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Innovative Training Program for Elderly in Need of Care Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02102919
Recruitment Status : Completed
First Posted : April 3, 2014
Last Update Posted : July 15, 2016
Sponsor:
Collaborators:
Goethe University
Maastricht University Medical Center
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
Heiner Baur (PhD), Bern University of Applied Sciences

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.

Condition or disease Intervention/treatment Phase
Poor Performance Status Muscle Weakness Device: SR-WBV Device: Virtual Games (VG) Other: SR-WBV Device: Aktiv Tramp (Swiss Frei AG, Switzerland) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Skilling-up Exercise for Elderly in Need of Care
Study Start Date : January 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: Intervention group
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
Device: SR-WBV
Participants will undergo a training program set over eight weeks, three times a week with 3 to 6 Hz, Noise 4.
Other Name: SRT Zeptor® med

Device: Virtual Games (VG)
Participants will undergo a training program set from week 5 to 8, three times a week over 20 minutes.
Other Name: Virtual game board

Sham Comparator: Sham Comparator
T0 - intervention 4 weeks (SR-WBV 1 Hz, noise 1) - T1 - intervention 4 weeks (SR-WBV 1 Hz, noise 1 & Aktiv Tramp) - T2
Other: SR-WBV
Participants will undergo a training program set over eight weeks three times a week with 1 Hz, Noise 1.
Other Name: SRT Zeptor® med

Device: Aktiv Tramp (Swiss Frei AG, Switzerland)
Participants will undergo a training program set from the 5 to 8 week, three times a week with 1Hz.
Other Name: Mechanically controlled trampoline.




Primary Outcome Measures :
  1. Physical performance [ Time Frame: after 8 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.


Secondary Outcome Measures :
  1. Isometric maximum voluntary contraction (IMVC) [ Time Frame: after 8 weeks ]
    It will be evaluated by isometric MCV at 90 degree angle in the knee joint.

  2. Submaximal maximum voluntary contraction (subIMVC) [ Time Frame: after 8 weeks ]
    It will be evaluated by isometric RFD at 90 degree angle in the knee joint.

  3. Isometric rate of force development (IRFD) [ Time Frame: after 8 weeks ]
    It will be evaluated by isometric RFD 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): NCT02102919


Locations
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Switzerland
Slavko Rogan
Bern, Switzerland, 3008
Sponsors and Collaborators
Bern University of Applied Sciences
Goethe University
Maastricht University Medical Center
Swiss Federal Institute of Technology
Investigators
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Principal Investigator: Heiner Baur, PhD BUAS
Study Director: Lorenz Radlinger, PhD Bern University of Applied Science, Department WGS
Study Director: Eling Douwe de Bruin, PhD Swiss Federal Institute of Technology
Study Director: Rob de Bie, Prof. Maastricht University Medical Center
Study Director: Dietmar Schmidtbleicher, Prof Goethe University
Publications of Results:
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Responsible Party: Heiner Baur (PhD), PhD, Bern University of Applied Sciences
ClinicalTrials.gov Identifier: NCT02102919    
Other Study ID Numbers: Main study (PhD)- part I
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes