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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00783159
Other study ID # 32.5.8051.0113.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2008
Est. completion date May 2010

Study information

Verified date December 2020
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This intervention study tests training methods to stabilize or improve functionality in the high risk group of prefrail elderly persons.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date May 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Prefrailty according to the frailty score of Fried Exclusion Criteria: - Sarcoidosis - Nephrolithiasis - Plasmacytoma - COPD - Inflammatory bowel disease - Rheumatoid arthritis - History of cancer - Instable heart disease - Depression (GDS>=6) - Dementia (MMSE<=24) - BMI>35kg/m² - Current attendance of muscle training - Medication: immunosuppressive drugs

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Power Training
Power training, Vitamin D substitution
Strength Training
Strength training, Vitamin D substitution
Other:
Control
Vitamin D substitution, Lifestyle consultation

Locations

Country Name City State
Germany Institute of Biomedicine of Aging Nuremberg

Sponsors (6)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School Institute of Biomedicine of Aging, Institute of Sport Science and Sport, Klinikum Nürnberg, Robert Bosch Medical Center, University of Erlangen-Nürnberg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Short physical performance battery 3 months after intervention
Secondary Muscle strength and muscle power 3 months after intervention
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