HealthyNCT06507501
Effects of Exercise Training with Blood Flow Restriction
A study testing Low Load Blood Flow Restriction Exercise Training (LL-BFRE) and High Load Resistive Exercise Training (HL-RE) in people with Healthy, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to compare the effects of low load blood flow restriction exercise (LL-BFRE) training versus high load resistance exercise (HL-RE) training in healthy young individuals on the parameters of lower extremity muscle strength, dynamic and static postural balance, functional performance and… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Low Load Blood Flow Restriction Exercise Training (LL-BFRE) and High Load Resistive Exercise Training (HL-RE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 6 Feb 2025
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the study,
- Being between the ages of 18-30.
Who cannot join
- Presence of any painful condition or pathology involving the lower extremity and lumbar spine and the presence of a surgical history,
- Presence of serious malalignment and deformity affecting the lower extremity,
- Presence of neuromuscular and metabolic disease,
- Presence of any disease affecting lower extremity circulation,
- Having a history of deep vein thrombosis and the presence of peripheral vascular disease,
- Presence of endothelial dysfunction (ED) and any disease that may cause ED,
Show all 11Show fewer
- Presence of active infection, cancer and having received radiotherapy / chemotherapy,
- Continuous use of anticoagulant medication,
- Having had COVID-19 in the last 3 months or having long COVID syndrome,
- Presence of a cognitive or mental disorder that would disability to participate in the study,
- Disruption of exercise program 3 times in a row
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exercise Training with Blood Flow Restriction on Lower Extremity Muscle Strength, Balance, Functional and Cognitive Performance in Healthy Individuals
In this study, it was aimed to compare the effects of low load blood flow restriction exercise (LL-BFRE) training versus high load resistance exercise (HL-RE) training in healthy young individuals on the parameters of lower extremity muscle strength, dynamic and static postural balance, functional performance and cognitive performance.
Read the detailed description
In this randomized controlled study, there will be two study group. Study group 1 will recieve low load blood flow restriction exercise training and Study group 2 will recieve high load resistance exercise training for 6 weeks, 2 exercise sessions weekly.
At baseline assessment, individuals who met the inclusion criteria, informed by the researcher and accept the participate in the study, researcher will record the participants' sociodemographic and physical informations and then, asess the lower extremity muscle strength with Hand-held digital dynamometer, dynamic postural balance with Y-Balance Test-Lower Quarter, static postural balance with Single Leg Stance Test (Eyes open/closed condition), functional performance with 6-Minute Walking Test and cognitive performance with Stroop Word and Colour Test and Trail Making Test.
At the end of the 6 week exercise training all participants will undergo the same assessments.
- Conditions
- Healthy
- Being tested
- Low Load Blood Flow Restriction Exercise Training (LL-BFRE), High Load Resistive Exercise Training (HL-RE)
- Keywords
- Blood Flow Restriction Exercise Training, Muscle Strength, Balance, Functional Performance, Cognitive Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Load Blood Flow Restriction Exercise Training (LL-BFRE)Other
Blood Flow Restriction exercise training, also known as occlusion training or KAATSU training, is a contemporary exercise training method based on partially restricting arterial and venous blood flow for short periods.
High Load Resistive Exercise Training (HL-RE)Other
HL-RE is a conventional, well known exercise method to enhance muscle strength and improve physical performance. It's performed by using resistance bands or weights applying on the extremity.
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction Exercise Training (BFRT) | Experimental | Exercises will be performed under the supervision of a researcher physiotherapist, at low intensity and progressively, under blood flow restriction for 6 weeks, 2 days a week, for a total of 12 exercise sessions. The 1 MT method will be used to determine the amount of resistance in strengthening exercises.
Blood flow restriction will be made by wearing a pneumatic tourniquet from the proximal thigh, within a safe pressure range specific to each individual.
Blood flow restriction United States Food and Drug Administration Using the (FDA) approved H+Cuff device, it will be applied for 20 minutes, with a 1-minute break between exercises. The cuff pressure will be maintained during the rest period, and after the application, individuals will rest for 15 minutes to ensure reperfusion and other exercises will continue. Receives: Other: Low Load Blood Flow Restriction Exercise Training (LL-BFRE) |
| Conventional Exercise Training | Experimental | Participants who will be included in the conventional exercise group will apply the same exercise program as the participants in the blood flow-restricted exercise group, without blood flow restriction, for 6 weeks, 2 days a week, in a total of 12 sessions, at medium-high intensity. Receives: Other: High Load Resistive Exercise Training (HL-RE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Knee extansor and flexor muscle strength will be measured by using Hoggan Scientific; MicroFET2 brand hand-held dynamometer.
Measured: Baseline to 6 weeks after exercise training
Dynamic Balance
Dynamic balance will be assessed by using Y-Balance Test Lower Extremity.
Measured: Baseline to 6 weeks after exercise training
Static Balance
Static balance will be assessed by using Single Leg Stance Test with eyes open and closed.
Measured: Baseline to 6 weeks after exercise training
Secondary outcomes (4)
Funtional Performance
Functional performance will be assessed by using 6 Minute Walk Test.
Measured: Baseline to 6 weeks after exercise training
Funtional Performance
Functional performance will be assessed by using Single Leg Hop Test.
Measured: Baseline to 6 weeks after exercise training
Cognitive Performance
Cognitive performance will be assessed by using Trail Making Test.
