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

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ClinicalTrials.gov Identifier: NCT01704976
Recruitment Status : Completed
First Posted : October 12, 2012
Results First Posted : December 24, 2014
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Slavko Rogan, Bern University of Applied Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Poor Performance Status Muscle Weakness Device: SR-WBV Not Applicable

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

Goals of the study in the skilling up phase:

  1. Feasibility
  2. Study the effect on physical functional performance
  3. 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance
Study Start Date : September 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Arm Intervention/treatment
Experimental: Intervention
T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1
Device: SR-WBV
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

Sham Comparator: Sham group
T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (1 Hz, noise 1) - T1
Device: SR-WBV
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Other Name: SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 lower limb
  • acute inflammation or infection tumors
  • fresh surgical wounds
  • severe migraine
  • epilepsy
  • acute severe pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704976


Locations
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Switzerland
Slavko Rogan
Bern, Switzerland, 3008
Sponsors and Collaborators
Bern University of Applied Sciences
Investigators
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Study Chair: Rogan Slavko, MSc Bern University of Applied Science, Department WGS
Study Director: Radlinger Lorenz, PhD Bern University of Applied Science, Department WGS
Principal Investigator: Baur Heiner, PhD Bern University of Applied Sciences
Study Chair: Jessica Kessler, MSc BUAS

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Slavko Rogan, PTMsc, Bern University of Applied Sciences
ClinicalTrials.gov Identifier: NCT01704976     History of Changes
Other Study ID Numbers: MSc-study (Biel)
First Posted: October 12, 2012    Key Record Dates
Results First Posted: December 24, 2014
Last Update Posted: February 12, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms