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

NCT06962514 | Completed

• 1 other identifier: 2024-07-005-009
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (5)

• Lower limb strength (5 Times Sit to Stand Test)

  From baseline to the end of the 8-week intervention.

• Depression level (GDS-K)

  From baseline to the end of the 8-week intervention.

• Cognitive function (MoCA)

  From baseline to the end of the 8-week intervention.

• Gait performance (10-meter walk test and Gaitrite)

  From baseline to the end of the 8-week intervention.

• Balance ability (TUG)

  From baseline to the end of the 8-week intervention.

Study Arms (2)

BFR group

EXPERIMENTAL

Exercise with BFR cuff

Other: Blood flow restriction cuff

Exercise group

EXPERIMENTAL

Exercise without BFR cuff

Other: Exercise without BFR cuff

Interventions

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.

BFR group

Exercise without BFR cuff OTHER

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

Exercise group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahmyook University: lead

Study Sites (1)

Sahmyook University, Graduate School of Physical Therapy

Seoul, 01795, South Korea

Location

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: Two-group parallel randomized controlled trial

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: May 12, 2025
• Primary Completion: July 10, 2025
• Study Completion: July 14, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

KR (1)