- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Bern, Schweiz, 3008
- Slavko Rogan
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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 navne:
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Andre navne:
|
|
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 navne:
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
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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
|
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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
|
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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
|
Samarbejdspartnere og efterforskere
Efterforskere
- 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
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MSc-study (Biel)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med SR-WBV
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Bern University of Applied SciencesSwiss Federal Institute of TechnologyAfsluttetDårlig præstationsstatus | Kognition - AndetSchweiz
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Istanbul Physical Medicine Rehabilitation Training...AfsluttetVægtbærende | Positur | H-reflex | Spinale reflekser | Neuromuskulær fysiologiTyrkiet (Türkiye)
-
Universidade Federal do Rio Grande do NorteAfsluttetUmiddelbare virkninger af helkropsvibrationer på neuromuskulær ydeevne og postural kontrol hos ældreNeuromuskulær ydeevne og balanceBrasilien
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Universidade Federal do Rio Grande do NorteAfsluttetNeuromuskulær ydeevne og balanceBrasilien
-
Universidade Federal de PernambucoAfsluttetSkrøbelige ældres syndromBrasilien
-
Universidade Federal de PernambucoAfsluttet
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Bern University of Applied SciencesGoethe University; Maastricht University Medical Center; Swiss Federal Institute...AfsluttetMuskelsvaghed | Dårlig præstationsstatusSchweiz
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Istanbul Physical Medicine Rehabilitation Training...AfsluttetMuskelspasticitet | FysiologiKalkun
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Bagcilar Training and Research HospitalAfsluttetVirkninger af vibrationer | KnoglemasseKalkun