Innovative Training Methods for Frail Elderly in the Training Gain Stage

Poor Performance Status Clinical Trial

Official title:

Effects of Whole Body Vibration With Stochastic Resonance and Exergames in the Elderly in Need of Care: Effects on Physical Functional Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713790
• Other study ID #: Main study (PhD)- part II
• Status: Completed
• Phase: N/A
• First received: October 14, 2012
• Last updated: July 22, 2015
• Start date: October 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Bern University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Poor Performance Status

Intervention

Device:
• 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.
• Exergame
training program over 10 weeks, three times a week.
• Leg press
training program over 10 weeks, three times a week.

Locations

Country	Name	City	State
Switzerland	Slavko Rogan	Bern

Sponsors (4)

Lead Sponsor	Collaborator
Bern University of Applied Sciences	Goethe University, Maastricht University Medical Center, Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	dynamic body balance	The Expanded Timed Get Up-and-Go (ETGUG) will be used for measuring dynamic body balance. At 2, 8 and 10 meters along the walkway, markers were set. In the ETGUG test, times for the component tasks are measured at baseline and after a 10-week interventions period.	Change from baseline in dynamic body balance at 10 weeks.	No
Secondary	walking in single (ST) and dual task (DT) conditions	For the single task condition, the participants will be instructed to walk a distance of 20 meters at their self-selected walking speed. Total time were measured.; For the dual task condition, the participant had to count backwards from the number 250 in steps of 7 while walking the same distance at their self-selected walking speed. Total walking times were measured.; The time differences between the two tasks are evaluated at baseline and after a 10-week interventions period.	Change from baseline during walking in ST and DT condition at 10 weeks.	No
Secondary	mobility	The participants using a StepWatch ™ Activity Monitor (SAM) pedometer. This digital pedometer record the total daily steps at baseline and after a 10-week interventions period.	Change from baseline in mobility at 10 weeks.	No
Secondary	knee extension maximum voluntary contraction (MVC)	It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.	Change from baseline in knee extension MVC at 10 weeks.	No
Secondary	knee extension rate of force develompent (RFD)	It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.	Change from baseline in knee extension RFD at 10 weeks.	No
Secondary	knee flexion maximum voluntary contraction (MVC)	It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.	Change from baseline in knee flexion MVC at 10 weeks.	No
Secondary	knee flexion rate of force develompent (RFD)	It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.	Change from baseline in knee flexion RFD at 10 weeks.	No