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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02102919
Other study ID # Main study (PhD)- part I
Secondary ID
Status Completed
Phase Phase 4
First received March 31, 2014
Last updated July 14, 2016
Start date January 2013
Est. completion date February 2015

Study information

Verified date July 2016
Source Bern University of Applied Sciences
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
SR-WBV
Participants will undergo a training program set over eight weeks, three times a week with 3 to 6 Hz, Noise 4.
Virtual Games (VG)
Participants will undergo a training program set from week 5 to 8, three times a week over 20 minutes.
Other:
SR-WBV
Participants will undergo a training program set over eight weeks three times a week with 1 Hz, Noise 1.
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.

Locations

Country Name City State
Switzerland Slavko Rogan Bern

Sponsors (4)

Lead Sponsor Collaborator
Bern University of Applied Sciences Goethe University, Maastricht University Medical Center, Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. Eu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. after 8 weeks Yes
Secondary Isometric maximum voluntary contraction (IMVC) It will be evaluated by isometric MCV at 90 degree angle in the knee joint. after 8 weeks Yes
Secondary Submaximal maximum voluntary contraction (subIMVC) It will be evaluated by isometric RFD at 90 degree angle in the knee joint. after 8 weeks Yes
Secondary Isometric rate of force development (IRFD) It will be evaluated by isometric RFD at 90 degree angle in the knee joint. after 8 weeks Yes
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