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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06962514
Acronym
BFRT
Enrollment
26
Registered
2025-05-08
Start date
2025-05-12
Completion date
2025-07-14
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Blood flow restriction training, Older adults, Muscle mass, Functional Mobility, Cognition

Brief summary

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.

Detailed description

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.

Interventions

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

OTHERExercise without BFR cuff

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

Sponsors

Sahmyook University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants and outcome assessors were blinded to group assignment. Both groups followed the same exercise protocol, and the use of BFR cuffs was not disclosed.

Intervention model description

Two-group parallel randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Community-dwelling individuals aged 65 years and older who have not had a fall in the past year. 2. No neurological or musculoskeletal condition that would interfere with exercise performance. 3. Clear consciousness and able to communicate effectively. 4. Capable of reading and writing. 5. Able to understand the research explanation and provide informed consent.

Exclusion criteria

1. Orthopedic, neurological, or vascular conditions that may affect vital signs such as dizziness, blood pressure instability, or fall risk during assessment. 2. Any history of musculoskeletal surgery within the past 6 months. 3. Physician-determined health status that contraindicates exercise participation. 4. Cognitive or literacy impairments that hinder understanding of study procedures.

Design outcomes

Primary

MeasureTime frameDescription
Quadriceps muscle thickness (via ultrasound)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.
Skeletal Muscle Mass Index (SMI)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

MeasureTime frameDescription
Cognitive function (MoCA)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.
Lower limb strength (5 Times Sit to Stand Test)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.
Balance ability (TUG)From baseline to the end of the 8-week intervention.Dynamic balance will be assessed using the Timed Up and Go (TUG) test.
Gait performance (10-meter walk test and Gaitrite)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.
Depression level (GDS-K)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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026