- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07566832
Velocity-Based Resistance Training Effects on Inflammation in Older Adults
2026. május 4. frissítette: 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.
A tanulmány áttekintése
Állapot
Toborzás
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
60
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Shun-Hsi Tsai, Ph.D.
- Telefonszám: 68523 +88686741111
- E-mail: shunhsi@mail.ntpu.edu.tw
Tanulmányi helyek
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Taipei, Tajvan, 116
- Toborzás
- National Taiwan Normal University
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Kapcsolatba lépni:
- Hung-Wen Liu, Ph.D.
- Telefonszám: +88677496863
- E-mail: hwliu@ntnu.edu.tw
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Kapcsolatba lépni:
- Kuan-Tsen Yeh, M.S.
- Telefonszám: +886932815383
- E-mail: mickyyehyeh@gmail.com
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Igen
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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.
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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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Kísérleti: 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.
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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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Kísérleti: 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.
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Nincs beavatkozás: sedentary control
Participants in control trial stayed sedentary during the period.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Changes in IL-6 concentration
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Borgs Ratings of Perceived Exertion (RPE)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Shun-Hsi Tsai, Ph.D., National Taipei University
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2026. április 20.
Elsődleges befejezés (Becsült)
2029. március 1.
A tanulmány befejezése (Becsült)
2029. december 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. április 15.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. április 28.
Első közzététel (Tényleges)
2026. május 5.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. május 8.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 4.
Utolsó ellenőrzés
2026. április 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Motoros aktivitás
- Mozgás
- Izom -csontrendszeri fiziológiai jelenség
- Izom -csontrendszeri és idegi fiziológiai jelenség
- Terápiás kezelés
- Fizikoterápiás módszerek
- Beteggondozás
- Gyakorlatterápia
- Rehabilitáció
- Utógondozás
- A betegellátás folytonossága
- Fizikai kondicionálás, ember
- Gyakorlat
- Ellenállási edzés
Egyéb vizsgálati azonosító számok
- ECKIRB1140803
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
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Nem
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