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

NCT06877130 | Completed

• 1 other identifier: P.T.REC/012/005597
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolic Syndrome X; Cardiovascular Problems in Elderly

Keywords

Metabolic Syndrome X; Blood Flow Restriction (BFR) Training Effects; Cardiovascular Functions in Elderly

Outcome Measures

Primary Outcomes (10)

• Weight and height measurement

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

  Baseline (assessment).

• 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.

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

• Pulse rate by Pulse oximeter

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

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

• 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.

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

• apolipoprotien test

  : test to detect the risk of cardiovascular disease

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

• 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

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

• 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.

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

• 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

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

• The double product (DP)

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

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

• 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)

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

Study Arms (2)

Group A (aerobic exercise with BFR group)

EXPERIMENTAL

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

Other: Aerobic exercise with BFR; Other: Aerobic training

Group B (aerobic training group)

ACTIVE COMPARATOR

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

Other: Aerobic training

Interventions

Aerobic exercise with BFR OTHER

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.

Group A (aerobic exercise with BFR group)

Aerobic training OTHER

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

Group A (aerobic exercise with BFR group); Group B (aerobic training group)

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Giza Governorate, 11432, Egypt

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Zeinab Mohamed Helmy, Professor of Physical Therapy

  Professor of Physical Therapy for Cardiovascular / Respiratory Disorders and Geriatrics Faculty of Physical Therapy Cairo University

  STUDY CHAIR

• Ebtesam Nabil Abdel Mohsen, Lecturer of Physical Therapy

  Lecturer of Physical Therapy for Cardiovascular / Respiratory Disorders and Geriatrics Faculty of Physical Therapy Cairo University

  STUDY DIRECTOR

• Yasser Abdel Monem Elhendy, Professor of Internal Medicine

  Professor of Internal Medicine Faculty of Medicine Zagazig University

  STUDY DIRECTOR

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: Assistant Lecturer

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 14, 2025
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 10, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)