- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02102919
Innovative Training Program for Elderly in Need of Care Individuals
Skilling-up Exercise for Elderly in Need of Care
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Bern, Switzerland, 3008
- Slavko Rogan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
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Participants will undergo a training program set over eight weeks, three times a week with 3 to 6 Hz, Noise 4.
Other Names:
Participants will undergo a training program set from week 5 to 8, three times a week over 20 minutes.
Other Names:
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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
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Participants will undergo a training program set over eight weeks three times a week with 1 Hz, Noise 1.
Other Names:
Participants will undergo a training program set from the 5 to 8 week, three times a week with 1Hz.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical performance
Time Frame: after 8 weeks
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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.
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after 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Isometric maximum voluntary contraction (IMVC)
Time Frame: after 8 weeks
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It will be evaluated by isometric MCV at 90 degree angle in the knee joint.
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after 8 weeks
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Submaximal maximum voluntary contraction (subIMVC)
Time Frame: after 8 weeks
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It will be evaluated by isometric RFD at 90 degree angle in the knee joint.
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after 8 weeks
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Isometric rate of force development (IRFD)
Time Frame: after 8 weeks
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It will be evaluated by isometric RFD at 90 degree angle in the knee joint.
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after 8 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Heiner Baur, PhD, BUAS
- 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 and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Main study (PhD)- part I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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