HealthyNCT05145335
Perceptual, Hemodynamic and Cardiovascular Responses of Two Different BFR Training Protocols
A study testing Autoregulated Blood Flow Restriction Cuff (smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training and Non-autoregulated blood flow restriction cuff ((smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training) in people with Healthy, run by University Ghent at 1 site in Belgium.
Trial summary
BFR training is growing in popularity and a variety of devices are on the market for clinical use. One way in which it is thought that BFR resistance training safety can be increased is by using a BFR cuff that regulates the applied pressure to the limb during each repetition. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Autoregulated Blood Flow Restriction Cuff (smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training and Non-autoregulated blood flow restriction cuff ((smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Oct 2021to 3 Apr 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants
- Be motivated to visit Ghent University Hospital 5 times for 30 minutes
Who cannot join
- Suffering from a neuromuscular disease, affecting lower limbs
- Reduced functioning or pain in the dominant leg
- Taking pain medication
- Previous cardiovascular surgery affecting lower limbs
- Symptomatic cardiovascular or hemodynamic suffering
- Pregnant
- Increased risk for DVT (genetic or history of)
- Not being able to perform physical activities, for whatever (medical) reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perceptual, Hemodynamic and Cardiovascular Responses of Two Different BFR Training Protocols Using Either an Autoregulated Pressure or a Non-autoregulated Pressure
BFR training is growing in popularity and a variety of devices are on the market for clinical use. One way in which it is thought that BFR resistance training safety can be increased is by using a BFR cuff that regulates the applied pressure to the limb during each repetition. This is thought to reduce perceptual, hemodynamic and cardiovascular responses to non-autoregulated approaches, theoretically increasing long-term compliance and safety with BFR training.
Read the detailed description
BFR training is growing in popularity and a variety of devices are on the market for clinical use. One way in which it is thought that BFR resistance training safety can be increased is by using a BFR cuff that regulates the applied pressure to the limb during each repetition. This is thought to reduce perceptual, hemodynamic and cardiovascular responses to non-autoregulated approaches, theoretically increasing long-term compliance and safety with BFR training.
However, only one study has directly compared the effect of an autoregulated vs. non-autoregulated and their design did not standardize the cuff width between the autoregulated and the non-autoregulated cuff, potentially leading to differences in observed outcomes. That study concluded that autoregulated cuffs better manage the hemodynamic and perceptual responses to non-failure training protocols while providing a more accurate cuff-limb interface pressure, thus increasing safety profile. Moreover, BFR resistance training is commonly performed to failure so it is unknown whether the use of regulated pressures influences fatiguability or alters perceptual, cardiovascular and hemodynamic responses compared to a non-autoregulated cuff.
Therefore, the purpose of this study is to compare the perceptual, hemodynamic and cardiovascular responses using either an autoregulated pressure or a non-autoregulated pressure during a 20% 1RM leg extension non-failure and failure protocol in healthy, recreationally active male and female participants (without any history of BFR training) using the SmartTools Pro model (a device able to be autoregulated and non-autoregulated based on setting, providing an ability to directly compare autoregulation to non-autoregulation with a cuff of similar width).
Each participant will perform one familiarization session to determine 1RM, take baseline data for participant characteristics including limb occlusion pressure and relevant hemodynamic and cardiovascular measures, acclimate to the non-failure protocol without blood flow restriction and anchor perceptual baselines. Following familiarization session and at least 6 days between sessions, the dominant leg of each participant will be randomized to either the autoregulated or non-autoregulated pressure setting. Each participant will perform 4 sets of exercise applied in a continuous application setting using a commonly recommended protocol of 30-15-15-15 using a 2 second concentric/2 second eccentric tempo with 30-45 seconds of interset rest. The BFR cuff will either be set to autoregulation or non-autoregulated pressure setting. Following completion of the protocol, with the cuffs still inflated, all variables will be assessed again before deflating. Participants will return to the lab at least 6 days later at a similar time and perform the same protocol with the opposite condition.
To assess the differences in all relevant outcome measures during a failure routine, the same protocol will be completed 6 days later with each participant randomized to either the autoregulated or non-autoregulated group. Participants will complete a similar resistance training program using 4 sets to volitional fatigue instead of the non-failure protocol. The data provided within this study could greatly inform clinical practice if responses to non-autoregulated cuff applications in both non-failure and failure routines are heightened compared to autoregulated cuff applications. This study will also provide preliminary data for application in clinical populations such as those with knee osteoarthritis as well as applying a similar strategy to healthy populations in the upper extremity to determine if similar responses exist between limbs.
