Effects of Exercise Training with Blood Flow Restriction
1 other identifier
interventional
30
1 country
1
Brief 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 cognitive performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2024
CompletedFirst Submitted
Initial submission to the registry
June 27, 2024
CompletedFirst Posted
Study publicly available on registry
July 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2025
CompletedFebruary 10, 2025
February 1, 2025
10 months
June 27, 2024
February 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Muscle Strength
Knee extansor and flexor muscle strength will be measured by using Hoggan Scientific; MicroFET2 brand hand-held dynamometer.
Baseline to 6 weeks after exercise training
Dynamic Balance
Dynamic balance will be assessed by using Y-Balance Test Lower Extremity.
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.
Baseline to 6 weeks after exercise training
Secondary Outcomes (4)
Funtional Performance
Baseline to 6 weeks after exercise training
Funtional Performance
Baseline to 6 weeks after exercise training
Cognitive Performance
Baseline to 6 weeks after exercise training
Cognitive Performance
Baseline to 6 weeks after exercise training
Other Outcomes (2)
Sociodemographic Information
Baseline
Physical Assessment
Baseline
Study Arms (2)
Blood Flow Restriction Exercise Training (BFRT)
EXPERIMENTALExercises 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
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Volunteering to participate in the study,
- Being between the ages of 18-30.
You may not qualify if:
- 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,
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atlas Universitylead
Study Sites (1)
Onur Turan
Istanbul, Kağıthane, 34408, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Onur Turan, Bachelor's
Atlas University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assisstant
Study Record Dates
First Submitted
June 27, 2024
First Posted
July 18, 2024
Study Start
April 15, 2024
Primary Completion
February 6, 2025
Study Completion
February 6, 2025
Last Updated
February 10, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share