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Completed

NCT Number: NCT06254586

Effects of Blood Flow Restriction Training on Exercises 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.

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Key information

Conditions

Health, Subjective

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic exercises

Procedure

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

Procedure

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.

Primary outcomes

  1. Heart rate

    Time frame: Baseline

    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.

  2. Heart rate

    Time frame: After 1 minute

    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.

  3. Heart rate

    Time frame: After 3 minutes

    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.

  4. Heart rate

    Time frame: After 5 minutes

    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.

  5. Heart rate

    Time frame: After 15 minutes

    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.

  6. Heart rate

    Time frame: After 30 minutes

    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.

  7. Blood pressure

    Time frame: Baseline

    BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

  8. Blood pressure

    Time frame: After 1 minute

    BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

  9. Blood pressure

    Time frame: After 3 minutes

    BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

  10. Blood pressure

    Time frame: After 5 minutes

    BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

  11. Blood pressure

    Time frame: After 15 minutes

    BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

  12. Blood pressure

    Time frame: After 30 minutes

    BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

  13. Mean arterial pressure

    Time frame: Baseline

    Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

  14. Mean arterial pressure

    Time frame: After 1 minute

    Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

  15. Mean arterial pressure

    Time frame: After 3 minutes

    Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

  16. Mean arterial pressure

    Time frame: After 5 minutes

    Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

  17. Mean arterial pressure

    Time frame: After 15 minutes

    Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

  18. Mean arterial pressure

    Time frame: After 30 minutes

    Mean arterial pressure monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.

  19. Muscle girth

    Time frame: Baseline

    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.

  20. Muscle girth

    Time frame: After 1 minute

    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.

  21. Muscle girth

    Time frame: After 3 minutes

    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.

  22. Muscle girth

    Time frame: After 5 minutes

    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.

  23. Muscle girth

    Time frame: After 15 minutes

    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.

  24. Muscle girth

    Time frame: After 30 minutes

    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.

Sponsors and collaborators

Lead sponsor

Prince Sattam Bin Abdulaziz University

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2024
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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