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Completed

NCT Number: NCT01713790

Innovative Training Methods for Frail Elderly in the Training Gain Stage

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.

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Key information

Conditions

Poor Performance Status

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Slavko Rogan

Bern, Canton of Bern, 3008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stochastic resonance whole-body vibration

Device

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

Other names: SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland)

Exergame

Device

training program over 10 weeks, three times a week.

Other names: Virtual game board

Leg press

Device

training program over 10 weeks, three times a week.

Other names: Swiss Frei AG, Switzerland

Primary outcomes

  1. Short Physical Performance Battery (SPBB)

    Time frame: Change from baseline in SPBB at 10 weeks.

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

Secondary outcomes

  1. dynamic body balance

    Time frame: Change from baseline in dynamic body balance at 10 weeks.

    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.

  2. walking in single (ST) and dual task (DT) conditions

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

    • 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.

  3. mobility

    Time frame: Change from baseline in mobility at 10 weeks.

    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.

  4. knee extension maximum voluntary contraction (MVC)

    Time frame: Change from baseline in knee extension MVC at 10 weeks.

    It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.

  5. knee extension rate of force develompent (RFD)

    Time frame: Change from baseline in knee extension RFD at 10 weeks.

    It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.

  6. knee flexion maximum voluntary contraction (MVC)

    Time frame: Change from baseline in knee flexion MVC at 10 weeks.

    It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.

  7. knee flexion rate of force develompent (RFD)

    Time frame: Change from baseline in knee flexion RFD at 10 weeks.

    It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.

Sponsors and collaborators

Lead sponsor

Bern University of Applied Sciences

Other

Collaborators

  • Goethe University
  • Maastricht University Medical Center
  • Swiss Federal Institute of Technology

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 25, 2012
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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