- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07566832
Velocity-Based Resistance Training Effects on Inflammation in Older Adults
4 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
60
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Shun-Hsi Tsai, Ph.D.
- Numero di telefono: 68523 +88686741111
- Email: shunhsi@mail.ntpu.edu.tw
Luoghi di studio
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-
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Taipei, Taiwan, 116
- Reclutamento
- National Taiwan Normal University
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Contatto:
- Hung-Wen Liu, Ph.D.
- Numero di telefono: +88677496863
- Email: hwliu@ntnu.edu.tw
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Contatto:
- Kuan-Tsen Yeh, M.S.
- Numero di telefono: +886932815383
- Email: mickyyehyeh@gmail.com
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Nessun intervento: sedentary control
Participants in control trial stayed sedentary during the period.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Changes in IL-6 concentration
Lasso di tempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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
Lasso di tempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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
Lasso di tempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Borgs Ratings of Perceived Exertion (RPE)
Lasso di tempo: 1-hour during each exercise intervention
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Shun-Hsi Tsai, Ph.D., National Taipei University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
20 aprile 2026
Completamento primario (Stimato)
1 marzo 2029
Completamento dello studio (Stimato)
1 dicembre 2029
Date di iscrizione allo studio
Primo inviato
15 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
28 aprile 2026
Primo Inserito (Effettivo)
5 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 maggio 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Attività motoria
- Movimento
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Terapie
- Modalità di terapia fisica
- Cura del paziente
- Terapia di esercizio
- Riabilitazione
- Assistenza post -terapia
- Continuità della cura del paziente
- Condizionamento fisico, umano
- Esercizio
- Allenamento di resistenza
Altri numeri di identificazione dello studio
- ECKIRB1140803
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .