- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Bern, Schweiz, 3008
- Slavko Rogan
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Andra namn:
|
|
Sham Comparator: 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.
Andra namn:
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Physical Functional Performance
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: after 4 weeks
|
It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
|
after 4 weeks
|
Samarbetspartners och utredare
Utredare
- Studiestol: Rogan Slavko, MSc, Bern University of Applied Science, Department WGS
- Studierektor: Radlinger Lorenz, PhD, Bern University of Applied Science, Department WGS
- Studiestol: Jessica Kessler, MSc, BUAS
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MSc-study (Biel)
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