- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01704976
SR-WBV Training for Frail Elderly in the Skilling up Stage
Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study is based on the guideline of falls management exercise programs (FaME; from Skelton and Dinan).
The goals:
Skilling up: improvement in neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.
Training Gain: improvement of functional abilities. Maintaining the Gains: muscle growth, improvement of bone density and multi-sensory exercises.
First, a pilot study was conducted with untrained elderly ("Effects of stochastic resonance therapy on postural control in the elderly population" (KEK Bern: No.228/09, Clinical Trial Registry: NCT01045746). Following, a second pilot study was conducted with frail elderly (Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control Clinical Trial Registry:NCT01543243).
It was found that the selected chosen form of recruitment (presentation and advertisement) and the measurements methods are suitable for untrained elderly. But for frail elderly the chosen form of recruitment and the measurement methods are not sufficient.
For this study, measurement parameters for functional performance and strength will be used.
Goals of the study in the skilling up phase:
- Feasibility
- Study the effect on physical functional performance
- Study the effects on muscle strength.
The participants will be recruited in Canton Bern - Swizerland and will be randomly allocated to an intervention group or sham group.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Bern, Schweiz, 3008
- Slavko Rogan
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- RAI (Resident Assessment Instrument) >0
- live in canton Bern
- in terms of training load be resistant.
Exclusion Criteria:
- acut joint disease, acut thrombosis, acute fractures, acute infections, acute tissue damage, or acute -- surgical scars
- seniors with prosthesis.
- alcoholic
- acute joint disease, activated osteoarthritis, rheumatoid arthritis, acute lower limb
- acute inflammation or infection tumors
- fresh surgical wounds
- severe migraine
- epilepsy
- acute severe pain
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Intervention
T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1
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Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.
Andere Namen:
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Andere Namen:
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Schein-Komparator: Sham group
T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (1 Hz, noise 1) - T1
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Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.
Andere Namen:
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Physical Functional Performance
Zeitfenster: after 4 weeks
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Short physical performance battery (SPBB): The SPBB examines 3 areas of lower extremity function: standing balance (semi-tandem stand, side-by-side stand, full tandem stand), usual walking speed and ability to stand from a chair. These areas represent essential tasks important for independent living. The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is "Poor performance"; SPPB 7-9 is "Intermediate performance; SPPB 10-12 is "High Performance". |
after 4 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor
Zeitfenster: after 4 weeks
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It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
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after 4 weeks
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Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension
Zeitfenster: after 4 weeks
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It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
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after 4 weeks
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Isometric Rate of Force Development (IRFD) Right Knee-extensor
Zeitfenster: after 4 weeks
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It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
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after 4 weeks
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Isometric Rate of Force Development (IRFD) Left Knee-extensor
Zeitfenster: after 4 weeks
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It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
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after 4 weeks
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Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Rogan Slavko, MSc, Bern University of Applied Science, Department WGS
- Studienleiter: Radlinger Lorenz, PhD, Bern University of Applied Science, Department WGS
- Studienstuhl: Jessica Kessler, MSc, BUAS
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MSc-study (Biel)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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