- Conditions
- Healthy
- Being tested
- Autoregulated Blood Flow Restriction Cuff (smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training, Non-autoregulated blood flow restriction cuff ((smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training)
- Keywords
- Blood Flow Restriction, Strength training, Cardiovascular safety, Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autoregulated Blood Flow Restriction Cuff (smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength trainingDevice
Also called Kaatsu, Partial vascular occlusion
This group will undergo 2 sessions consisting of a low load leg extension exercise combined with a pressurized tourniquet which autoregulates so when the quadriceps muscle contracts, the total amount of pressure doesn't increase, as the tourniquet will lower the pressure to keep the total amount of pressure constant.
Non-autoregulated blood flow restriction cuff ((smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training)Device
Also called Kaatsu, Partial vascular occlusion
This group will undergo 2 sessions consisting of a low load leg extension exercise combined with a pressurized tourniquet which does not autoregulate so when the quadriceps muscle contracts, the total amount of pressure will increase, as the tourniquet will not lower the pressure to keep the total amount of pressure constant.
| Study group | Role | What they receive |
|---|---|---|
| Autoregulated cuff | Experimental | two sessions in which an autoregulated cuff will be used to adapt the pressure in order to keep the total pressure given constant. First session will be within a 30-15-15-15 reps protocol, the second session will be performed until max fatigue. Receives: Device: Autoregulated Blood Flow Restriction Cuff (smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training |
| non-autoregulated cuff | Active comparator | two sessions in which an non-autoregulated cuff will be used. In these two sessions, the pressure will not be adapted. Consequently, during each muscle contraction the pressure will rise because the cuff is not autoregulated. First session will be within a 30-15-15-15 reps protocol, the second session will be performed until max fatigue. Receives: Device: Non-autoregulated blood flow restriction cuff ((smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate
Effect of leg extension exercise with blood flow restriction on the cardiovascular system
Measured: 5 weeks
Change in blood pressure
Effect of leg extension exercise with blood flow restriction on the hemodynamic system
Measured: 5 weeks
Change in rate of perceived exertion (RPE)
What is the perception of the patient when doing leg extensions with BFR
Measured: 5 weeks
Secondary outcomes (3)
Change in 1 repetition maximum
heighest weight a participant can lift by doing a leg extension
Measured: 5 weeks
Change in fatiguability
What is the amount of weight a participant can lift during a whole session.
Measured: 5 weeks
change in delayed onset muscle soreness
Does the participant feels stiff/sore 24 hours after the exercise
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start2 Oct 2021
- Primary completion23 Dec 2021
- Study completion3 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Erik Witvrouw, Prof. dr., Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145335
- Sponsor's protocol ID
- BC-11035
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptual, Hemodynamic and Cardiovascular Responses of Two Different BFR Training Protocols Using Either an Autoregulated Pressure or a Non-autoregulated Pressure
- ClinicalTrials.gov ID
- NCT05145335
- Acronym / sponsor ID
- BC-11035
- Conditions
- Healthy
- Keywords
- Blood Flow Restriction, Strength training, Cardiovascular safety, Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- 2 Oct 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 3 Apr 2022 (actual)
- First posted
- 6 Dec 2021 (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.
BFR training is growing in popularity and a variety of devices are on the market for clinical use. One way in which it is thought that BFR resistance training safety can be increased is by using a BFR cuff that regulates the applied pressure to the limb during each repetition. This is thought to reduce perceptual, hemodynamic and cardiovascular responses to non-autoregulated approaches, theoretically increasing long-term compliance and safety with BFR training.
Detailed description
BFR training is growing in popularity and a variety of devices are on the market for clinical use. One way in which it is thought that BFR resistance training safety can be increased is by using a BFR cuff that regulates the applied pressure to the limb during each repetition. This is thought to reduce perceptual, hemodynamic and cardiovascular responses to non-autoregulated approaches, theoretically increasing long-term compliance and safety with BFR training.
However, only one study has directly compared the effect of an autoregulated vs. non-autoregulated and their design did not standardize the cuff width between the autoregulated and the non-autoregulated cuff, potentially leading to differences in observed outcomes. That study concluded that autoregulated cuffs better manage the hemodynamic and perceptual responses to non-failure training protocols while providing a more accurate cuff-limb interface pressure, thus increasing safety profile. Moreover, BFR resistance training is commonly performed to failure so it is unknown whether the use of regulated pressures influences fatiguability or alters perceptual, cardiovascular and hemodynamic responses compared to a non-autoregulated cuff.
Therefore, the purpose of this study is to compare the perceptual, hemodynamic and cardiovascular responses using either an autoregulated pressure or a non-autoregulated pressure during a 20% 1RM leg extension non-failure and failure protocol in healthy, recreationally active male and female participants (without any history of BFR training) using the SmartTools Pro model (a device able to be autoregulated and non-autoregulated based on setting, providing an ability to directly compare autoregulation to non-autoregulation with a cuff of similar width).
Each participant will perform one familiarization session to determine 1RM, take baseline data for participant characteristics including limb occlusion pressure and relevant hemodynamic and cardiovascular measures, acclimate to the non-failure protocol without blood flow restriction and anchor perceptual baselines. Following familiarization session and at least 6 days between sessions, the dominant leg of each participant will be randomized to either the autoregulated or non-autoregulated pressure setting. Each participant will perform 4 sets of exercise applied in a continuous application setting using a commonly recommended protocol of 30-15-15-15 using a 2 second concentric/2 second eccentric tempo with 30-45 seconds of interset rest. The BFR cuff will either be set to autoregulation or non-autoregulated pressure setting. Following completion of the protocol, with the cuffs still inflated, all variables will be assessed again before deflating. Participants will return to the lab at least 6 days later at a similar time and perform the same protocol with the opposite condition.
To assess the differences in all relevant outcome measures during a failure routine, the same protocol will be completed 6 days later with each participant randomized to either the autoregulated or non-autoregulated group. Participants will complete a similar resistance training program using 4 sets to volitional fatigue instead of the non-failure protocol. The data provided within this study could greatly inform clinical practice if responses to non-autoregulated cuff applications in both non-failure and failure routines are heightened compared to autoregulated cuff applications. This study will also provide preliminary data for application in clinical populations such as those with knee osteoarthritis as well as applying a similar strategy to healthy populations in the upper extremity to determine if similar responses exist between limbs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autoregulated cuff | Experimental | Device: Autoregulated Blood Flow Restriction Cuff (smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength trainingtwo sessions in which an autoregulated cuff will be used to adapt the pressure in order to keep the total pressure given constant. First session will be within a 30-15-15-15 reps protocol, the second session will be performed until max fatigue. |
| non-autoregulated cuff | Active comparator | Device: Non-autoregulated blood flow restriction cuff ((smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training)two sessions in which an non-autoregulated cuff will be used. In these two sessions, the pressure will not be adapted. Consequently, during each muscle contraction the pressure will rise because the cuff is not autoregulated. First session will be within a 30-15-15-15 reps protocol, the second session will be performed until max fatigue. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy participants
- Be motivated to visit Ghent University Hospital 5 times for 30 minutes
Key exclusion criteria (8 listed)
- Suffering from a neuromuscular disease, affecting lower limbs
- Reduced functioning or pain in the dominant leg
- Taking pain medication
- Previous cardiovascular surgery affecting lower limbs
- Symptomatic cardiovascular or hemodynamic suffering
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 |
|---|---|---|
| Autoregulated Blood Flow Restriction Cuff (smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength trainingAlso: Kaatsu, Partial vascular occlusionThis group will undergo 2 sessions consisting of a low load leg extension exercise combined with a pressurized tourniquet which autoregulates so when the quadriceps muscle contracts, the total amount of pressure doesn't increase, as the tourniquet will lower the pressure to keep the total amount of pressure constant. | Device | Autoregulated cuff |
| Non-autoregulated blood flow restriction cuff ((smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training)Also: Kaatsu, Partial vascular occlusionThis group will undergo 2 sessions consisting of a low load leg extension exercise combined with a pressurized tourniquet which does not autoregulate so when the quadriceps muscle contracts, the total amount of pressure will increase, as the tourniquet will not lower the pressure to keep the total amount of pressure constant. | Device | non-autoregulated cuff |
Primary outcome
Change in heart rate
Time frame: 5 weeks
Effect of leg extension exercise with blood flow restriction on the cardiovascular system
Change in blood pressure
Time frame: 5 weeks
Effect of leg extension exercise with blood flow restriction on the hemodynamic system
Change in rate of perceived exertion (RPE)
Time frame: 5 weeks
What is the perception of the patient when doing leg extensions with BFR
3 secondary outcomes
Change in 1 repetition maximum
Time frame: 5 weeks
Change in fatiguability
Time frame: 5 weeks
change in delayed onset muscle soreness
Time frame: 5 weeks
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 22 Nov 2023.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Erik Witvrouw, Prof. dr. study chair
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autoregulated Blood Flow Restriction Cuff (smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training and Non-autoregulated blood flow restriction cuff ((smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training) in people with Healthy, run by University Ghent at 1 site in Belgium.
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 8 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 22 Nov 2023. 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 Belgium. 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?
Change in heart rate (time frame: 5 weeks). The study lists 3 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 22 Nov 2023.