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Completed

NCT Number: NCT06962514

Low Load With Blood Flow Restriction for Improving Strength, Balance, and Cognition in Older Adults

This study aims to examine the effects of low load resistance exercise with a blood flow restriction cuff on muscle strength, balance, physical performance, depression, and cognitive function in community-dwelling older adults.

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Key information

Conditions

Blood Flow Restriction Exercise Balance Behavior Behavioral Symptoms Cognition Depression Elderly (People Aged 65 or More) Muscle Strength Resistance Training

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahmyook University, Graduate School of Physical Therapy

Seoul, 01795, South Korea

About this study

This randomized controlled trial investigates the effects of low-load resistance exercise combined with blood flow restriction (BFR) in community-dwelling older adults. A total of 26 participants aged 65 and older will be randomly assigned to either a BFR exercise group or a control group that performs the same resistance exercises without BFR.

The intervention will be conducted twice a week for 8 weeks (16 sessions total). The BFR cuffs will be applied at 50% of the participant's arterial occlusion pressure. Both groups will undergo the same exercise protocol, supervised by trained personnel. Assessments will be performed at baseline and after the intervention.

Primary outcome measures include lower limb strength (5 Times Sit-to-Stand Test), balance ability (Timed Up and Go test), gait performance (10-meter walk test, GaitRite), muscle mass index (SMI) using BWA 2.0, muscle thickness (quadriceps via ultrasound), cognitive function (MoCA), depression level (GDS-K).

Both participants and outcome assessors are blinded to group allocation. This study has received IRB approval from Sahmyook University Institutional Review Board.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Community-dwelling individuals aged 65 years and older who have not had a fall in the past year.
  • No neurological or musculoskeletal condition that would interfere with exercise performance.
  • Clear consciousness and able to communicate effectively.
  • Capable of reading and writing.
  • Able to understand the research explanation and provide informed consent.

Exclusion criteria

  • Orthopedic, neurological, or vascular conditions that may affect vital signs such as dizziness, blood pressure instability, or fall risk during assessment.
  • Any history of musculoskeletal surgery within the past 6 months.
  • Physician-determined health status that contraindicates exercise participation.
  • Cognitive or literacy impairments that hinder understanding of study procedures.

Treatment and study plan

Blood flow restriction cuff

Other

Use of blood flow restriction cuff during resistance training. The cuff pressure is set at 50% of the participant's arterial occlusion pressure.

Exercise without BFR cuff

Other

Resistance exercise performed without blood flow restriction. Same protocol as BFR group but without cuff application.

Primary outcomes

  1. Quadriceps muscle thickness (via ultrasound)

    Time frame: From baseline to the end of the 8-week intervention.

    Muscle thickness of the rectus femoris and vastus intermedius will be assessed using B-mode ultrasound at rest. Measurements will be taken pre- and post-intervention.

  2. Skeletal Muscle Mass Index (SMI)

    Time frame: From baseline to the end of the 8-week intervention.

    SMI will be calculated using appendicular lean mass obtained from bioelectrical impedance analysis (BWA 2.0) and height squared (kg/m²). Handgrip strength will also be assessed as an indicator of muscle function.

Secondary outcomes

  1. Lower limb strength (5 Times Sit to Stand Test)

    Time frame: From baseline to the end of the 8-week intervention.

    Lower extremity strength will be assessed using the Five Times Sit to Stand Test, measuring the time required to stand from a chair and sit down five times.

  2. Depression level (GDS-K)

    Time frame: From baseline to the end of the 8-week intervention.

    Depressive symptoms will be assessed using the Korean version of the Geriatric Depression Scale (GDS-K), a standardized self-report screening tool for older adults. It consists of 30 items, each answered with "Yes" or "No." The total score ranges from 0 to 30, with higher scores indicating more severe depressive symptoms. Scores are interpreted as follows: 0-13 = normal, 14-18 = mild depression, 19-21 = moderate depression, and 22 or above = severe depression.

  3. Cognitive function (MoCA)

    Time frame: From baseline to the end of the 8-week intervention.

    Cognitive function will be evaluated using the Korean version of the Montreal Cognitive Assessment (MoCA-K), a validated screening tool for mild cognitive impairment in older adults. It assesses multiple cognitive domains, including attention, memory, language, visuospatial skills, executive functions, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. A score below 23 is generally considered indicative of cognitive impairment. One point may be added for individuals with 6 or fewer years of formal education.

  4. Gait performance (10-meter walk test and Gaitrite)

    Time frame: From baseline to the end of the 8-week intervention.

    Gait speed and spatiotemporal gait parameters will be measured using a 10-meter walk test and GaitRite system at comfortable walking speed.

  5. Balance ability (TUG)

    Time frame: From baseline to the end of the 8-week intervention.

    Dynamic balance will be assessed using the Timed Up and Go (TUG) test.

Sponsors and collaborators

Lead sponsor

Sahmyook University

Other

Registry information

Official study title

Effects of Low Load Resistance Exercise With a Blood Flow Restriction Cuff on Strength, Balance, Physical Performance, Depression and Cognition in Older Adults: a Randomized Controlled Double-blind Study

Acronym: BFRT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 8, 2025
Registry last updated
Jul 31, 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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