Effects of Resistance-based Exercise Snacks With Varying Fragmentation Patterns on Lower Limb Function and Executive Cognition in Pre-frail Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Lower Limb Muscle Strength
研究概览
简要总结
This four-arm randomized pilot trial (N=48-60) compares four fragmentation patterns of a three-exercise resistance snack (sit-to-stand, squat, heel raise; 15 repetitions/exercise/day) in pre-frail older adults (Fried score 1-2, ≥70 years). Groups differ by repetitions/bout×bouts/day: G1=1×15, G2=3×5, G3=5×3, G4=15×1. Outcomes (lower limb strength, balance, executive function) are assessed at baseline, week 4, and week 8. The study will determine the optimal fragmentation pattern and provide effect sizes for a future definitive trial.
详细描述
This is a four-arm, parallel-group, randomized controlled pilot trial. Forty-eight to sixty community-dwelling pre-frail older adults (Fried frailty phenotype score 1-2, aged ≥70 years) will be randomly assigned to one of four groups (1:1:1:1 ratio). All groups perform a fixed total daily volume of 15 repetitions per exercise (sit-to-stand, squat, and heel raise), resulting in 45 total repetitions per day. The only difference between groups is the fragmentation pattern (i.e., repetitions per bout × bouts per day):
G1 (highly fragmented): 1 repetition of each exercise per bout, 15 bouts/day (~30 seconds per bout)
G2 (moderately fragmented): 3 repetitions of each exercise per bout, 5 bouts/day (~90 seconds per bout)
G3 (lowly fragmented): 5 repetitions of each exercise per bout, 3 bouts/day (~2.5 minutes per bout)
G4 (consecutive control): 15 repetitions of each exercise per bout, 1 bout/day (~7.5 minutes per bout)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is a four-arm, parallel-group, randomized controlled pilot trial. Sixty community-dwelling pre-frail older adults (Fried frailty phenotype score 1-2, aged ≥70 years) will be randomly assigned to one of four groups (1:1:1:1 ratio). All groups perform a fixed total daily volume of 15 repetitions per exercise (sit-to-stand, squat, and heel raise), resulting in 45 total repetitions per day.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1. Age 65 years or older
- •Community-dwelling (living independently, not in a nursing home or long-term care facility)
- •Pre-frail status confirmed by Fried Frailty Phenotype score of 1-2
- •Mini-Mental State Examination (MMSE) score ≥24
- •Able to walk independently with or without a cane
- •No regular lower limb strength training (less than 2 times per week) in the past 3 months
- •Willing to adhere to the 8-week exercise intervention and complete all assessments
- •Provide written informed consent before any study-related procedures
排除标准
- •1. Lower limb fracture or joint replacement surgery within the past 6 months
- •Unstable angina or uncontrolled hypertension (resting systolic blood pressure ≥160 mmHg)
- •Severe osteoporosis (T-score <-2.5 with history of fragility fracture)
- •Neurological disorders affecting motor function (e.g., Parkinson's disease, post-stroke hemiplegia)
- •Severe cognitive impairment (MMSE score <24)
- •Unstable cardiac or pulmonary disease (e.g., recent myocardial infarction, severe COPD exacerbation)
- •Severe visual or hearing impairment that limits ability to follow instructions or perform exercises safely
- •Participation in another interventional clinical trial within the past 30 days
- •Any other medical or psychological condition that, in the opinion of the principal investigator, would compromise participant safety or study adherence
研究组 & 干预措施
Arm 1：Highly Fragmented Exercise Snack Group
Arm 1：Participants perform 1 repetition of each exercise (sit-to-stand, squat, and heel raise) per bout, 15 bouts per day, for 8 weeks. Each bout takes approximately 30 seconds.
干预措施: Highly Fragmented Exercise Snack (Behavioral)
Arm 2：Moderately Fragmented Exercise Snack Group
Arm 2：Participants perform 3 repetitions of each exercise (sit-to-stand, squat, and heel raise) per bout, 5 bouts per day, for 8 weeks. Each bout takes approximately 90 seconds.
干预措施: Moderately Fragmented Exercise Snack (Behavioral)
Arm 3：Lowly Fragmented Exercise Snack Group
Arm 3：Participants perform 5 repetitions of each exercise (sit-to-stand, squat, and heel raise) per bout, 3 bouts per day, for 8 weeks. Each bout takes approximately 2.5 minutes.
干预措施: Lowly Fragmented Exercise Snack (Behavioral)
Arm 4：Consecutive Control Group
Arm 4：Participants perform 15 repetitions of each exercise (sit-to-stand, squat, and heel raise) per bout, 1 bout per day, for 8 weeks. Each bout takes approximately 7.5 minutes.
干预措施: Consecutive Exercise (Active Control) (Behavioral)
结局指标
主要结局
Lower Limb Muscle Strength
时间窗: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
Measured by the 30-Second Chair Stand Test (30-CST). The number of times a participant can stand up from a sitting position and sit back down within 30 seconds. A higher score indicates better lower limb strength.
Dynamic Balance and Mobility
时间窗: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
Measured by the Timed Up and Go (TUG) test. The time (in seconds) taken to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. A shorter time indicates better dynamic balance and mobility.
次要结局
未报告次要终点
研究者
Yongzhao Fan
Associate Professor
Capital University of Physical Education and Sports, China