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

NCT ID: NCT06962514

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2025-07-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-group parallel randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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BFR group

Exercise with BFR cuff

Group Type EXPERIMENTAL

Blood flow restriction cuff

Intervention Type 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 group

Exercise without BFR cuff

Group Type EXPERIMENTAL

Exercise without BFR cuff

Intervention Type OTHER

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

Interventions

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Blood flow restriction cuff

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

Intervention Type OTHER

Exercise without BFR cuff

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahmyook University

OTHER

Sponsor Role lead

Responsible Party

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Hongje Jang

Physical Therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sahmyook University, Graduate School of Physical Therapy

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2024-07-005-009

Identifier Type: -

Identifier Source: org_study_id

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