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Innovative Training Program for Elderly in Need of Care Individuals

Primary Purpose

Poor Performance Status, Muscle Weakness

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
SR-WBV
Virtual Games (VG)
SR-WBV
Aktiv Tramp (Swiss Frei AG, Switzerland)
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 group

Sham Comparator

Arm Description

T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (start with 3 up to 6 Hz, noise 4) T1 - intervention 4 weeks (SR-WBV (start with 3 up to 6Hz, noise 4 & virtual games) - T2

T0 - intervention 4 weeks (SR-WBV 1 Hz, noise 1) - T1 - intervention 4 weeks (SR-WBV 1 Hz, noise 1 & Aktiv Tramp) - T2

Outcomes

Primary Outcome Measures

Physical 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.

Secondary Outcome Measures

Isometric maximum voluntary contraction (IMVC)
It will be evaluated by isometric MCV at 90 degree angle in the knee joint.
Submaximal maximum voluntary contraction (subIMVC)
It will be evaluated by isometric RFD at 90 degree angle in the knee joint.
Isometric rate of force development (IRFD)
It will be evaluated by isometric RFD at 90 degree angle in the knee joint.

Full Information

First Posted
March 31, 2014
Last Updated
July 14, 2016
Sponsor
Bern University of Applied Sciences
Collaborators
Goethe University, Maastricht University Medical Center, Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02102919
Brief Title
Innovative Training Program for Elderly in Need of Care Individuals
Official Title
Skilling-up Exercise for Elderly in Need of Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bern University of Applied Sciences
Collaborators
Goethe University, Maastricht University Medical Center, Swiss Federal Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomized controlled study was to examine the effects of a 8 weeks innovative training regime (stochastic resonance whole-body vibration [SR-WBV] and virtual virtual games [VG]) in the skilling up phase on physical performance and strength in elderly in need of care population.
Detailed Description
Sensorimotor and strength exercise are methods to increase strength & power in the field of geriatrics. The question that arise what exercises are best suited to and most effective for elderly in need of care individuals. Such populations are advised first to enter a "skilling up program" before more traditional forms of training exercises are implemented. Goals in the skilling up phase: improvement in neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity. The aim of the study in the skilling up phase: Study the effect on physical performance Study the effects on muscle strength.. The participants will be recruited in Canton Bern - Switzerland 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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (start with 3 up to 6 Hz, noise 4) T1 - intervention 4 weeks (SR-WBV (start with 3 up to 6Hz, noise 4 & virtual games) - T2
Arm Title
Sham Comparator
Arm Type
Sham Comparator
Arm Description
T0 - intervention 4 weeks (SR-WBV 1 Hz, noise 1) - T1 - intervention 4 weeks (SR-WBV 1 Hz, noise 1 & Aktiv Tramp) - T2
Intervention Type
Device
Intervention Name(s)
SR-WBV
Other Intervention Name(s)
SRT Zeptor® med
Intervention Description
Participants will undergo a training program set over eight weeks, three times a week with 3 to 6 Hz, Noise 4.
Intervention Type
Device
Intervention Name(s)
Virtual Games (VG)
Other Intervention Name(s)
Virtual game board
Intervention Description
Participants will undergo a training program set from week 5 to 8, three times a week over 20 minutes.
Intervention Type
Other
Intervention Name(s)
SR-WBV
Other Intervention Name(s)
SRT Zeptor® med
Intervention Description
Participants will undergo a training program set over eight weeks three times a week with 1 Hz, Noise 1.
Intervention Type
Device
Intervention Name(s)
Aktiv Tramp (Swiss Frei AG, Switzerland)
Other Intervention Name(s)
Mechanically controlled trampoline.
Intervention Description
Participants will undergo a training program set from the 5 to 8 week, three times a week with 1Hz.
Primary Outcome Measure Information:
Title
Physical 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.
Time Frame
after 8 weeks
Secondary Outcome Measure Information:
Title
Isometric maximum voluntary contraction (IMVC)
Description
It will be evaluated by isometric MCV at 90 degree angle in the knee joint.
Time Frame
after 8 weeks
Title
Submaximal maximum voluntary contraction (subIMVC)
Description
It will be evaluated by isometric RFD at 90 degree angle in the knee joint.
Time Frame
after 8 weeks
Title
Isometric rate of force development (IRFD)
Description
It will be evaluated by isometric RFD at 90 degree angle in the knee joint.
Time Frame
after 8 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
Heiner Baur, PhD
Organizational Affiliation
BUAS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lorenz Radlinger, PhD
Organizational Affiliation
Bern University of Applied Science, Department WGS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eling Douwe de Bruin, PhD
Organizational Affiliation
Swiss Federal Institute of Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rob de Bie, Prof.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dietmar Schmidtbleicher, Prof
Organizational Affiliation
Goethe University
Official's Role
Study Director
Facility Information:
Facility Name
Slavko Rogan
City
Bern
ZIP/Postal Code
3008
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27239241
Citation
Rogan S, Radlinger L, Baur H, Schmidtbleicher D, de Bie RA, de Bruin ED. Sensory-motor training targeting motor dysfunction and muscle weakness in long-term care elderly combined with motivational strategies: a single blind randomized controlled study. Eur Rev Aging Phys Act. 2016 May 28;13:4. doi: 10.1186/s11556-016-0164-0. eCollection 2016.
Results Reference
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Innovative Training Program for Elderly in Need of Care Individuals

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