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NCT Number: NCT01704976

SR-WBV Training for Frail Elderly in the Skilling up Stage

This randomized controlled study aims to examine long term effects in the skilling up phase over 4 weeks on physical functional performance and strength of mechanical SR-WBV and dance therapy intervention in a frail elderly population.

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Key information

Conditions

Poor Performance Status Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Slavko Rogan

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, measurement parameters for functional performance and strength will be used.

Goals of the study in the skilling up phase:

  • Feasibility
  • Study the effect on physical functional performance
  • Study the effects on muscle strength.

The participants will be recruited in Canton Bern - Swizerland and will be randomly allocated to an intervention group or sham group.

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 lower limb
  • acute inflammation or infection tumors
  • fresh surgical wounds
  • severe migraine
  • epilepsy
  • acute severe pain

Treatment and study plan

SR-WBV

Device

Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.

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

Primary outcomes

  1. Physical Functional Performance

    Time frame: after 4 weeks

    Short physical performance battery (SPBB): The SPBB examines 3 areas of lower extremity function: standing balance (semi-tandem stand, side-by-side stand, full tandem stand), usual walking speed and ability to stand from a chair. These areas represent essential tasks important for independent living.

    The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is "Poor performance"; SPPB 7-9 is "Intermediate performance; SPPB 10-12 is "High Performance".

Secondary outcomes

  1. Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor

    Time frame: after 4 weeks

    It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.

  2. Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension

    Time frame: after 4 weeks

    It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.

  3. Isometric Rate of Force Development (IRFD) Right Knee-extensor

    Time frame: after 4 weeks

    It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.

  4. Isometric Rate of Force Development (IRFD) Left Knee-extensor

    Time frame: after 4 weeks

    It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.

Sponsors and collaborators

Lead sponsor

Bern University of Applied Sciences

Other

Registry information

Official study title

Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 12, 2012
Registry last updated
Feb 12, 2019

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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