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

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.

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.

Study Overview

• Status: Completed
• Conditions: Health, Subjective
• Intervention / Treatment: Procedure: Aerobic exercises; Procedure: Resisted exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al Kharj, Riyadh, Saudi Arabia, 11942
      • Gopal Nambi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic exercise; This group received a single session of low-intensity cycling for 20 minutes.	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.
Active Comparator: Resisted exercises; This group received four sets of 15 repetitions of knee extension, hamstring curls, and standing calf raises (20-40% 1RM) with a 30 sec to 1 minute rest period between sets.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Blood pressure	BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	Baseline
Blood pressure	BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 1 minute
Blood pressure	BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 3 minutes
Blood pressure	BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 5 minutes
Blood pressure	BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 15 minutes
Blood pressure	BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.	After 30 minutes
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Prince Sattam Bin Abdulaziz University
• Investigators: Principal Investigator: Gopal Nambi, PhD, Prince Sattam Bin Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: February 3, 2024
• First Submitted That Met QC Criteria: February 3, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Blood Pressure; Heart Rate; Mean Arterial Pressure; Blood flow Restriction Training; Muscle Girth
• Other Study ID Numbers: THIAGU 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No