Effects of Pilates Exercise With a Blood Flow Restriction Cuff on Strength, Balance, Physical Performance, Depression and Cognition in Older Adults (BFRT)

Sahmyook University

Status: Not yet enrolling

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

Treatments: Other: Blood flow restriction cuff; Other: Exercise without BFR cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT06962514

2024-07-005-009

Details and patient eligibility

About

This study aims to examine the effects of Pilates exercise with a blood flow restriction cuff on muscle strength, balance, physical performance, depression, and cognitive function in community-dwelling older adults.

Full description

This randomized controlled trial investigates the effects of Pilates 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 Pilates group or a control group that performs the same Pilates 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 Pilates 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, Good Balance System), gait performance (10-meter walk test, GaitRite), muscle mass index (SMI) using BWA 2.0 and handgrip strength, muscle thickness (quadriceps via ultrasound and calf circumference), cognitive function (MoCA), depression level (GDS-K), and fall efficacy (K-FES-I).

Both participants and outcome assessors are blinded to group allocation. This study has received IRB approval from Sahmyook University Institutional Review Board.

Enrollment: 26 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

BFR group

Experimental group

Description:

Exercise with BFR cuff

Treatment:

Other: Blood flow restriction cuff

Exercise group

Experimental group

Description:

Exercise without BFR cuff

Treatment:

Other: Exercise without BFR cuff