Clinical trial NCT01713790: Innovative Training Methods for Frail Elderly in the Training Gain Stage
Official title: Effects of Whole Body Vibration With Stochastic Resonance and Exergames in the Elderly in Need of Care: Effects on Physical Functional Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Performance Status
Keywords: physical functional performance
postural balance
reaction time
mobility
muscle strength
cognition
Lead sponsor: Bern University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Goethe University
name: Maastricht University Medical Center
name: Swiss Federal Institute of Technology
First posted: 2012-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Short Physical Performance Battery (SPBB)
timeFrame: Change from baseline in SPBB at 10 weeks.
Secondary outcomes:
measure: dynamic body balance
timeFrame: Change from baseline in dynamic body balance at 10 weeks.
measure: walking in single (ST) and dual task (DT) conditions
timeFrame: Change from baseline during walking in ST and DT condition at 10 weeks.
measure: mobility
timeFrame: Change from baseline in mobility at 10 weeks.
measure: knee extension maximum voluntary contraction (MVC)
timeFrame: Change from baseline in knee extension MVC at 10 weeks.
measure: knee extension rate of force develompent (RFD)
timeFrame: Change from baseline in knee extension RFD at 10 weeks.
measure: knee flexion maximum voluntary contraction (MVC)
timeFrame: Change from baseline in knee flexion MVC at 10 weeks.
measure: knee flexion rate of force develompent (RFD)
timeFrame: Change from baseline in knee flexion RFD at 10 weeks.
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Slavko Rogan
Study officials:
affiliation: Bern University of Applied Science, Department WGS
name: Slavko Rogan, MSc
role: STUDY_CHAIR
affiliation: Bern University of Applied Science, Department WGS
name: Lorenz Radlinger, PhD
role: STUDY_DIRECTOR
affiliation: Johann Wolfgang Goethe University, Department Sport Science
name: Dietmar Schmidtbleicher, Prof., PhD
role: STUDY_DIRECTOR
affiliation: University Maastricht, Department Epidemiology
name: Rob de Bie, Prof., PhD
role: STUDY_DIRECTOR
affiliation: Swiss Federal Institute of Technology Zurich, Department Human Movement Science
name: Eling D de Bruin, Prof., PhD
role: STUDY_DIRECTOR
affiliation: Bern University of Applied Sciences
name: Baur Heiner, PhD
role: PRINCIPAL_INVESTIGATOR
References: