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Účinky HIIT na kostní metabolismus u jedinců s chronickou mrtvicí

17. září 2026 aktualizováno: The Hong Kong Polytechnic University

Účinky vysoce intenzivního intervalového tréninku na kostní metabolismus u jedinců s chronickou mrtvicí: ověřená koncepce, randomizovaná kontrolovaná studie

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

66

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

50 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: High-intensity Interval Training

There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
Aktivní komparátor: 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.
Behaviorální: Moderate-Intensity Continuous Training

There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
Aktivní komparátor: Stretching

The stretching group will receive 25 minutes of whole-body stretching.
Behaviorální: Stretching

There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline in Muscle Power at Week 12
Časové okno: Baseline and Week 12

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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline in Muscle Power at Week 24
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Change from Baseline in Muscle Strength (kg) at Week 24
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Change from Baseline in Biomarkers at Week 6
Časové okno: 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
Change from Baseline in Motor Function at Week 12
Časové okno: 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
Change from Baseline in Motor Function at Week 24
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Change from Baseline in Psychosocial Responses at Week 24
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The Hong Kong Polytechnic University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

20. srpna 2024

Primární dokončení (Odhadovaný)

5. srpna 2027

Dokončení studie (Odhadovaný)

5. srpna 2027

Termíny zápisu do studia

První předloženo

30. července 2024

První předloženo, které splnilo kritéria kontroly kvality

14. srpna 2024

První zveřejněno (Aktuální)

15. srpna 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. září 2026

Naposledy ověřeno

1. září 2025

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • HSEARS20230720002

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Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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