Blood Flow Restriction ExerciseBFRTNCT06962514
Low Load With Blood Flow Restriction for Improving Strength, Balance, and Cognition in Older Adults
A study testing Blood flow restriction cuff and Exercise without BFR cuff in people with Blood Flow Restriction Exercise and Resistance Training, run by Sahmyook University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Blood Flow Restriction Exercise, Resistance Training, Elderly (People Aged 65 or More)
- What is being tested?
- Blood flow restriction cuff and Exercise without BFR cuff
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2025to 14 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Sahmyook University, Graduate School of Physical Therapy
Seoul, 01795
About this study
Official 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 Study
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.
Read the 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).
Outcome assessors are blinded to group allocation. This study has received IRB approval from Sahmyook University Institutional Review Board.
- Conditions
- Blood Flow Restriction Exercise, Resistance Training, Elderly (People Aged 65 or More), Muscle Strength, Balance, Cognition
- Being tested
- Blood flow restriction cuff, Exercise without BFR cuff
- Keywords
- Blood flow restriction training, Older adults, Muscle mass, Functional Mobility, Cognition
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction cuffOther
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 cuffOther
Resistance exercise performed without blood flow restriction. Same protocol as BFR group but without cuff application.
| Study group | Role | What they receive |
|---|---|---|
| BFR group | Experimental | Exercise with BFR cuff Receives: Other: Blood flow restriction cuff |
| Exercise group | Experimental | Exercise without BFR cuff Receives: Other: Exercise without BFR cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to the end of the 8-week intervention.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to the end of the 8-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start12 May 2025
- Primary completion10 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Flow Restriction ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group parallel randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongje Jang, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962514
- Sponsor's protocol ID
- 2024-07-005-009
- Acronym
- BFRT
- Status last verified
- Jul 2025
- First submitted
- 30 Apr 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 Study
- ClinicalTrials.gov ID
- NCT06962514
- Acronym / sponsor ID
- BFRT / 2024-07-005-009
- Conditions
- Blood Flow Restriction Exercise, Resistance Training, Elderly (People Aged 65 or More), Muscle Strength, Balance, Cognition
- Keywords
- Blood flow restriction training, Older adults, Muscle mass, Functional Mobility, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Outcome assessors are blinded to group allocation. This study has received IRB approval from Sahmyook University Institutional Review Board.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-group parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| BFR group | Experimental | Other: Blood flow restriction cuffExercise with BFR cuff |
| Exercise group | Experimental | Other: Exercise without BFR cuffExercise without BFR cuff |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction cuffUse of blood flow restriction cuff during resistance training. The cuff pressure is set at 50% of the participant's arterial occlusion pressure. | Other | BFR group |
| Exercise without BFR cuffResistance exercise performed without blood flow restriction. Same protocol as BFR group but without cuff application. | Other | Exercise group |
Primary outcome
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.
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.
5 secondary outcomes
Lower limb strength (5 Times Sit to Stand Test)
Time frame: From baseline to the end of the 8-week intervention.
Depression level (GDS-K)
Time frame: From baseline to the end of the 8-week intervention.
Cognitive function (MoCA)
Time frame: From baseline to the end of the 8-week intervention.
Gait performance (10-meter walk test and Gaitrite)
Time frame: From baseline to the end of the 8-week intervention.
Balance ability (TUG)
Time frame: From baseline to the end of the 8-week intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction cuff and Exercise without BFR cuff in people with Blood Flow Restriction Exercise and Resistance Training, run by Sahmyook University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps muscle thickness (via ultrasound) (time frame: From baseline to the end of the 8-week intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.