FrailtyFiATNCT00783159
Fit in the Aged by Professional Training
A study testing Power Training and Strength Training in people with Frailty and Sarcopenia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This intervention study tests training methods to stabilize or improve functionality in the high risk group of prefrail elderly persons. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Sarcopenia
- What is being tested?
- Power Training and Strength Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Prefrailty according to the frailty score of Fried
Who cannot join
- Sarcoidosis
- Nephrolithiasis
- Plasmacytoma
- COPD
- Inflammatory bowel disease
- Rheumatoid arthritis
Show all 13Show fewer
- History of cancer
- Instable heart disease
- Depression (GDS>=6)
- Dementia (MMSE<=24)
- BMI>35kg/m²
- Current attendance of muscle training
- Medication: immunosuppressive drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Frailty, Sarcopenia
- Being tested
- Power Training, Strength Training, Control
- Keywords
- Muscle power, Frailty, Exercise, Vitamin D
- Medical subject headings
- Frailty, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power TrainingProcedure or surgery
Power training, Vitamin D substitution
Strength TrainingProcedure or surgery
Strength training, Vitamin D substitution
ControlOther
Vitamin D substitution, Lifestyle consultation
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Training I Receives: Procedure: Power Training |
| B | Experimental | Training II Receives: Procedure: Strength Training |
| C | Active comparator | Control Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short physical performance battery
Measured: 3 months after intervention
Secondary outcomes (1)
Muscle strength and muscle power
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Nürnberg, Institute of Biomedicine of Aging, University of Erlangen-Nürnberg, Institute of Sport Science and Sport, Robert Bosch Medical Center
- Responsible party
- Sponsor
- Investigators
- Cornel C. Sieber, Prof. Dr., Principal investigator, University of Erlangen-NürnbergKlaus Pfeifer, Prof. Dr., Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783159
- Sponsor's protocol ID
- 32.5.8051.0113.0
- Acronym
- FiAT
- Status last verified
- Dec 2020
- First submitted
- 30 Oct 2008
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Rippl M, Bidlingmaier M, Deissler L, Martini S, Mueller K, Schluessel S, Schmidmaier R, Schweizer JROL, Tausendfreund O, Welscher L, Drey M. Strength but not power training increases soluble alpha klotho levels in pre-frail older adults. Exp Gerontol. 2026 Jan;213:113002. doi: 10.1016/j.exger.2025.113002. Epub 2025 Dec 13.
PubMed 41397660Schaupp A, Bidlingmaier M, 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 Nov-Dec;103:104792. doi: 10.1016/j.archger.2022.104792. Epub 2022 Aug 14.
PubMed 36037722Zech 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.
PubMed 23134737Drey 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.
PubMed 22056537
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Training Modalities and Vitamin D Supplementation on Functionality in Prefrail Elderly Persons
- ClinicalTrials.gov ID
- NCT00783159
- Acronym / sponsor ID
- FiAT / 32.5.8051.0113.0
- Conditions
- Frailty, Sarcopenia
- Keywords
- Muscle power, Frailty, Exercise, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Klinikum Nürnberg, Institute of Biomedicine of Aging, University of Erlangen-Nürnberg, Institute of Sport Science and Sport, Robert Bosch Medical Center
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Power TrainingTraining I |
| B | Experimental | Procedure: Strength TrainingTraining II |
| C | Active comparator | Other: ControlControl |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Prefrailty according to the frailty score of Fried
Key exclusion criteria (13 listed)
- Sarcoidosis
- Nephrolithiasis
- Plasmacytoma
- COPD
- Inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power TrainingPower training, Vitamin D substitution | Procedure or surgery | A |
| Strength TrainingStrength training, Vitamin D substitution | Procedure or surgery | B |
| ControlVitamin D substitution, Lifestyle consultation | Other | C |
Primary outcome
Short physical performance battery
Time frame: 3 months after intervention
1 secondary outcome
Muscle strength and muscle power
Time frame: 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Derived from this study: PubMed 41397660Rippl M, Bidlingmaier M, Deissler L, Martini S, Mueller K, Schluessel S, Schmidmaier R, Schweizer JROL, Tausendfreund O, Welscher L, Drey M. Strength but not power training increases soluble alpha klotho levels in pre-frail older adults. Exp Gerontol. 2026 Jan;213:113002. doi: 10.1016/j.exger.2025.113002. Epub 2025 Dec 13.
- Derived from this study: PubMed 36037722Schaupp A, Bidlingmaier M, 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 Nov-Dec;103:104792. doi: 10.1016/j.archger.2022.104792. Epub 2022 Aug 14.
- Derived from this study: PubMed 23134737Zech 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.
- Derived from this study: PubMed 22056537Drey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornel C. Sieber, Prof. Dr. principal investigator
University of Erlangen-Nürnberg
Klaus Pfeifer, Prof. Dr. principal investigator
University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power Training and Strength Training in people with Frailty and Sarcopenia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short physical performance battery (time frame: 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00783159, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.