Health, SubjectiveNCT06254586
Effects of Blood Flow Restriction Training on Exercises in Healthy Individuals.
A study testing Aerobic exercises and Resisted exercises in people with Health, Subjective, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- Aerobic exercises and Resisted exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Apr 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Health, Subjective
- Being tested
- Aerobic exercises, Resisted exercises
- Keywords
- Blood flow Restriction Training, Blood Pressure, Heart Rate, Mean Arterial Pressure, Muscle Girth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercisesProcedure or surgery
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 exercisesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | This group received a single session of low-intensity cycling for 20 minutes. Receives: Procedure: Aerobic exercises |
| Resisted exercises | Active comparator | 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. Receives: Procedure: Resisted exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 30 minutes
Blood pressure
BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.
Measured: Baseline
Blood pressure
BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.
Measured: After 1 minute
Blood pressure
BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.
Measured: After 3 minutes
Blood pressure
BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.
Measured: After 5 minutes
Blood pressure
BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.
Measured: After 15 minutes
Blood pressure
BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Apr 2022
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gopal Nambi, Prince Sattam Bin Abdulaziz University
- Investigators
- Gopal Nambi, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254586
- Sponsor's protocol ID
- THIAGU 01
- Status last verified
- Feb 2024
- First submitted
- 3 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06254586
- Acronym / sponsor ID
- THIAGU 01
- Conditions
- Health, Subjective
- Keywords
- Blood flow Restriction Training, Blood Pressure, Heart Rate, Mean Arterial Pressure, Muscle Girth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Procedure: Aerobic exercisesThis group received a single session of low-intensity cycling for 20 minutes. |
| Resisted exercises | Active comparator | Procedure: Resisted exercisesThis 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercisesThis 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. | Procedure or surgery | Aerobic exercise |
| Resisted exercisesThis 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. | Procedure or surgery | Resisted exercises |
Primary outcome
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.
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.
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.
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.
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.
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.
Blood pressure
Time frame: Baseline
BP monitor devices use an inflatable cuff to measure blood pressure and detect pulsations to determine the heart rate.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gopal Nambi, PhD principal investigator
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercises and Resisted exercises in people with Health, Subjective, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: Baseline). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.