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| Sponsors and Collaborators: |
University of Erlangen-Nürnberg Klinikum Nuremberg Institute of Biomedicine of Aging University of Erlangen-Nuremberg Institute of Sport Science and Sport Robert Bosch Foundation |
|---|---|
| Information provided by: | University of Erlangen-Nürnberg |
| ClinicalTrials.gov Identifier: | NCT00783159 |
Purpose
This intervention study tests training methods to stabilize or improve functionality in the high risk group of prefrail elderly persons.
| Condition | Intervention |
|---|---|
|
Frailty Sarcopenia |
Other: Training I Other: Training II Other: Control |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment |
| Official Title: | The Effect of Different Training Modalities and Vitamin D Supplementation on Functionality in Prefrail Elderly Persons |
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Training I
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Other: Training I
Power training, Vitamin D substitution
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B: Experimental
Training II
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Other: Training II
Strength training, Vitamin D substitution
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C: Active Comparator
Control
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Other: Control
Vitamin D substitution, Lifestyle consultation
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This study aims at the improvement of muscular function by physical exercise in prefrail elderly persons. Prefrail participants are recruited according to the frailty score of Fried. Taking into account, that vitamin D supplementation reduces falls and improves muscle strength in older people, all participants are supplemented by vitamin D. Two different training methods are tested.
After a run-in period of supplementation of vitamin D for two months, participants will be randomized into three different equally sized groups (n=25): Group A will receive power training. Group B will have progressive strength training. Group C will serve as a control group. They will receive a consultation about leading a healthy life with special attention being paid to nutrition and physical activity. The intervention period lasts for 12 weeks. The 60 minutes training sessions will be held two times a week by members of the Institute of Sport Science and Sports of the University of Erlangen-Nuremberg. Follow-up visits are scheduled three and six months after intervention period.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michael Drey, MD | 0049-911-3000512 | michael.drey@gmx.de |
| Germany | |
| Institute of Biomedicine of Aging | Recruiting |
| Nuremberg, Germany, 90419 | |
| Contact: Michael Drey, MD 0049-911-3000512 michael.drey@gmx.de | |
| Contact: Juergen Bauer, MD 0049-911-3982748 juergen.bauer@klinikum-nuernberg.de | |
| Principal Investigator: Michael Drey, MD | |
| Principal Investigator: | Cornel C. Sieber, Prof. Dr. | University of Erlangen-Nuremberg |
| Principal Investigator: | Klaus Pfeifer, Prof. Dr. | University of Erlangen-Nuremberg |
More Information
| Responsible Party: | Institute of Biomedicine of Aging ( Prof. Dr. Cornel Sieber ) |
| Study ID Numbers: | 32.5.8051.0113.0 |
| Study First Received: | October 30, 2008 |
| Last Updated: | October 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00783159 |
| Health Authority: | Germany: Ethics Commission |
|
Muscle power Frailty Exercise Vitamin D |
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Vitamin D Ergocalciferols |
|
Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |
