Effects of Exercise Training with Blood Flow Restriction

NCT ID: NCT06507501

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-02-06

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Blood Flow Restriction Exercise Training (BFRT)

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.

Group Type: EXPERIMENTAL

Low Load Blood Flow Restriction Exercise Training (LL-BFRE)

Intervention Type: 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.

Conventional Exercise Training

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.

Group Type: EXPERIMENTAL

High Load Resistive Exercise Training (HL-RE)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Volunteering to participate in the study,
• Being between the ages of 18-30.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atlas University

OTHER

Sponsor Role: lead

Responsible Party

Onur Turan

Research Assisstant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Onur Turan, Bachelor's

Role: PRINCIPAL_INVESTIGATOR

Atlas University

Locations

Onur Turan

Istanbul, Kağıthane, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Onur1

Identifier Type: -

Identifier Source: org_study_id