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Fit in the Aged by Professional Training (FiAT)

Primary Purpose

Frailty, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Power Training
Strength Training
Control
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty focused on measuring Muscle power, Frailty, Exercise, Vitamin D

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Biomedicine of Aging

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

A

B

C

Arm Description

Training I

Training II

Control

Outcomes

Primary Outcome Measures

Short physical performance battery

Secondary Outcome Measures

Muscle strength and muscle power

Full Information

First Posted
October 30, 2008
Last Updated
December 10, 2020
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Klinikum Nürnberg, Institute of Biomedicine of Aging, University of Erlangen-Nürnberg, Institute of Sport Science and Sport, Robert Bosch Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00783159
Brief Title
Fit in the Aged by Professional Training
Acronym
FiAT
Official Title
The Effect of Different Training Modalities and Vitamin D Supplementation on Functionality in Prefrail Elderly Persons
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Klinikum Nürnberg, Institute of Biomedicine of Aging, University of Erlangen-Nürnberg, Institute of Sport Science and Sport, Robert Bosch Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Sarcopenia
Keywords
Muscle power, Frailty, Exercise, Vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Training I
Arm Title
B
Arm Type
Experimental
Arm Description
Training II
Arm Title
C
Arm Type
Active Comparator
Arm Description
Control
Intervention Type
Procedure
Intervention Name(s)
Power Training
Intervention Description
Power training, Vitamin D substitution
Intervention Type
Procedure
Intervention Name(s)
Strength Training
Intervention Description
Strength training, Vitamin D substitution
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Vitamin D substitution, Lifestyle consultation
Primary Outcome Measure Information:
Title
Short physical performance battery
Time Frame
3 months after intervention
Secondary Outcome Measure Information:
Title
Muscle strength and muscle power
Time Frame
3 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornel C. Sieber, Prof. Dr.
Organizational Affiliation
University of Erlangen-Nürnberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Klaus Pfeifer, Prof. Dr.
Organizational Affiliation
University of Erlangen-Nürnberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Biomedicine of Aging
City
Nuremberg
ZIP/Postal Code
90419
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
36037722
Citation
Schaupp A, 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 Aug 14;103:104792. doi: 10.1016/j.archger.2022.104792. Online ahead of print.
Results Reference
derived
PubMed Identifier
23134737
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.
Results Reference
derived
PubMed Identifier
22056537
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.
Results Reference
derived

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Fit in the Aged by Professional Training

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