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Wpływ HIIT na metabolizm kości u osób z przewlekłym udarem mózgu

17 września 2026 zaktualizowane przez: The Hong Kong Polytechnic University

Wpływ treningu interwałowego o wysokiej intensywności na metabolizm kości u osób z przewlekłym udarem mózgu: randomizowane badanie kontrolowane potwierdzające słuszność koncepcji

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

66

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

50 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: High-intensity Interval Training

There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
Aktywny komparator: 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.
Behawioralne: Moderate-Intensity Continuous Training

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

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

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Muscle Power at Week 12
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Muscle Power at Week 24
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The Hong Kong Polytechnic University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 sierpnia 2024

Zakończenie podstawowe (Szacowany)

5 sierpnia 2027

Ukończenie studiów (Szacowany)

5 sierpnia 2027

Daty rejestracji na studia

Pierwszy przesłany

30 lipca 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 sierpnia 2024

Pierwszy wysłany (Rzeczywisty)

15 sierpnia 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 września 2026

Ostatnia weryfikacja

1 września 2025

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • HSEARS20230720002

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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