 2025
Last updated
14 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise with BFR and Aerobic training in people with Metabolic Syndrome X and Cardiovascular Problems in Elderly, 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 6 inclusion and 8 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 14 Mar 2025. 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?

Weight and height measurement (time frame: Baseline (assessment).). The study lists 10 primary outcomes in all. 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 14 Mar 2025.

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