NCT06507501

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

June 27, 2024

Last Update Submit

February 6, 2025

Conditions

Keywords

Blood Flow Restriction Exercise TrainingMuscle StrengthBalanceFunctional PerformanceCognitive Performance

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)

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.

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.

Other: High Load Resistive Exercise Training (HL-RE)

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.

Blood Flow Restriction Exercise Training (BFRT)

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.

Conventional Exercise Training

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Onur Turan

Istanbul, Kağıthane, 34408, Turkey (Türkiye)

Location

Study Officials

  • Onur Turan, Bachelor's

    Atlas University

    PRINCIPAL INVESTIGATOR

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

Locations