Fit in the Aged by Professional Training (FiAT)

December 10, 2020 updated by: University of Erlangen-Nürnberg Medical School

The Effect of Different Training Modalities and Vitamin D Supplementation on Functionality in Prefrail Elderly Persons

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Nuremberg, Germany, 90419
        • Institute of Biomedicine of Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Short physical performance battery
Time Frame: 3 months after intervention
3 months after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Muscle strength and muscle power
Time Frame: 3 months after intervention
3 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

University of Erlangen-Nürnberg
Robert Bosch Medical Center
Klinikum Nürnberg
Institute of Biomedicine of Aging
Institute of Sport Science and Sport

Investigators

  • Principal Investigator: Cornel C. Sieber, Prof. Dr., University of Erlangen-Nürnberg
  • Principal Investigator: Klaus Pfeifer, Prof. Dr., University of Erlangen-Nürnberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 30, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32.5.8051.0113.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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