- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07566832
Velocity-Based Resistance Training Effects on Inflammation in Older Adults
4. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Shun-Hsi Tsai, Ph.D.
- Telefonnummer: 68523 +88686741111
- E-post: shunhsi@mail.ntpu.edu.tw
Studiesteder
-
-
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Taipei, Taiwan, 116
- Rekruttering
- National Taiwan Normal University
-
Ta kontakt med:
- Hung-Wen Liu, Ph.D.
- Telefonnummer: +88677496863
- E-post: hwliu@ntnu.edu.tw
-
Ta kontakt med:
- Kuan-Tsen Yeh, M.S.
- Telefonnummer: +886932815383
- E-post: mickyyehyeh@gmail.com
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Ingen inngripen: sedentary control
Participants in control trial stayed sedentary during the period.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in IL-6 concentration
Tidsramme: 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.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in soluble IL-6 receptor concentration
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Soluble IL-6 receptor concentrations will be measured and reported in ng/mL.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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Changes in soluble gp130 concentration
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Soluble gp130 concentrations will be measured and reported in ng/mL.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in IL-10 concentration
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
IL-10 concentrations will be measured and reported in pg/mL.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in IL-1RA concentration
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
IL-1RA concentrations will be measured and reported in pg/mL.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in TNF-α concentration
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
TNF-α concentrations will be measured and reported in pg/mL.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Borgs Ratings of Perceived Exertion (RPE)
Tidsramme: 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).
|
1-hour during each exercise intervention
|
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Handgrip strength
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
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.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in SHIP1 protein expression in peripheral blood mononuclear cells (PBMCs)
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Intracellular SHIP1 protein expression in PBMCs will be measured and reported in arbitrary units.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in gp130 (CD130) protein expression in PBMCs
Tidsramme: 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.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in STAT3 protein expression in PBMCs
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Intracellular STAT3 protein expression in PBMCs will be measured and reported in arbitrary units.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in phosphorylated STAT3 protein expression in PBMCs
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Intracellular phosphorylated STAT3 (p-STAT3) protein expression in PBMCs will be measured and reported in arbitrary units.
|
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
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Intracellular IL-6 receptor alpha (CD126) protein expression in PBMCs will be measured and reported in arbitrary units.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in Beta-2 adrenergic receptor (β2-AR) protein expression in PBMCs
Tidsramme: 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.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in SOCS3 protein expression in PBMCs
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Intracellular SOCS3 protein expression in PBMCs will be measured and reported in arbitrary units.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in white blood cell count
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Total white blood cell count will be measured and reported in cells/μL.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in lymphocyte count
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Lymphocyte count will be measured and reported in cells/μL.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in neutrophil count
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Neutrophil count will be measured and reported in cells/μL.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Changes in monocyte count
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Monocyte count will be measured and reported in cells/μL.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Body fat percentage
Tidsramme: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Body fat percentage will be measured using a body composition analyzer and reported as a percentage.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
|
Lean body mass
Tidsramme: 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.
|
Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Shun-Hsi Tsai, Ph.D., National Taipei University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. april 2026
Primær fullføring (Antatt)
1. mars 2029
Studiet fullført (Antatt)
1. desember 2029
Datoer for studieregistrering
Først innsendt
15. april 2026
Først innsendt som oppfylte QC-kriteriene
28. april 2026
Først lagt ut (Faktiske)
5. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mai 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Motorisk aktivitet
- Bevegelse
- Muskel- og skjelettfysiologiske fenomener
- Muskel- og skjelett og nevrale fysiologiske fenomener
- Terapeutikk
- Fysioterapi -modaliteter
- Pasientbehandling
- Treningsterapi
- Rehabilitering
- Ettervern
- Kontinuitet i pasientbehandling
- Fysisk kondisjonering, menneskelig
- Øvelse
- Motstandstrening
Andre studie-ID-numre
- ECKIRB1140803
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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