NCT01713790

Brief Summary

This study aims to examine long term effects in the training gain stage of the falls management exercise programs (FaME, from Skelton and Dinan) over 10 weeks on physical functional performance after mechanical SR-WBV, dance therapy and strength training intervention in a frail elderly population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

2.5 years

First QC Date

October 14, 2012

Last Update Submit

July 22, 2015

Conditions

Keywords

physical functional performancepostural balancereaction timemobilitymuscle strengthcognition

Outcome Measures

Primary Outcomes (1)

  • Short Physical Performance Battery (SPBB)

    The SPBB assess lower extremity function at baseline and after a 10-week interventions period.

    Change from baseline in SPBB at 10 weeks.

Secondary Outcomes (7)

  • dynamic body balance

    Change from baseline in dynamic body balance at 10 weeks.

  • walking in single (ST) and dual task (DT) conditions

    Change from baseline during walking in ST and DT condition at 10 weeks.

  • mobility

    Change from baseline in mobility at 10 weeks.

  • knee extension maximum voluntary contraction (MVC)

    Change from baseline in knee extension MVC at 10 weeks.

  • knee extension rate of force develompent (RFD)

    Change from baseline in knee extension RFD at 10 weeks.

  • +2 more secondary outcomes

Study Arms (1)

Training group

EXPERIMENTAL

T0 - Intervention program 3x/ week over 10 weeks: Stochastic resonance whole-body vibration + Exergame + leg press - T1

Device: Stochastic resonance whole-body vibrationDevice: ExergameDevice: Leg press

Interventions

Stochastic resonance whole-body vibration training program over 10 weeks, three times a week with 3 to 6 Hz, Noise 4.

Also known as: SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland)
Training group
ExergameDEVICE

training program over 10 weeks, three times a week.

Also known as: Virtual game board
Training group
Leg pressDEVICE

training program over 10 weeks, three times a week.

Also known as: Swiss Frei AG, Switzerland
Training group

Eligibility Criteria

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

You may qualify if:

  • RAI (Resident Assessment Instrument) \>0
  • live in canton Bern
  • 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 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)

Slavko Rogan

Bern, Canton of Bern, 3008, Switzerland

Location

Study Officials

  • Slavko Rogan, MSc

    Bern University of Applied Science, Department WGS

    STUDY CHAIR
  • Lorenz Radlinger, PhD

    Bern University of Applied Science, Department WGS

    STUDY DIRECTOR
  • Dietmar Schmidtbleicher, Prof., PhD

    Johann Wolfgang Goethe University, Department Sport Science

    STUDY DIRECTOR
  • Rob de Bie, Prof., PhD

    University Maastricht, Department Epidemiology

    STUDY DIRECTOR
  • Eling D de Bruin, Prof., PhD

    Swiss Federal Institute of Technology Zurich, Department Human Movement Science

    STUDY DIRECTOR
  • Baur Heiner, PhD

    Bern University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 14, 2012

First Posted

October 25, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations