HIIT 对慢性中风患者骨代谢的影响
高强度间歇训练对慢性中风患者骨代谢的影响：概念验证、随机对照试验
Objectives: To investigate the effects of high-intensity interval training (HIIT) on musculoskeletal fitness in chronic stroke survivors.
Hypothesis to be tested: HIIT, performed on a recumbent stepper, will significantly enhance muscle power in chronic stroke survivors when compared with moderate-intensity continuous training (MICT) Design and subjects: Assessor-blinded, stratified, randomised, placebo-controlled clinical trial involving eligible 66 chronic stroke survivors.
Interventions: Participants will be randomly allocated to one of three groups: the HIIT group, the MICT group, or a stretching group (active control). Each group will attend sessions three times per week for 12 consecutive weeks, totaling 36 training sessions.
Main outcome measures: Assessments will be conducted at baseline, at mid-term of the intervention (week 6), at the end of the intervention (week 12), and at a 12-week follow-up (week 24). The primary outcome measure will be muscle power. Secondary outcome measures will include muscle strength, body composition, biomarkers, motor function, balance function, cardiorespiratory response, and psychosocial response.
研究概览
地位
地位
干预/治疗
干预/治疗
研究类型
研究类型
注册 (估计的)
注册
阶段
阶段
- 不适用
联系人和位置
学习联系方式
学习联系方式
- 姓名：Chen Xu, PhD student
- 电话号码：00000000
- 邮箱：rschen.xu@connect.polyu.hk
研究联系人备份
- 姓名：Meizhen Huang, PhD
- 电话号码：00000000
- 邮箱：mei-zhen.huang@polyu.edu.hk
学习地点
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-
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Kowloon、香港
- 招聘中
- The Hong Kong Polytechnic University
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接触：
- Meizhen Huang, PhD
- 邮箱：mei-zhen.huang@polyu.edu.hk
-
接触：
- Chen Xu, PhD student
- 邮箱：rschen.xu@connect.polyu.hk
-
-
参与标准
资格标准
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:
- Men and postmenopausal women aged 50-80 years
- 1-5 years following the first-ever stroke confirmed by magnetic resonance imaging or computed tomography
- Able to walk 10 meters independently with or without a walking aid
- Class I or II according to the New York Heart Association Functional Classification (no limitation or slight limitation of physical activity due to symptoms during ordinary physical activity)
Exclusion criteria:
- Presence of other neurological comorbidities, significant liver or renal diseases, thyroid or parathyroid diseases, rheumatoid arthritis, or a fracture within the past 6 months
- Undergoing osteoporosis treatments within the past 3 years, use of oral corticosteroids for more than 3 months within the past year, or botulinum toxin injections in the paretic lower limb within the past 6 months
- Participation in ongoing stroke rehabilitation services or structured exercise programme
- Cognitive or communication issues that could limit the ability to follow instructions
- Contraindications to HIIT, graded exercise testing, or failure to pass medical clearance from a specialist
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
手臂数量
武器和干预
参与者组/臂参与者组/臂 |
干预/治疗干预/治疗 |
|---|---|
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实验性的：High-intensity interval training
The HIIT session will consist of a 3-minute warm-up, a 20-minute main exercise, and a 2-minute cool-down. The main exercise for HIIT will include ten high-intensity intervals, interspersed with ten low-intensity intervals. |
There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions. |
|
有源比较器：Moderate-intensity continuous training
The MICT session will consist of a 3-minute warm-up, a main exercise that approximately matches the total workload of the HIIT session (lasting about 30 minutes), and a 2-minute cool-down. The intensity during the main exercise for MICT will remain below the vigorous level by progressively adjusting the workload throughout the intervention period. |
There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions. |
|
有源比较器：Stretching
The stretching group will receive 25 minutes of whole-body stretching. |
There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions. |
研究衡量的是什么？
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in Muscle Power at Week 12
大体时间：Baseline and Week 12
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Muscle power (watt) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 12 Level - Baseline Level) |
Baseline and Week 12
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次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in Muscle Power at Week 24
