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Fit in the Aged by Professional Training (FiAT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00783159
First Posted: October 31, 2008
Last Update Posted: January 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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 Procedure: Power Training Procedure: Strength Training Other: Control

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

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

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

Enrollment: 69
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

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 Submitted: October 30, 2008
First Posted: October 31, 2008
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