Effects of Exercise Training with Blood Flow Restriction

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Low Load Blood Flow Restriction Exercise Training (LL-BFRE); Other: High Load Resistive Exercise Training (HL-RE)

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kağıthane
    • Istanbul, Kağıthane, Turkey, 34408
      • Onur Turan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Funtional Performance	Functional performance will be assessed by using 6 Minute Walk Test.	Baseline to 6 weeks after exercise training
Funtional Performance	Functional performance will be assessed by using Single Leg Hop Test.	Baseline to 6 weeks after exercise training
Cognitive Performance	Cognitive performance will be assessed by using Trail Making Test.	Baseline to 6 weeks after exercise training
Cognitive Performance	Cognitive performance will be assessed by using Stroop Colour and Word Test.	Baseline to 6 weeks after exercise training

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic Information	Age (years), gender, education level, smoking & alcohol habits, whether they have a chronic disease, whether they use any medication, and exercise habits of the individuals participating in the study will be recorded.	Baseline
Physical Assessment	Height (cm), body weight (kg) and body mass index (BMI) (kg/m2) will be measured. Height will be measure via stadiometer, body weight will be measure via weighing device and BMI will be calculated using with the formula "weight/height (m)2".	Baseline

Collaborators and Investigators

• Sponsor: Atlas University
• Investigators: Principal Investigator: Onur Turan, Bachelor's, Atlas University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): February 6, 2025
• Study Completion (Actual): February 6, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Balance; Muscle Strength; Functional Performance; Cognitive Performance; Blood Flow Restriction Exercise Training
• Other Study ID Numbers: Onur1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No