大体时间：Baseline and Week 24
|
Muscle power (watt) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 24 Level - Baseline Level) |
Baseline and Week 24
|
|
Change from Baseline in Muscle Strength (Nm) at Week 12
大体时间：Baseline and Week 12
|
Muscle strength (Nm) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 12 Level - Baseline Level) |
Baseline and Week 12
|
|
Change from Baseline in Muscle Strength (Nm) at Week 24
大体时间：Baseline and Week 24
|
Muscle strength (Nm) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 24 Level - Baseline Level) |
Baseline and Week 24
|
|
Change from Baseline in Muscle Strength (kg) at Week 12
大体时间：Baseline and Week 12
|
Handgrip strength (kg) on both sides will be measured using a handheld dynamometer. Change=(Week 12 Level - Baseline Level) |
Baseline and Week 12
|
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Change from Baseline in Muscle Strength (kg) at Week 24
大体时间：Baseline and Week 24
|
Handgrip strength (kg) on both sides will be measured using a handheld dynamometer. Change=(Week 24 Level - Baseline Level) |
Baseline and Week 24
|
|
Change from Baseline in Body Composition (kg) at Week 12
大体时间：Baseline and Week 12
|
Whole-body skeletal muscle mass (kg), bone mineral content (kg), fat mass (kg), and segmental lean mass (kg) will be measured using bioelectrical impedance analysis (BIA). Change=(Week 12 Level - Baseline Level) |
Baseline and Week 12
|
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Change from Baseline in Body Composition (kg) at Week 24
大体时间：Baseline and Week 24
|
Whole-body skeletal muscle mass (kg), bone mineral content (kg), fat mass (kg), and segmental lean mass (kg) will be measured using bioelectrical impedance analysis (BIA). Change=(Week 24 Level - Baseline Level) |
Baseline and Week 24
|
|
Change from Baseline in Body Composition (%) at Week 12
大体时间：Baseline and Week 12
|
Body fat percentage (%) will be measured using bioelectrical impedance analysis (BIA). Change=(Week 12 Level - Baseline Level) |
Baseline and Week 12
|
|
Change from Baseline in Body Composition (%) at Week 24
大体时间：Baseline and Week 24
|
Body fat percentage (%) will be measured using bioelectrical impedance analysis (BIA). Change=(Week 24 Level - Baseline Level) |
Baseline and Week 24
|
|
Change from Baseline in Biomarkers at Week 12
大体时间：Baseline and Week 12
|
Volume-corrected serum concentration (mg/dL) of myokines, bone markers, pro-inflammatory markers, biomarkers of oxidative stress will be measured using enzyme-linked immunosorbent assay (ELISA) kits. Change=(Week 12 Level - Baseline Level) |
Baseline and Week 12
|
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Change from Baseline in Biomarkers at Week 6
大体时间：Baseline and Week 6
|
Volume-corrected serum concentration (mg/dL) of myokines, bone markers, pro-inflammatory markers, biomarkers of oxidative stress will be measured using enzyme-linked immunosorbent assay (ELISA) kits. Change=(Week 6 Level - Baseline Level) |
Baseline and Week 6
|
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Change from Baseline in Motor Function at Week 12
大体时间：Baseline and Week 12
|
Fugl-Meyer Motor Assessment (FMA) will be used to assess the degree of motor recovery of the hemiparetic upper (range: 0-66) and lower limbs (range: 0-34). Higher scores are indicative of better motor recovery. Short Physical Performance Battery (SPPB) will be used to assess the physical performance, including 5-times sit-to-stand, balance tests (side-by-side-stand, semi-tandem stand, and tandem stand), and gait speed. Change=(Week 12 Score- Baseline Score) |
Baseline and Week 12
|
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Change from Baseline in Motor Function at Week 24
大体时间：Baseline and Week 24
|
Fugl-Meyer Motor Assessment (FMA) will be used to assess the degree of motor recovery of the hemiparetic upper (range: 0-66) and lower limbs (range: 0-34). Higher scores are indicative of better motor recovery. Short Physical Performance Battery (SPPB) will be used to assess the physical performance, including 5-times sit-to-stand, balance tests (side-by-side-stand, semi-tandem stand, and tandem stand), and gait speed. Change=(Week 24 Score- Baseline Score) |
Baseline and Week 24
|
|
Change from Baseline in Motor Function (meters) at Week 12
大体时间：Baseline and Week 12
|
