A HIIT hatása a krónikus stroke-ban szenvedő egyének csontanyagcseréjére
A nagy intenzitású intervallum edzés hatásai a krónikus stroke-ban szenvedő egyének csontanyagcseréjére: elméleti bizonyíték, randomizált, kontrollált vizsgálat
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.
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Chen Xu, PhD student
- Telefonszám: 00000000
- E-mail: rschen.xu@connect.polyu.hk
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Meizhen Huang, PhD
- Telefonszám: 00000000
- E-mail: mei-zhen.huang@polyu.edu.hk
Tanulmányi helyek
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Kowloon, Hong Kong
- Toborzás
- The Hong Kong Polytechnic University
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Kapcsolatba lépni:
- Meizhen Huang, PhD
- E-mail: mei-zhen.huang@polyu.edu.hk
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Kapcsolatba lépni:
- Chen Xu, PhD student
- E-mail: rschen.xu@connect.polyu.hk
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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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Aktív összehasonlító: 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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Aktív összehasonlító: 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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Change from Baseline in Muscle Power at Week 12
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change from Baseline in Muscle Power at Week 24
Időkeret: Baseline and Week 24
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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 24 Level - Baseline Level) |
Baseline and Week 24
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Change from Baseline in Muscle Strength (Nm) at Week 12
Időkeret: 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
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Change from Baseline in Muscle Strength (Nm) at Week 24
Időkeret: Baseline and Week 24
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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 24 Level - Baseline Level) |
Baseline and Week 24
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Change from Baseline in Muscle Strength (kg) at Week 12
Időkeret: Baseline and Week 12
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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
Időkeret: Baseline and Week 24
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Handgrip strength (kg) on both sides will be measured using a handheld dynamometer. Change=(Week 24 Level - Baseline Level) |
Baseline and Week 24
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Change from Baseline in Body Composition (kg) at Week 12
Időkeret: Baseline and Week 12
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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
Időkeret: Baseline and Week 24
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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
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Change from Baseline in Body Composition (%) at Week 12
Időkeret: Baseline and Week 12
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Body fat percentage (%) 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 (%) at Week 24
Időkeret: Baseline and Week 24
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Body fat percentage (%) will be measured using bioelectrical impedance analysis (BIA). Change=(Week 24 Level - Baseline Level) |
Baseline and Week 24
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Change from Baseline in Biomarkers at Week 12
Időkeret: Baseline and Week 12
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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 12 Level - Baseline Level) |
Baseline and Week 12
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Change from Baseline in Biomarkers at Week 6
Időkeret: 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
Időkeret: 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
Időkeret: Baseline and Week 24
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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 24 Score- Baseline Score) |
Baseline and Week 24
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Change from Baseline in Motor Function (meters) at Week 12
Időkeret: Baseline and Week 12
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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
Időkeret: Baseline and Week 24
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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
Időkeret: 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
Időkeret: Baseline and Week 24
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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 24 Score- Baseline Score) |
Baseline and Week 24
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Change from Baseline in Cardiopulmonary Response at Week 12
Időkeret: Baseline and Week 12
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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
Időkeret: Baseline and Week 24
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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
Időkeret: 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
Időkeret: Baseline and Week 24
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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 24 Score - Baseline Score) |
Baseline and Week 24
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Cerebrovaszkuláris rendellenességek
- Agyi betegségek
- Központi idegrendszeri betegségek
- Idegrendszeri betegségek
- Érrendszeri betegségek
- Szív-és érrendszeri betegségek
- Stroke
- Motoros aktivitás
- Mozgás
- Izom -csontrendszeri fiziológiai jelenség
- Izom -csontrendszeri és idegi fiziológiai jelenség
- Fizikai kondicionálás, ember
- Gyakorlat
- Nagy intenzitású intervallum edzés
Egyéb vizsgálati azonosító számok
- HSEARS20230720002
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