An interventional study of Blood flow restriction cuff and Exercise without BFR cuff in Blood Flow Restriction Exercise, Resistance Training and Elderly (People Aged 65 or More), sponsored by Sahmyook University. Completed at 1 site in South Korea. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Sahmyook University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 26 is below the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
Exercise with BFR cuff
Other: Blood flow restriction cuff
Exercise without BFR cuff
Other: Exercise without BFR cuff
Use of blood flow restriction cuff during resistance training. The cuff pressure is set at 50% of the participant's arterial occlusion pressure.
Resistance exercise performed without blood flow restriction. Same protocol as BFR group but without cuff application.
Quadriceps muscle thickness (via ultrasound)
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.
Time frame: From baseline to the end of the 8-week intervention.
Skeletal Muscle Mass Index (SMI)
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.
Time frame: From baseline to the end of the 8-week intervention.
Lower limb strength (5 Times Sit to Stand Test)
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.
Time frame: From baseline to the end of the 8-week intervention.
Depression level (GDS-K)
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.
Time frame: From baseline to the end of the 8-week intervention.
Cognitive function (MoCA)
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.
Time frame: From baseline to the end of the 8-week intervention.
Gait performance (10-meter walk test and Gaitrite)
Gait speed and spatiotemporal gait parameters will be measured using a 10-meter walk test and GaitRite system at comfortable walking speed.
Time frame: From baseline to the end of the 8-week intervention.
Balance ability (TUG)
Dynamic balance will be assessed using the Timed Up and Go (TUG) test.
Time frame: From baseline to the end of the 8-week intervention.
Plan to share: Undecided — The decision to share individual participant data (IPD) has not been finalized. The data may be considered for sharing after de-identification and upon request, depending on future publication requirements and institutional policy.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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