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OpenTrials
Completed

NCT Number: NCT06507501

Effects of Exercise Training with Blood Flow Restriction

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onur Turan

Istanbul, Kağıthane, 34408, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Dynamic Balance

    Time frame: Baseline to 6 weeks after exercise training

    Dynamic balance will be assessed by using Y-Balance Test Lower Extremity.

  3. 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.

Secondary outcomes

  1. Funtional Performance

    Time frame: Baseline to 6 weeks after exercise training

    Functional performance will be assessed by using 6 Minute Walk Test.

  2. Funtional Performance

    Time frame: Baseline to 6 weeks after exercise training

    Functional performance will be assessed by using Single Leg Hop Test.

  3. Cognitive Performance

    Time frame: Baseline to 6 weeks after exercise training

    Cognitive performance will be assessed by using Trail Making Test.

  4. Cognitive Performance

    Time frame: Baseline to 6 weeks after exercise training

    Cognitive performance will be assessed by using Stroop Colour and Word Test.

Other outcomes

  1. Sociodemographic Information

    Time frame: Baseline

    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.

  2. Physical Assessment

    Time frame: Baseline

    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".

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

Effects of Exercise Training with Blood Flow Restriction on Lower Extremity Muscle Strength, Balance, Functional and Cognitive Performance in Healthy Individuals

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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