- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05097885
Gesundheitliche Vorteile von Ganzkörpervibrationen (VIBE-Rx)
Pilotuntersuchung zu den gesundheitlichen Vorteilen des subakuten (12-wöchigen) Ganzkörper-Vibrationstrainings
The overall goals of this pilot investigation are to determine 1) the feasibility of conducting home based WBV studies, and 2) to determine if sub-acute home based WBV can improve a) exercise capacity, b) conduit- and micro- vascular function, and c) skeletal muscle function.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Cardiovascular disease (CVD) is the leading cause of death in the world and many comorbid conditions (i.e. diabetes, obesity) can affect overall CVD risk. There is increasing interest into the role that skeletal muscle health plays in mediating CVD risk, particularly in metabolic disease states (ie. obesity and diabetes). Whole body vibration (WBV) has emerged as an exercise mimetic that may be more tolerable than traditional modes of exercise, such as treadmill walking/running or cycling. Similar to traditional exercise modalities, WBV can elicit beneficial metabolic effects. In fact, a single bout of WBV increases circulating concentrations of IL-6, which correspond with the normalization of glucose and insulin in obese individuals. The proposed pilot investigation will provide the foundation to begin understanding the molecular and physiological mechanisms of how sub-acute WBV can improve overall CVD risk. We hypothesize that home based WBV will decrease CVD risk by improving skeletal muscle and vascular function via a decrease in systemic inflammation.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Georgia
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Augusta, Georgia, Vereinigte Staaten, 30912
- Augusta University/Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Men and women (> 18 yrs old)
- All races
Exclusion Criteria:
- <18 years old
- Clinical diagnosis of hepatic, cardiovascular, or renal disease
- Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
- Pregnancy
- Direct vasoactive medications (i.e. nitrates)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Subakutes (12 Wochen) Ganzkörpertraining
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Participants will be given a personal vibration plate to take home with them for training which will last for 12 weeks. For the first four weeks, participants will be asked to complete 10 minutes of WBV per day (1 minute on and up to 1 minute of rest), at least 3-4 days per week. At least 24 hours will be recommended in between sessions during weeks 1-4. Beginning at week 5, participants will be asked to increase WBV time to up to 14 minutes and/or reduce the duration of rest. Beginning at week 9, participants will be asked to increase WBV time to up to 20 minutes and/or reduce the duration of rest. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in VO2 Peak
Zeitfenster: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
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change from baseline relative (mL/kg/min) peak oxygen consumption (VO2) during maximal exercise test at 12 weeks |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
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Change in Flow-Mediated Dilation (FMD)
Zeitfenster: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
change from baseline brachial artery flow mediated dilation at 12 weeks. |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
|
Change in Skeletal Muscle Mitochondrial Function
Zeitfenster: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
change from baseline skeletal muscle mitochondrial function at 12 weeks. Measured using Near Infrared Spectroscopy (NIRS). Values are an index of phosphocreatine recovery expressed as a rate constant (min-1) |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
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Change in Pulse Wave Velocity (PWV)
Zeitfenster: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
Change from baseline PWV at 12 weeks. Measured by Shygmocor Xcel in m/s. |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
|
Change in Post Occlusive Reactive Hyperemia (PORH)
Zeitfenster: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
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Change from baseline PORH at 12 weeks. Measured by Laser Speckle Contrast Imager (Moor FLPI). |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
|
Change in IL-6
Zeitfenster: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
change from baseline concentrations of Interleukin 6 (IL-6) obtained via blood draw at 12 weeks. |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 1818010
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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