The Effects of Blood Flow Restriction Training Parameters on Lower Limb Muscle Function in Elderly Adults With Dynapenia: Mechanism and Intervention Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Baseline Data
研究概览
简要总结
The objective of the first year is to collect limb occlusion pressure (LOP) measurements in older adults with varying levels of muscle health, which will serve as foundational data for subsequent investigations on blood flow restriction (BFR) combined with resistance training in individuals with dynapenia. This phase aims to examine LOP values and their potential influencing factors, including demographic and physiological characteristics such as age, height, body weight, blood pressure, waist circumference, body fat percentage, medical history of chronic diseases, and habitual physical activity. Muscle-related assessments will include skeletal muscle mass, thigh and calf circumference, handgrip strength, and lower limb muscle strength. Functional performance will be evaluated using the five-times sit-to-stand test and the SARC-F questionnaire for sarcopenia risk screening. LOP of the lower limbs will be measured using a BFR cuff system combined with a laboratory-developed blood flow detection device. The study will further investigate whether LOP values are associated with the aforementioned factors.
The objective of the second year is to utilize high-density surface electromyography (dEMG) to analyze the electrophysiological characteristics of muscle contraction in individuals with sarcopenia under varying BFR pressures and resistance intensities. This includes examining motor unit recruitment patterns and recruitment thresholds, with the goal of identifying effective and appropriate BFR exercise parameters for this population.
The objective of the third year is to investigate the effects of lower limb BFR combined with resistance training on functional performance in individuals with dynapenia. Building upon the findings from the first year, this phase will implement BFR resistance training interventions and evaluate both short-term and long-term effects. Through an experimental design, the study will assess changes in body composition, muscle strength, and functional performance following a four-month intervention, along with a three-month follow-up period, to determine whether participants can improve to a healthy status and maintain these improvements over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 55 years and older.
- •No regular physical activity within the past three months, defined as exercising no more than twice per week.
- •No cognitive impairment and able to follow exercise and assessment instructions.
排除标准
- •Have contraindications to exercise, such as severe musculoskeletal problems, osteoporosis, deep vein thrombosis, or coagulation disorders.
- •Have comorbid conditions that are severe or end-stage, such as stroke diagnosed by a neurologist, diabetes with severe complications (e.g., retinopathy), or cardiovascular disease including heart failure, coronary ischemia, or arrhythmia.
- •Have high-risk factors for exercise, such as uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg), angina or chest tightness during exercise, or deep vein thrombosis.
- •Have a history of hematologic disorders or are currently taking blood-related medications, such as hormones or anticoagulants.
- •Are expected to move out of the local community within three months.
研究组 & 干预措施
Blood Flow Restriction Group (BFR)
Receive low intensity lower limb resistance training with the use of Blood Flow Restriction
干预措施: Blood Flow Restriction (Device)
Conventional Resistance Training Group (CRT)
Receive traditional high intensity lower-limb resistance training
干预措施: Conventional Resistance Training (Other)
结局指标
主要结局
Baseline Data
时间窗: week0(pre-intervention), week16(post-intervention)
Collect data on participants' demographics including gender, age, education level, living situation, lifestyle habits (such as alcohol consumption and smoking), and health status with chronic disease history. Daily activity patterns are assessed using the International Physical Activity Questionnaire - Short Self-Administered Taiwanese Chinese Version (IPAQ), which surveys participants' activities of different intensities over the past seven days.
Muscle Strength
时间窗: week0(pre-intervention), week16(post-intervention)
Hand Grip Strength measured via a Dynamometer, recorded in kg Knee Extensor Strength measured via a hand-held Dynamometer
Muscle Function: The Short Physical Performance Battery (SPPB)
时间窗: week0(pre-intervention), week16(post-intervention)
The Short Physical Performance Battery (SPPB) evaluates lower extremity function through three tasks: standing balance (side-by-side, semi-tandem, tandem), 4-meter gait speed, and a 5-repetition chair stand test. Each task is scored from 0 (inability to complete) to 4 (best performance). The three component scores are summed for a total score ranging from 0 to 12, with higher scores indicating better physical performance. Unit of Measure: scores on a scale (points)
Height
时间窗: week0(pre-intervention), week16(post-intervention)
Standard Measurements: Height, recorded in centimeters.
Weight
时间窗: week0(pre-intervention), week16(post-intervention)
Standard Measurements: Weight, recorded in kilograms(kg)
BMI
时间窗: week0(pre-intervention), week16(post-intervention)
weight and height will be combined to report BMI in kg/m\^2
Blood Pressure
时间窗: week0(pre-intervention), week16(post-intervention)
Measured via a Blood Pressure Monitor, Systolic Blood Pressure and Diastolic Blood Pressure will be recorded in mmHg
Circumferences
时间窗: week0(pre-intervention), week16(post-intervention)
Waist line, Thigh Circumference, Calf Circumference will be using standard tape measure and recorded in centimeter(cm)
SARC-F Questionnaire
时间窗: week0(pre-intervention)
The questionnaire consists of five items, each scored 0, 1, or 2, with higher scores indicating greater difficulty for the participant. The total score ranges from 0 to 10. The items assess difficulty in Strength, Assistance in walking, Rising from a chair, Climbing, and Fall. A SARC-F score greater than 4 indicates a population at risk for sarcopenia.
Electromyography(EMG)
时间窗: week0(pre-intervention), week16(post-intervention)
Electromyography characteristics of Vastus Lateralis and Vastus Medialis
Limb Occlusion Pressure(LOP)
时间窗: week0(pre-intervention)
Measured in a seated position with the knee fully extended, using a laboratory-developed blood flow occlusion detection system. During the measurement, a manually inflated pressure cuff was placed at the proximal thigh near the hip joint, while a photoplethysmography (PPG) sensor and a temperature sensor were positioned over the dorsalis pedis artery on the anterior aspect of the ankle to detect distal PPG and temperature signals.
Skeletal muscle mass
时间窗: week0(pre-intervention), week16(post-intervention)
Measured by Bioelectrical Impedance Analysis(BIA), recorded in kilograms(kg)
Body fat percentage
时间窗: week0(pre-intervention), week16(post-intervention)
Measured by Bioelectrical Impedance Analysis(BIA), recorded in percentage(%)
Estimated appendicular skeletal muscle mass
时间窗: week0(pre-intervention), week16(post-intervention)
Measured by Bioelectrical Impedance Analysis(BIA), recorded in kilograms(kg)
次要结局
未报告次要终点
研究者
Chih-Yu Lin
Principal Investigator
Kaohsiung Medical University