增强身体储备以促进身体虚弱老年人的恢复力 (MRI exercise)
增强身体储备以促进身体衰弱老年人的认知与身体韧性:一项为期3个月的随机对照试验
The goal of this clinical trial is to assess the efficacy of combined aerobic and resistance training in enhancing physical reserve in older adults with physical frailty. Investigator contend that enhanced physical reserve will enable preservation of cognitive and physical function. The main questions aims to answer are: (1) Compared with usual care (i.e., CON), will 3-month aerobic and resistance training (ATRT) improve physical reserve in older adults with physical frailty? (2) Compared with CON, will ATRT lead to changes in the neural network organization? (3) Will improved physical reserve lead to better maintenance of cognitive and physical functioning in spite of presence of white matter hyperintensities (WMH)?
研究概览
详细说明
Objectives: (1) To compared with usual care (i.e., CON), will 3-month aerobic and resistance training (ATRT) improve physical reserve in older adults with physical frailty? (2) Compared with CON, will ATRT lead to changes in the neural network organization? (3) Will improved physical reserve lead to better maintenance of cognitive and physical functioning in spite of presence of white matter hyperintensities (WMH)? (4) What is the association between exercise, neural network, and physical reserve? Hypotheses: Investigator hypothesize that (1) compared to participants randomly assigned to the CON, participants randomly assigned to the 3-month ATRT will show significantly enhanced physical reserve. (2) compared with participants randomly assigned to CON, participants randomly assigned to ATRT will show reduction in Dorsal Attention Network connectivity. (3) Enhanced physical reserve will moderate the negative association between WMH and Trail Making Test performance, as well as WMH and Short Physical Performance Battery performance. (4) combined aerobic and resistance training will enhance physical reserve via a mediated relationship with reduced Dorsal Attention Network connectivity.
Design and subjects: A randomized controlled trial involving 224 community-dwelling older adults with physical frailty Study instruments: Magnetic resonance imaging Interventions: The designed exercise training will be progressive and moderate in intensity. Participants randomized to the ATRT group will undergo a 3-month (i.e., 13-weeks) four-sessions-per-week, 60-minute-per-session exercise with a 10-minute warm-up, 40-minute of moderate intensity exercise training, and 10-minute cool-down. There will be a total of 52 exercise sessions with a 1:3 research staffs (i.e., instructor and assistants) to study participants ratio. To promote participant safety, investigator will limit each session to 12 study participants. To ensure fidelity of the intervention across time, a detailed manual of procedures for each experimental group will be developed and used for staff training.
Data analysis: All analyses will follow the intent to treat principle. The principle investigator will lead all analyses with support from collaborators on WMH quantification and structural MRI analyses. The intention-to-treat analysis will be conducted with multiple imputation followed by a complete-case analysis. Statistical significance for all analyses will be defined at α < 0.05.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Chun Liang HSU, PhD
- 电话号码:852-27666755
- 邮箱:chun-liang.hsu@polyu.edu.hk
学习地点
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Hong Kong
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Hong Kong、Hong Kong、香港、0000000
- 招聘中
- The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
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接触:
- Chun Liang HSU, PhD
- 电话号码:27666755
- 邮箱:chun-liang.hsu@polyu.edu.hk
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- are community-dwelling (i.e., not residing in a nursing home or extended care unit) ;
- scored < 9/12 on the SPPB;
- scored >18/30 on the MoCA;
- are able to walk independently; use of walking aid is acceptable;
- are able to safely engage in exercise as indicated by the Physical Activity Readiness Questionnaire Plus33 and confirmed by their physician;
- have internet at home; and
- are able to provide written informed consent.
Exclusion Criteria:
- diagnosed with dementia or stroke;
- self-report engaging in strength and balance training exercises > two-times-per-week in the 3 months prior to screening;
- unable to understand, speak, and read Cantonese/Chinese/English proficiently; and
- contraindications for MRI such as MRI-incompatible implants.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Aerobic and resistance training
Participants will complete two aerobic training sessions and two resistance training sessions per week for a total of four exercise training sessions each week lasting for 3-month (i.e., 13-weeks). Aerobic exercise intensity will be tracked through heart-rate monitors with an age-specific targeted heart-rate-reserve initially set at 50% and progressively increased by 5% weekly until 70% heart-rate-reserve is reached in Week-5, then it will be sustained for the remainder of the trial. The first four weeks of the resistance training program will emphasize on assisting the study participants in gaining familiarity with proper technique. The intensity of the resistance training stimulus will be set to a weight where the participants can complete two sets of 10-15 repetitions, then progressed from 45% to 85% of predicted 1-repetition-maximum determined at Week-4 using the 8-rep maximum test. The 8-rep maximum test is rrepeated every 4 weeks to ensure the exercise intensity is maintained |
The aerobic training sessions will involve standardized sets of stationary training, including on-spot jogging, burpees, aerobic steppers, agility ladders, and non-contact boxing. Each participant will rotate through the stations within the 40-minute training period, with one-minute of rest breaks in-between each station. A 20-point rate-of-perceived exertion will be used to monitor participant status during training with a target rate-of-perceived exertion of 16-17. The resistance training sessions will involve utilizing free weights and resistance bands to stimulate muscle strength. The set of movements include triceps extension, dumbbell bicep curls, seated overhead dumbbell press, bent-over dumbbell row, wall squats, standing calf raises, wall push-ups. |
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安慰剂比较:Usual care
Participant Retention and Care: Investigator will implement strategies to promote participant retention by: (1) conducting monthly phone calls by the project assistant to encourage and motivate participants to stay within the study; (2) discussing participant barriers/distress and developing coping/action plans; (3) providing monthly updates in the form of in-person/online/phone sessions; and (4) offering a comprehensive report on cognitive function, mobility, brain MRI, and monetary compensation for their time upon completion of the study. Investigator will facilitate participant care by recording incidental findings from the MRI and providing clinical assessment data that may be shared with healthcare providers upon request. All personnel on the research team will be trained to detect/assess distress or any possibility of harm and respond appropriately. |
Participant Retention and Care: Investigator will implement strategies to promote participant retention by: (1) conducting monthly phone calls by the project assistant to encourage and motivate participants to stay within the study; (2) discussing participant barriers/distress and developing coping/action plans; (3) providing monthly updates in the form of in-person/online/phone sessions; and (4) offering a comprehensive report on cognitive function, mobility, brain MRI, and monetary compensation for their time upon completion of the study. Investigator will facilitate participant care by recording incidental findings from the MRI and providing clinical assessment data that may be shared with healthcare providers upon request. All personnel on the research team will be trained to detect/assess distress or any possibility of harm and respond appropriately. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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30 seconds sit-to-stand test
大体时间:Baseline and 3 months
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Mobility |
Baseline and 3 months
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Quantification of physical reserve
大体时间:Baseline and 3 months
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Physical reserve will be operationally defined as the unexplained residual variance in 30-second Sit-to-Stand Test after accounting for the effects of age, cognitive capacity, and brain structural integrity. |
Baseline and 3 months
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Alzheimer's Disease Assessment Scale-Cognitive-13
大体时间:Baseline and 3 months
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Cognitive capacity will be assessed by the Alzheimer's Disease Assessment Scale-Cognitive-13. It measures memory, language, praxis, attention, and executive function, with scores ranging from 0 to 85; higher scores indicate greater cognitive impairment. |
Baseline and 3 months
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Total hippocampal volume
大体时间:Baseline and 3 months
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Total hippocampal volume will be selected to reflect brain structural integrity |
Baseline and 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Trail Making Test
大体时间:Baseline and 3 months
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The Trail Making Test will comprise Part A and Part B. In Part A, participants are instructed to connect numbers in sequential order (e.g., drawing a line from 1 to 2, 2 to 3, 3 to 4, etc.) while being timed. In Part B, participants are instructed to connect, in order, 25 encircled numbers and letters alternately (e.g., 1-A-2-B-3-C) while being timed. A longer time represents worse executive function. |
Baseline and 3 months
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Resting state functional connectivity
大体时间:Baseline and 3 months
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Functional MRI will be used to measure resting state functional connectivity |
Baseline and 3 months
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Education
大体时间:Baseline and 3 months
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Years of education of participants will be recorded |
Baseline and 3 months
|
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Physical Activity Scale for the EAlderly
大体时间:Baseline and 3 months
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Physical activity will be assessed by the Physical Activity Scale for the Elderly. Higher scores represent better physical activity. |
Baseline and 3 months
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Body mass index
大体时间:Baseline and 3 months
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Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²). |
Baseline and 3 months
|
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Pictorial Fit-Frail Scale
大体时间:Baseline and 3 months
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Physical frailty will be assessed by the Pictorial Fit-Frail Scale. It involves 14 domains, with scores ranging from 0 to 43; higher scores indicate severely frail. |
Baseline and 3 months
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Short Physical Performance Battery
大体时间:Baseline and 3 months
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Physical frailty will be measured by the Short Physical Performance Battery. It measures balance, walking, and sit to stand, with scores ranging from 0 to 12; higher scores indicate greater mobility. |
Baseline and 3 months
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The Montreal Cognitive Assessment
大体时间:Baseline and 3 months
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General cognitive function will be assessed by the Montreal Cognitive Assessment. It measures memory, language, visuospatial, attention, and abstract reasoning, with scores ranging from 0 to 30; higher scores indicate greater general cognition. |
Baseline and 3 months
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Functional Comorbidity Index
大体时间:Baselin and 3 months
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Total number of comorbid conditions will be assessed through the Functional Comorbidity Index , with a maximum score of 18. A lower score indicates fewer comorbidities. |
Baselin and 3 months
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Sleep duration
大体时间:Baselin and 3 months
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Sleep duration will be recorded in hours over the last 24 hours and the last 7 days. |
Baselin and 3 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- HSEARS20250709003
- 25603525 (其他赠款/资助编号:Research Grants Council, Hong Kong SAR)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Investigators will create a de-identified dataset to share at the time of publishing the primary results of our trial or within 9 months of database lock, whichever comes first. The data to be shared include but not limited to: de-identified instrument item and total scores of primary and secondary outcomes; de-identified exercise session report data
IPD 共享时间框架
Dec 2028
IPD 共享访问标准
a commitment to using the data only for research purposes and not to identify an individual participant; a commitment to securing the data using appropriate computer technology; a commitment to destroying or returning the data after analyses are completed; all data sharing requests must be reviewed and approved by the PI.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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