Measured: Baseline to 6 weeks after exercise training
Cognitive Performance
Cognitive performance will be assessed by using Stroop Colour and Word Test.
Measured: Baseline to 6 weeks after exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start15 Apr 2024
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Turan, Atlas University
- Investigators
- Onur Turan, Bachelor's, Principal investigator, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507501
- Sponsor's protocol ID
- Onur1
- Status last verified
- Feb 2025
- First submitted
- 27 Jun 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training with Blood Flow Restriction on Lower Extremity Muscle Strength, Balance, Functional and Cognitive Performance in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06507501
- Acronym / sponsor ID
- Onur1
- Conditions
- Healthy
- Keywords
- Blood Flow Restriction Exercise Training, Muscle Strength, Balance, Functional Performance, Cognitive Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 18 Jul 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.
In this study, it was aimed to compare the effects of low load blood flow restriction exercise (LL-BFRE) training versus high load resistance exercise (HL-RE) training in healthy young individuals on the parameters of lower extremity muscle strength, dynamic and static postural balance, functional performance and cognitive performance.
Detailed description
In this randomized controlled study, there will be two study group. Study group 1 will recieve low load blood flow restriction exercise training and Study group 2 will recieve high load resistance exercise training for 6 weeks, 2 exercise sessions weekly.
At baseline assessment, individuals who met the inclusion criteria, informed by the researcher and accept the participate in the study, researcher will record the participants' sociodemographic and physical informations and then, asess the lower extremity muscle strength with Hand-held digital dynamometer, dynamic postural balance with Y-Balance Test-Lower Quarter, static postural balance with Single Leg Stance Test (Eyes open/closed condition), functional performance with 6-Minute Walking Test and cognitive performance with Stroop Word and Colour Test and Trail Making Test.
At the end of the 6 week exercise training all participants will undergo the same assessments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction Exercise Training (BFRT) | Experimental | Other: Low Load Blood Flow Restriction Exercise Training (LL-BFRE)Exercises will be performed under the supervision of a researcher physiotherapist, at low intensity and progressively, under blood flow restriction for 6 weeks, 2 days a week, for a total of 12 exercise sessions. The 1 MT method will be used to determine the amount of resistance in strengthening exercises. Blood flow restriction will be made by wearing a pneumatic tourniquet from the proximal thigh, within a safe pressure range specific to each individual. Blood flow restriction United States Food and Drug Administration Using the (FDA) approved H+Cuff device, it will be applied for 20 minutes, with a 1-minute break between exercises. The cuff pressure will be maintained during the rest period, and after the application, individuals will rest for 15 minutes to ensure reperfusion and other exercises will continue. |
| Conventional Exercise Training | Experimental | Other: High Load Resistive Exercise Training (HL-RE)Participants who will be included in the conventional exercise group will apply the same exercise program as the participants in the blood flow-restricted exercise group, without blood flow restriction, for 6 weeks, 2 days a week, in a total of 12 sessions, at medium-high intensity. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Volunteering to participate in the study,
- Being between the ages of 18-30.
Key exclusion criteria (11 listed)
- Presence of any painful condition or pathology involving the lower extremity and lumbar spine and the presence of a surgical history,
- Presence of serious malalignment and deformity affecting the lower extremity,
- Presence of neuromuscular and metabolic disease,
- Presence of any disease affecting lower extremity circulation,
- Having a history of deep vein thrombosis and the presence of peripheral vascular disease,
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 |
|---|---|---|
| Low Load Blood Flow Restriction Exercise Training (LL-BFRE)Blood Flow Restriction exercise training, also known as occlusion training or KAATSU training, is a contemporary exercise training method based on partially restricting arterial and venous blood flow for short periods. | Other | Blood Flow Restriction Exercise Training (BFRT) |
| High Load Resistive Exercise Training (HL-RE)HL-RE is a conventional, well known exercise method to enhance muscle strength and improve physical performance. It's performed by using resistance bands or weights applying on the extremity. | Other | Conventional Exercise Training |
Primary outcome
Muscle Strength
Time frame: Baseline to 6 weeks after exercise training
Knee extansor and flexor muscle strength will be measured by using Hoggan Scientific; MicroFET2 brand hand-held dynamometer.
Dynamic Balance
Time frame: Baseline to 6 weeks after exercise training
Dynamic balance will be assessed by using Y-Balance Test Lower Extremity.
Static Balance
Time frame: Baseline to 6 weeks after exercise training
Static balance will be assessed by using Single Leg Stance Test with eyes open and closed.
4 secondary outcomes
Funtional Performance
Time frame: Baseline to 6 weeks after exercise training
Funtional Performance
Time frame: Baseline to 6 weeks after exercise training
Cognitive Performance
Time frame: Baseline to 6 weeks after exercise training
Cognitive Performance
Time frame: Baseline to 6 weeks after exercise training
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 10 Feb 2025.
- 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.
Onur Turan, Bachelor's principal investigator
Atlas 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 Low Load Blood Flow Restriction Exercise Training (LL-BFRE) and High Load Resistive Exercise Training (HL-RE) in people with Healthy, run by Atlas University at 1 site in Turkey (Türkiye).
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 11 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 10 Feb 2025. 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 Turkey (Türkiye). 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?
Muscle Strength (time frame: Baseline to 6 weeks after exercise training). 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 10 Feb 2025.