- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07566832
Velocity-Based Resistance Training Effects on Inflammation in Older Adults
4. května 2026 aktualizováno: National Taipei University
Dose-Response Effects of Velocity-Based Resistance Training on Anti-Inflammatory Responses in Older Adults
This study aims to investigate the effects of resistance training (RT) with different training volumes on immune modulation and anti-inflammatory responses in older adults.
Participants will be randomly assigned to one of three RT volume groups (low, medium, or high) or a non-exercise control group.
Participants in the training groups will complete a 4-week RT program, followed by a 4-week detraining phase.
The findings are expected to provide evidence for volume-specific RT prescriptions to support healthy aging.
Přehled studie
Typ studie
Intervenční
Zápis (Odhadovaný)
60
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
- Jméno: Shun-Hsi Tsai, Ph.D.
- Telefonní číslo: 68523 +88686741111
- E-mail: shunhsi@mail.ntpu.edu.tw
Studijní místa
-
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Taipei, Tchaj-wan, 116
- Nábor
- National Taiwan Normal University
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Kontakt:
- Hung-Wen Liu, Ph.D.
- Telefonní číslo: +88677496863
- E-mail: hwliu@ntnu.edu.tw
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Kontakt:
- Kuan-Tsen Yeh, M.S.
- Telefonní číslo: +886932815383
- E-mail: mickyyehyeh@gmail.com
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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
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
Inclusion Criteria:
- Aged 60-75 years or older
- No regular resistance training habit (defined as ≥2 sessions per week) in the past year
- No musculoskeletal injuries within the past six months
Exclusion Criteria:
- Obesity (BMI > 30 kg/m²), diabetes, hypertension, cancer, heart, kidney, or liver disease, or any other condition that may influence study outcomes.
- Regular use of anti-inflammatory medications (e.g., NSAIDs).
- Smoking or alcohol abuse
- Inability to safely perform the prescribed resistance exercise movements
- Unable to fully comprehend the study information and instructions.
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: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: low training volume resistance exercise
Participants assigned to the low-volume resistance training group will perform one set per exercise at a load corresponding to 80% of 1RM.
Each set will be terminated when movement velocity decreases by 30% from the first repetition.
Rest intervals of 2-3 minutes will be provided between exercises.
|
The RT program will consist of 12 sessions over a 4-week period, with participants training three times per week and at least one rest day between sessions.
All sessions will be supervised by research personnel to ensure proper technique and safety.
Exercises will be performed using resistance machines and will include chest press, shoulder press, seated row, lat pulldown, and leg press.
|
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Experimentální: medium training volume resistance exercise
Participants assigned to the medium-volume resistance training group will perform three sets per exercise at 80% of 1RM.
Each set will be terminated when movement velocity decreases by 30% relative to the first repetition.
Rest intervals of 90 seconds will be provided between sets, and 2-3 minutes between exercises.
|
The RT program will consist of 12 sessions over a 4-week period, with participants training three times per week and at least one rest day between sessions.
All sessions will be supervised by research personnel to ensure proper technique and safety.
Exercises will be performed using resistance machines and will include chest press, shoulder press, seated row, lat pulldown, and leg press.
|
|
Experimentální: high training volume resistance exercise
Participants assigned to the high-volume resistance training group will perform five sets per exercise at 80% of 1RM.
Each set will be terminated when movement velocity decreases by 30% relative to the first repetition.
Rest intervals of 90 seconds will be provided between sets, and 2-3 minutes between exercises.
|
The RT program will consist of 12 sessions over a 4-week period, with participants training three times per week and at least one rest day between sessions.
All sessions will be supervised by research personnel to ensure proper technique and safety.
Exercises will be performed using resistance machines and will include chest press, shoulder press, seated row, lat pulldown, and leg press.
|
|
Žádný zásah: sedentary control
Participants in control trial stayed sedentary during the period.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Changes in IL-6 concentration
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Plasma IL-6 concentrations will be measured and reported in pg/mL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in soluble IL-6 receptor concentration
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Soluble IL-6 receptor concentrations will be measured and reported in ng/mL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in soluble gp130 concentration
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Soluble gp130 concentrations will be measured and reported in ng/mL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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Changes in IL-10 concentration
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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IL-10 concentrations will be measured and reported in pg/mL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in IL-1RA concentration
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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IL-1RA concentrations will be measured and reported in pg/mL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in TNF-α concentration
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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TNF-α concentrations will be measured and reported in pg/mL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Borgs Ratings of Perceived Exertion (RPE)
Časové okno: 1-hour during each exercise intervention
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Borgs RPE is a method of estimating exertion rating, based on a 1 to 10 rating scale (1 being the no exertion at all, 10 being maximal exertion).
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1-hour during each exercise intervention
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Handgrip strength
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Maximal handgrip strength will be assessed using a digital hand dynamometer and reported in kilograms.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Knee extension strength
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Maximal voluntary isometric and isokinetic concentric knee extension strength of the dominant leg will be assessed using an isokinetic dynamometer and reported in Newton-meters.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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30-second chair-stand test
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Lower-body functional capacity will be assessed by the number of repetitions completed during a 30-second chair-stand test.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Single-leg balance test
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Balance performance will be assessed as the duration of single-leg stance and reported in seconds.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Timed up and go test
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Functional mobility will be assessed using the Timed Up and Go test, with performance quantified as the time (seconds) required to stand up from a seated position, walk 3 meters, turn, walk back, and sit down.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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Changes in SHIP1 protein expression in peripheral blood mononuclear cells (PBMCs)
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Intracellular SHIP1 protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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Changes in gp130 (CD130) protein expression in PBMCs
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Intracellular gp130 (CD130) protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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Changes in STAT3 protein expression in PBMCs
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Intracellular STAT3 protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in phosphorylated STAT3 protein expression in PBMCs
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Intracellular phosphorylated STAT3 (p-STAT3) protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in IL-6 receptor alpha (CD126) protein expression in PBMCs
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Intracellular IL-6 receptor alpha (CD126) protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in Beta-2 adrenergic receptor (β2-AR) protein expression in PBMCs
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Intracellular β2-adrenergic receptor (β2-AR) protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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Changes in SOCS3 protein expression in PBMCs
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Intracellular SOCS3 protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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Changes in white blood cell count
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Total white blood cell count will be measured and reported in cells/μL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in lymphocyte count
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Lymphocyte count will be measured and reported in cells/μL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in neutrophil count
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Neutrophil count will be measured and reported in cells/μL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in monocyte count
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Monocyte count will be measured and reported in cells/μL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Body fat percentage
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Body fat percentage will be measured using a body composition analyzer and reported as a percentage.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Lean body mass
Časové okno: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Total lean body mass will be measured using a body composition analyzer and reported in kilograms.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Shun-Hsi Tsai, Ph.D., National Taipei 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. dubna 2026
Primární dokončení (Odhadovaný)
1. března 2029
Dokončení studie (Odhadovaný)
1. prosince 2029
Termíny zápisu do studia
První předloženo
15. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
28. dubna 2026
První zveřejněno (Aktuální)
5. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
4. května 2026
Naposledy ověřeno
1. dubna 2026
Více informací
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