Effects of Low Load Resistance Exercise With a Blood Flow Restriction Cuff on Strength, Balance, Physical Performance, Depression and Cognition in Older Adults: a Randomized Controlled Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Quadriceps muscle thickness (via ultrasound)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
BFR group
Exercise with BFR cuff
干预措施: Blood flow restriction cuff (Other)
Exercise group
Exercise without BFR cuff
干预措施: Exercise without BFR cuff (Other)
结局指标
主要结局
Quadriceps muscle thickness (via ultrasound)
时间窗: From baseline to the end of the 8-week intervention.
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.
Skeletal Muscle Mass Index (SMI)
时间窗: From baseline to the end of the 8-week intervention.
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.
次要结局
- Gait performance (10-meter walk test and Gaitrite)(From baseline to the end of the 8-week intervention.)
- 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.)
- 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.)
研究者
Hongje Jang
Physical Therapist
Sahmyook University