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

Primary Purpose

Poor Performance Status, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
SR-WBV
SR-WBV
Sponsored by
Bern University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Poor Performance Status

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Slavko Rogan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention

Sham group

Arm Description

T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1

T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (1 Hz, noise 1) - T1

Outcomes

Primary Outcome Measures

Physical Functional Performance
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

Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor
It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension
It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
Isometric Rate of Force Development (IRFD) Right Knee-extensor
It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
Isometric Rate of Force Development (IRFD) Left Knee-extensor
It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.

Full Information

First Posted
October 7, 2012
Last Updated
January 28, 2019
Sponsor
Bern University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01704976
Brief Title
SR-WBV Training for Frail Elderly in the Skilling up Stage
Official Title
Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bern University of Applied Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poor Performance Status, Muscle Weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (1 Hz, noise 1) - T1
Intervention Type
Device
Intervention Name(s)
SR-WBV
Other Intervention Name(s)
SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland), Intervention-Group
Intervention Description
Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.
Intervention Type
Device
Intervention Name(s)
SR-WBV
Other Intervention Name(s)
SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland
Intervention Description
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Primary Outcome Measure Information:
Title
Physical Functional Performance
Description
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".
Time Frame
after 4 weeks
Secondary Outcome Measure Information:
Title
Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor
Description
It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
Time Frame
after 4 weeks
Title
Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension
Description
It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
Time Frame
after 4 weeks
Title
Isometric Rate of Force Development (IRFD) Right Knee-extensor
Description
It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
Time Frame
after 4 weeks
Title
Isometric Rate of Force Development (IRFD) Left Knee-extensor
Description
It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
Time Frame
after 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 lower limb acute inflammation or infection tumors fresh surgical wounds severe migraine epilepsy acute severe pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rogan Slavko, MSc
Organizational Affiliation
Bern University of Applied Science, Department WGS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Radlinger Lorenz, PhD
Organizational Affiliation
Bern University of Applied Science, Department WGS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Baur Heiner, PhD
Organizational Affiliation
Bern University of Applied Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jessica Kessler, MSc
Organizational Affiliation
BUAS
Official's Role
Study Chair
Facility Information:
Facility Name
Slavko Rogan
City
Bern
ZIP/Postal Code
3008
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25042993
Citation
Kessler J, Radlinger L, Baur H, Rogan S. Effect of stochastic resonance whole body vibration on functional performance in the frail elderly: A pilot study. Arch Gerontol Geriatr. 2014 Sep-Oct;59(2):305-11. doi: 10.1016/j.archger.2014.06.005. Epub 2014 Jul 9.
Results Reference
derived

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

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