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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BFR group | Experimental | Exercise with BFR cuff |
|
| Exercise group | Experimental | Exercise without BFR cuff |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From baseline to the end of the 8-week intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to the end of the 8-week intervention. |
| Depression level (GDS-K) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahmyook University, Graduate School of Physical Therapy | Seoul | 01795 | South Korea |
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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Two-group parallel randomized controlled trial
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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.
| Exercise without BFR cuff | Other | Resistance exercise performed without blood flow restriction. Same protocol as BFR group but without cuff application. |
|
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. |
| 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. | 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. | 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. | From baseline to the end of the 8-week intervention. |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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