- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Bern, Sveits, 3008
- Slavko Rogan
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention
T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1
|
Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.
Andre navn:
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Andre navn:
|
|
Sham-komparator: Sham group
T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (1 Hz, noise 1) - T1
|
Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.
Andre navn:
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical Functional Performance
Tidsramme: after 4 weeks
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor
Tidsramme: after 4 weeks
|
It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
|
after 4 weeks
|
|
Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension
Tidsramme: after 4 weeks
|
It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
|
after 4 weeks
|
|
Isometric Rate of Force Development (IRFD) Right Knee-extensor
Tidsramme: after 4 weeks
|
It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
|
after 4 weeks
|
|
Isometric Rate of Force Development (IRFD) Left Knee-extensor
Tidsramme: after 4 weeks
|
It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
|
after 4 weeks
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Rogan Slavko, MSc, Bern University of Applied Science, Department WGS
- Studieleder: Radlinger Lorenz, PhD, Bern University of Applied Science, Department WGS
- Studiestol: Jessica Kessler, MSc, BUAS
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MSc-study (Biel)
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