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SR-WBV Training for Frail Elderly in the Skilling up Stage

28. januar 2019 opdateret af: Slavko Rogan, Bern University of Applied Sciences

Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance

This randomized controlled study aims to examine long term effects in the skilling up phase over 4 weeks on physical functional performance and strength of mechanical SR-WBV and dance therapy intervention in a frail elderly population.

Studieoversigt

Status

Afsluttet

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:

  1. Feasibility
  2. Study the effect on physical functional performance
  3. 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

Interventionel

Tilmelding (Faktiske)

27

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Bern, Schweiz, 3008
        • Slavko Rogan

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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:
  • SRT Zeptor® med plus Noise (Swiss Frei AG, Schweiz)
  • Intervention-Group
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Andre navne:
  • SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland
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:
  • SRT Zeptor® med plus Noise (Swiss Frei AG, Schweiz)
  • Intervention-Group
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Andre navne:
  • SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland

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
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2012

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

7. oktober 2012

Først indsendt, der opfyldte QC-kriterier

10. oktober 2012

Først opslået (Skøn)

12. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

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

Abonner