Clinical trial NCT06254586: Effects of Blood Flow Restriction Training on Exercises in Healthy Individuals.
Official title: Effects of Blood Flow Restriction Training on Heart Rate, Blood Pressure, Mean Arterial Pressure, and Limb Girth During Resisted Exercises Versus Aerobic Exercise in Healthy Individuals.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health, Subjective
Keywords: Blood flow Restriction Training
Blood Pressure
Heart Rate
Mean Arterial Pressure
Muscle Girth
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Partial restriction of blood flow to working muscles during exercise is proven to increase muscle mass and strength even with low-intensity of exercise. Blood Flow Restriction Training (BFRT) is also beneficial to improve the maximum rate of oxygen consumption (VO2max), bone health, and vascular health. Recent studies focus on its effects beyond the musculoskeletal system. Post-exercise hypotension is a known acute physiological response that happens after intense exercise. Early studies demonstrated BFRT might amplify the acute hypotensive effects with low intensity of exercise. However, it's not clear what type of exercise would help to lower blood pressure when it is combined with BFRT.

Detailed description: Partial restriction of blood flow to working muscles during exercise is proven to increase muscle mass and strength even with low-intensity of exercise. Blood Flow Restriction Training (BFRT) is also beneficial to improve the maximum rate of oxygen consumption (VO2max), bone health, and vascular health. Recent studies focus on its effects beyond the musculoskeletal system. Post-exercise hypotension is a known acute physiological response that happens after intense exercise. Early studies demonstrated BFRT might amplify the acute hypotensive effects with low intensity of exercise. However, it's not clear what type of exercise would help to lower blood pressure when it is combined with BFRT. Considering BFRT, it's safe to implement among hypertensive individuals as per recent studies. It's still unclear what type of exercise would benefit maximum in reducing blood pressure while using it along BFR. The study aims to determine whether BFRT can influence BP, MAP, HR, and muscle girth differently while doing resisted exercises and aerobic exercise. Understanding the effects of BFRT on these parameters can provide valuable insights for optimizing exercise protocols and improving overall health outcomes. In general, this study can also add to the increasing amount of studies about the possible advantages and drawbacks of BFRT, and provide guidance on how to design exercise programs for people with borderline hypertension or in those with early phase of hypertension.

Eligibility criteria: Inclusion Criteria:

* Healthy adults of both gender, between the ages of 18 and 35 years
* Adults who are not participating in any regular exercise/fitness programmes for the last three months

Exclusion Criteria:

* Adults with previous history of cardiovascular diseases, or with pathological changes in ECG
* Adults with concomitant illness such as diabetes, hypertension, or kidney diseases
* Chronic smokers or alcoholics
* Those with recent history of injury to lower limbs or with implants in lower limbs

Primary outcomes:
measure: Heart rate
timeFrame: Baseline
measure: Heart rate
timeFrame: After 1 minute
measure: Heart rate
timeFrame: After 3 minutes
measure: Heart rate
timeFrame: After 5 minutes
measure: Heart rate
timeFrame: After 15 minutes
measure: Heart rate
timeFrame: After 30 minutes
measure: Blood pressure
timeFrame: Baseline
measure: Blood pressure
timeFrame: After 1 minute
measure: Blood pressure
timeFrame: After 3 minutes
measure: Blood pressure
timeFrame: After 5 minutes
measure: Blood pressure
timeFrame: After 15 minutes
measure: Blood pressure
timeFrame: After 30 minutes
measure: Mean arterial pressure
timeFrame: Baseline
measure: Mean arterial pressure
timeFrame: After 1 minute
measure: Mean arterial pressure
timeFrame: After 3 minutes
measure: Mean arterial pressure
timeFrame: After 5 minutes
measure: Mean arterial pressure
timeFrame: After 15 minutes
measure: Mean arterial pressure
timeFrame: After 30 minutes
measure: Muscle girth
timeFrame: Baseline
measure: Muscle girth
timeFrame: After 1 minute
measure: Muscle girth
timeFrame: After 3 minutes
measure: Muscle girth
timeFrame: After 5 minutes
measure: Muscle girth
timeFrame: After 15 minutes
measure: Muscle girth
timeFrame: After 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Gopal Nambi
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Gopal Nambi, PhD
role: PRINCIPAL_INVESTIGATOR
References: