Clinical trial NCT06962514: Pilates With Blood Flow Restriction for Improving Strength, Balance, and Cognition in Older Adults
Official title: Effects of Pilates Exercise With a Blood Flow Restriction Cuff on Strength, Balance, Physical Performance, Depression and Cognition in Older Adults: a Randomized Controlled Double-blind Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group parallel randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quadriceps muscle thickness (via ultrasound)
timeFrame: From baseline to the end of the 8-week intervention.
measure: Skeletal Muscle Mass Index (SMI)
timeFrame: From baseline to the end of the 8-week intervention.
Secondary outcomes:
measure: Lower limb strength (5 Times Sit to Stand Test)
timeFrame: From baseline to the end of the 8-week intervention.
measure: Fall efficacy (K-FES-I)
timeFrame: From baseline to the end of the 8-week intervention.
measure: Depression level (GDS-K)
timeFrame: From baseline to the end of the 8-week intervention.
measure: Cognitive function (MoCA)
timeFrame: From baseline to the end of the 8-week intervention.
measure: Gait performance (10-meter walk test and Gaitrite)
timeFrame: From baseline to the end of the 8-week intervention.
measure: Balance ability (TUG and Good Balance system)
timeFrame: From baseline to the end of the 8-week intervention.
measure: Calf circumference
timeFrame: From baseline to the end of the 8-week intervention.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sahmyook University, Graduate School of Physical Therapy
Study officials:
References: