慢性脳卒中患者の骨代謝に対する HIIT の影響
慢性脳卒中患者の骨代謝に対する高強度インターバルトレーニングの効果：概念実証、ランダム化比較試験
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Chen Xu, PhD student
- 電話番号：00000000
- メール：rschen.xu@connect.polyu.hk
研究連絡先のバックアップ
- 名前：Meizhen Huang, PhD
- 電話番号：00000000
- メール：mei-zhen.huang@polyu.edu.hk
研究場所
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Kowloon、香港
- 募集
- The Hong Kong Polytechnic University
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コンタクト：
- Meizhen Huang, PhD
- メール：mei-zhen.huang@polyu.edu.hk
-
コンタクト：
- Chen Xu, PhD student
- メール：rschen.xu@connect.polyu.hk
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-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
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実験的：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. |
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アクティブコンパレータ：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. |
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アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in Muscle Power at Week 12
時間枠：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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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Muscle Power at Week 24
時間枠：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
時間枠：Baseline and Week 12
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
|
Change from Baseline in Body Composition (kg) at Week 24
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline and Week 6
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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
時間枠：Baseline and Week 12
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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
時間枠：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
時間枠：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
|
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Change from Baseline in Motor Function (meters) at Week 24
時間枠：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
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Change from Baseline in Balance Function at Week 12
時間枠：Baseline and Week 12
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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
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Change from Baseline in Balance Function at Week 24
時間枠：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
|
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Change from Baseline in Cardiopulmonary Response at Week 12
時間枠：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
|
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Change from Baseline in Cardiopulmonary Response at Week 24
時間枠：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
|
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Change from Baseline in Psychosocial Responses at Week 12
時間枠：Baseline and Week 12
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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
時間枠：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
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- HSEARS20230720002
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