Innovative Training Methods for Frail Elderly in the Training Gain Stage

NCT ID: NCT01713790

Last Updated: 2015-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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, adapted measurement parameters for balance, strength and cognition will be used.

The goals of this study:

Evaluate the effects of

* functional lower extremity
* dynamic balance
* reaction time
* mobility
* muscle strength and cognition.

This is a one-group pre-post design study and the participants will be recruited in Canton Bern - Switzerland.

Conditions

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Poor Performance Status

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Training group

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

Group Type EXPERIMENTAL

Stochastic resonance whole-body vibration

Intervention Type DEVICE

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

Exergame

Intervention Type DEVICE

training program over 10 weeks, three times a week.

Leg press

Intervention Type DEVICE

training program over 10 weeks, three times a week.

Interventions

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Stochastic resonance whole-body vibration

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

Intervention Type DEVICE

Exergame

training program over 10 weeks, three times a week.

Intervention Type DEVICE

Leg press

training program over 10 weeks, three times a week.

Intervention Type DEVICE

Other Intervention Names

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SRT ZeptorĀ® med plus Noise (Swiss Frei AG, Switzerland) Virtual game board Swiss Frei AG, Switzerland

Eligibility Criteria

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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 inflammation or infection tumors
* fresh surgical wounds
* severe migraine
* epilepsy
* acute severe pain
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Goethe University

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role collaborator

Bern University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Heiner Baur (PhD)

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Slavko Rogan, MSc

Role: STUDY_CHAIR

Bern University of Applied Science, Department WGS

Lorenz Radlinger, PhD

Role: STUDY_DIRECTOR

Bern University of Applied Science, Department WGS

Dietmar Schmidtbleicher, Prof., PhD

Role: STUDY_DIRECTOR

Johann Wolfgang Goethe University, Department Sport Science

Rob de Bie, Prof., PhD

Role: STUDY_DIRECTOR

University Maastricht, Department Epidemiology

Eling D de Bruin, Prof., PhD

Role: STUDY_DIRECTOR

Swiss Federal Institute of Technology Zurich, Department Human Movement Science

Baur Heiner, PhD

Role: PRINCIPAL_INVESTIGATOR

Bern University of Applied Sciences

Locations

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Slavko Rogan

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Main study (PhD)- part II

Identifier Type: -

Identifier Source: org_study_id

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