Effects of Blood Flow Restriction Training on Exercises in Healthy Individuals.

Health, Subjective Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06254586
• Other study ID #: THIAGU 01
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: February 2024
• Source: Prince Sattam Bin Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Health, Subjective

Intervention

Procedure:
• Aerobic exercises
This group received a single session of low-intensity cycling for 20 minutes. A period of reperfusion (3 to 5 minutes) were provided in both groups after 10 minutes of exercise training by deflating the BFR cuffs. The cuffs were inflated after 5 minutes of reperfusion, and the exercises were completed in both groups.
• Resisted exercises
This group received four sets of 15 repetitions of knee extension, hamstring curls, and standing calf raises (20-40% 1RM) with 30 sec to 1 minute rest period between sets. A period of reperfusion (3 to 5 minutes) were provided in both groups after 10 minutes of exercise training by deflating the BFR cuffs. The cuffs were inflated after 5 minutes of reperfusion, and the exercises were completed in both groups.

Locations

Country	Name	City	State
Saudi Arabia	Gopal Nambi	Al Kharj	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	The chest strap heart rate monitors can continuously monitor heart rate throughout the day. These devices use optical sensors or electrodes to detect changes in blood flow and provide real-time data.	Baseline
Primary	Heart rate	The chest strap heart rate monitors can continuously monitor heart rate throughout the day. These devices use optical sensors or electrodes to detect changes in blood flow and provide real-time data.	After 1 minute
Primary	Heart rate	The chest strap heart rate monitors can continuously monitor heart rate throughout the day. These devices use optical sensors or electrodes to detect changes in blood flow and provide real-time data.	After 3 minutes
Primary	Heart rate	The chest strap heart rate monitors can continuously monitor heart rate throughout the day. These devices use optical sensors or electrodes to detect changes in blood flow and provide real-time data.	After 5 minutes
Primary	Heart rate	The chest strap heart rate monitors can continuously monitor heart rate throughout the day. These devices use optical sensors or electrodes to detect changes in blood flow and provide real-time data.	After 15 minutes
Primary	Heart rate	The chest strap heart rate monitors can continuously monitor heart rate throughout the day. These devices use optical sensors or electrodes to detect changes in blood flow and provide real-time data.	After 30 minutes
Primary	Blood pressure	BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	Baseline
Primary	Blood pressure	BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 1 minute
Primary	Blood pressure	BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 3 minutes
Primary	Blood pressure	BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 5 minutes
Primary	Blood pressure	BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 15 minutes
Primary	Blood pressure	BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 30 minutes
Primary	Mean arterial pressure	Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	Baseline
Primary	Mean arterial pressure	Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 1 minute
Primary	Mean arterial pressure	Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 3 minutes
Primary	Mean arterial pressure	Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 5 minutes
Primary	Mean arterial pressure	Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 15 minutes
Primary	Mean arterial pressure	Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 30 minutes
Primary	Muscle girth	For biceps measurement, the individual should flex their arm at a 90-degree angle.; Place the tape measure around the midpoint of the upper arm, making sure it is snug but not tight.; Record the measurement in inches or centimeters.	Baseline
Primary	Muscle girth	For biceps measurement, the individual should flex their arm at a 90-degree angle.; Place the tape measure around the midpoint of the upper arm, making sure it is snug but not tight.; Record the measurement in inches or centimeters.	After 1 minute
Primary	Muscle girth	For biceps measurement, the individual should flex their arm at a 90-degree angle.; Place the tape measure around the midpoint of the upper arm, making sure it is snug but not tight.; Record the measurement in inches or centimeters.	After 3 minutes
Primary	Muscle girth	For biceps measurement, the individual should flex their arm at a 90-degree angle.; Place the tape measure around the midpoint of the upper arm, making sure it is snug but not tight.; Record the measurement in inches or centimeters.	After 5 minutes
Primary	Muscle girth	For biceps measurement, the individual should flex their arm at a 90-degree angle.; Place the tape measure around the midpoint of the upper arm, making sure it is snug but not tight.; Record the measurement in inches or centimeters.	After 15 minutes
Primary	Muscle girth	For biceps measurement, the individual should flex their arm at a 90-degree angle.; Place the tape measure around the midpoint of the upper arm, making sure it is snug but not tight.; Record the measurement in inches or centimeters.	After 30 minutes