Clinical trial NCT00783159: Fit in the Aged by Professional Training
Official title: The Effect of Different Training Modalities and Vitamin D Supplementation on Functionality in Prefrail Elderly Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Sarcopenia
Keywords: Muscle power
Frailty
Exercise
Vitamin D
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Klinikum Nürnberg
name: Institute of Biomedicine of Aging
name: University of Erlangen-Nürnberg
name: Institute of Sport Science and Sport
name: Robert Bosch Medical Center
First posted: 2008-10-31
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Short physical performance battery
timeFrame: 3 months after intervention
Secondary outcomes:
measure: Muscle strength and muscle power
timeFrame: 3 months after intervention
Other outcomes:
Locations:
city: Nuremberg
country: Germany
facility: Institute of Biomedicine of Aging
Study officials:
affiliation: University of Erlangen-Nürnberg
name: Cornel C. Sieber, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Erlangen-Nürnberg
name: Klaus Pfeifer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schaupp A, Bidlingmaier M, Martini S, Reincke M, Schluessel S, Schmidmaier R, Drey M. Resistance training-induced improvement in physical function is not associated to changes in endocrine somatotropic activity in prefrail older adults. Arch Gerontol Geriatr. 2022 Nov-Dec;103:104792. doi: 10.1016/j.archger.2022.104792. Epub 2022 Aug 14.
citation: Zech A, Drey M, Freiberger E, Hentschke C, Bauer JM, Sieber CC, Pfeifer K. Residual effects of muscle strength and muscle power training and detraining on physical function in community-dwelling prefrail older adults: a randomized controlled trial. BMC Geriatr. 2012 Nov 7;12:68. doi: 10.1186/1471-2318-12-68.
citation: Drey M, Zech A, Freiberger E, Bertsch T, Uter W, Sieber CC, Pfeifer K, Bauer JM. Effects of strength training versus power training on physical performance in prefrail community-dwelling older adults. Gerontology. 2012;58(3):197-204. doi: 10.1159/000332207. Epub 2011 Nov 3.