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Fit in the Aged by Professional Training (FiAT)

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ClinicalTrials.gov Identifier: NCT00783159
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : January 12, 2011
Sponsor:
Collaborators:
Klinikum Nürnberg
Institute of Biomedicine of Aging
Institute of Sport Science and Sport
Robert Bosch Medical Center
Information provided by:
University of Erlangen-Nürnberg Medical School

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

Condition or disease Intervention/treatment Phase
Frailty Sarcopenia Procedure: Power Training Procedure: Strength Training Other: Control Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Different Training Modalities and Vitamin D Supplementation on Functionality in Prefrail Elderly Persons
Study Start Date : June 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: A
Training I
Procedure: Power Training
Power training, Vitamin D substitution

Experimental: B
Training II
Procedure: Strength Training
Strength training, Vitamin D substitution

Active Comparator: C
Control
Other: Control
Vitamin D substitution, Lifestyle consultation




Primary Outcome Measures :
  1. Short physical performance battery [ Time Frame: 3 months after intervention ]

Secondary Outcome Measures :
  1. Muscle strength and muscle power [ Time Frame: 3 months after intervention ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783159


Locations
Germany
Institute of Biomedicine of Aging
Nuremberg, Germany, 90419
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Klinikum Nürnberg
Institute of Biomedicine of Aging
Institute of Sport Science and Sport
Robert Bosch Medical Center
Investigators
Principal Investigator: Cornel C. Sieber, Prof. Dr. University of Erlangen-Nürnberg
Principal Investigator: Klaus Pfeifer, Prof. Dr. University of Erlangen-Nürnberg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Cornel Sieber, Institute of Biomedicine of Aging
ClinicalTrials.gov Identifier: NCT00783159     History of Changes
Other Study ID Numbers: 32.5.8051.0113.0
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: January 2011

Keywords provided by University of Erlangen-Nürnberg Medical School:
Muscle power
Frailty
Exercise
Vitamin D

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents