Text Size

Fit in the Aged by Professional Training (FiAT)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00783159
First received: October 30, 2008
Last updated: January 11, 2011
Last verified: January 2011
History of Changes
  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 Blind (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:

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Muscle strength and muscle power [ Time Frame: 3 months after intervention ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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-Nuremberg
Principal Investigator: Klaus Pfeifer, Prof. Dr. University of Erlangen-Nuremberg
  More Information

No publications provided by University of Erlangen-Nürnberg Medical School

Additional 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
Study First Received: October 30, 2008
Last Updated: January 11, 2011
Health Authority: Germany: Ethics Commission

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
 Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013