The 6-minute walk test (6MWT) will be used to measure walking endurance and capacity. The total distance walked in meters during the test will be recorded. Change=(Week 12 distance - Baseline distance) |
Baseline and Week 12
|
|
Change from Baseline in Motor Function (meters) at Week 24
大体时间：Baseline and Week 24
|
The 6-minute walk test (6MWT) will be used to measure walking endurance and capacity. The total distance walked in meters during the test will be recorded. Change=(Week 24 distance - Baseline distance) |
Baseline and Week 24
|
|
Change from Baseline in Balance Function at Week 12
大体时间：Baseline and Week 12
|
Balance performance will be assessed using the Mini Balance Evaluation Systems Test (range: 0-28). Higher scores are indicative of better balance performance. Fear of falling will be assessed using the Chinese version of the Activities-Specific Balance Confidence Scale (range: 0-100). Higher scores are indicative of higher balance confidence. Change=(Week 12 Score- Baseline Score) |
Baseline and Week 12
|
|
Change from Baseline in Balance Function at Week 24
大体时间：Baseline and Week 24
|
Balance performance will be assessed using the Mini Balance Evaluation Systems Test (range: 0-28). Higher scores are indicative of better balance performance. Fear of falling will be assessed using the Chinese version of the Activities-Specific Balance Confidence Scale (range: 0-100). Higher scores are indicative of higher balance confidence. Change=(Week 24 Score- Baseline Score) |
Baseline and Week 24
|
|
Change from Baseline in Cardiopulmonary Response at Week 12
大体时间：Baseline and Week 12
|
Peak oxygen uptake (VO2peak) will be measured using a graded exercise test (GXT). The GXT will be conducted following a well-validated protocol that on a whole-body recumbent stepper to assess cardiopulmonary function in stroke patients. Change=(Week 12 VO2peak - Baseline VO2peak) |
Baseline and Week 12
|
|
Change from Baseline in Cardiopulmonary Response at Week 24
大体时间：Baseline and Week 24
|
Peak oxygen uptake (VO2peak) will be measured using a graded exercise test (GXT). The GXT will be conducted following a well-validated protocol that on a whole-body recumbent stepper to assess cardiopulmonary function in stroke patients. Change=(Week 24 VO2peak - Baseline VO2peak) |
Baseline and Week 24
|
|
Change from Baseline in Psychosocial Responses at Week 12
大体时间：Baseline and Week 12
|
Post-stroke fatigue will be assessed using the Fatigue Severity Scale (range: 1-7). Higher scores are indicative of more severe fatigue. Health-related quality of life will be assessed using 12-Item Short Form Health Survey (range: 0-100). Higher scores are indicative of better quality of life. Exercise enjoyment will be assessed by the Physical Activity Enjoyment Scale and Behavioural Regulation Exercise Questionnaire-3 (range: 0-400). Higher scores indicate a higher exercise enjoyment level. Motivation for exercise will be assessed using the Behavioural Regulation Exercise Questionnaire-3 (range: 0-96). Higher scores indicate more motivation to exercise. A semi-structured interview will be additionally conducted at the end of the intervention (week 12) to explore the experiences of HIIT in stroke patients. Change=(Week 12 Score - Baseline Score) |
Baseline and Week 12
|
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Change from Baseline in Psychosocial Responses at Week 24
大体时间：Baseline and Week 24
|
Post-stroke fatigue will be assessed using the Fatigue Severity Scale (range: 1-7). Higher scores are indicative of more severe fatigue. Health-related quality of life will be assessed using 12-Item Short Form Health Survey (range: 0-100). Higher scores are indicative of better quality of life. Exercise enjoyment will be assessed by the Physical Activity Enjoyment Scale and Behavioural Regulation Exercise Questionnaire-3 (range: 0-400). Higher scores indicate a higher exercise enjoyment level. Motivation for exercise will be assessed using the Behavioural Regulation Exercise Questionnaire-3 (range: 0-96). Higher scores indicate more motivation to exercise. A semi-structured interview will be additionally conducted at the end of the intervention (week 12) to explore the experiences of HIIT in stroke patients. Change=(Week 24 Score - Baseline Score) |
Baseline and Week 24
|
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)
学习开始
初级完成 (估计的)
初级完成
研究完成 (估计的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (实际的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
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