NCT00783159

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

October 30, 2008

Last Update Submit

December 10, 2020

Conditions

FrailtySarcopenia

Keywords

Muscle powerFrailtyExerciseVitamin D

Outcome Measures

Primary Outcomes (1)

  • Short physical performance battery

    3 months after intervention

Secondary Outcomes (1)

  • Muscle strength and muscle power

    3 months after intervention

Study Arms (3)

A

EXPERIMENTAL

Training I

Procedure: Power Training

B

EXPERIMENTAL

Training II

Procedure: Strength Training

C

ACTIVE COMPARATOR

Control

Other: Control

Interventions

Power TrainingPROCEDURE

Power training, Vitamin D substitution

A
Strength TrainingPROCEDURE

Strength training, Vitamin D substitution

B
ControlOTHER

Vitamin D substitution, Lifestyle consultation

C

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Prefrailty according to the frailty score of Fried

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Biomedicine of Aging

Nuremberg, 90419, Germany

Location

Related Publications (4)

  • 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.

    PMID: 41397660DERIVED

  • Schaupp 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.

    PMID: 36037722DERIVED

  • 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.

    PMID: 23134737DERIVED

  • 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.

    PMID: 22056537DERIVED

MeSH Terms

Conditions

FrailtySarcopeniaMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cornel C. Sieber, Prof. Dr.

    University of Erlangen-Nürnberg

    PRINCIPAL INVESTIGATOR

  • Klaus Pfeifer, Prof. Dr.

    University of Erlangen-Nürnberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2008

First Posted

October 31, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2009

Study Completion

May 1, 2010

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations

DE(1)