NCT02332083

Brief Summary

The goal of this randomized controlled study was to examine the effects of a 8 weeks innovative training regime (stochastic resonance whole-body vibration \[SR-WBV\] and virtual virtual games \[VG\]) in the skilling up phase on physical performance, cognition and falls in elderly in need of care population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

January 4, 2015

Last Update Submit

February 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (2)

  • Cognition

    8 weeks

  • The falls efficacy scale-international (FES-I)

    8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (start with 3 up to 6 Hz, noise 4) T1 - intervention 4 weeks (SR-WBV (start with 3 up to 6Hz, noise 4 \& Exergame) - T2

Device: SR-WBVDevice: Exergame

Sham Comparator

SHAM COMPARATOR

T0 - intervention 4 weeks (SR-WBV 1 Hz, noise 1) - T1 - intervention 4 weeks (SR-WBV 1 Hz, noise 1 \& Aktiv Tramp) - T2

Other: SR-WBVDevice: Aktiv Tramp

Interventions

SR-WBVDEVICE

Participants will undergo a training program set over eight weeks, three times a week with 3 to 6 Hz, Noise 4.

Also known as: SRT Zeptor® med
Intervention group
ExergameDEVICE

Participants will undergo a training program set from week 5 to 8, three times a week over 20 minutes.

Also known as: Virtual game board
Intervention group

Participants will undergo a training program set from the 5 to 8 week, three times a week over 4 minutes.

Also known as: Trampoline
Sham Comparator

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • RAI (Resident Assessment Instrument) \>0
  • live in canton Zurich
  • in terms of training load be resistant.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bern University of Applied Science, Department Health

Bern, 3008, Switzerland

Location

Study Officials

  • Heiner Baur, PD PhD

    BUAS

    PRINCIPAL INVESTIGATOR
  • Eling de Bruin, PD PhD

    ETHZ

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 4, 2015

First Posted

January 6, 2015

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

February 11, 2019

Record last verified: 2019-02

Locations