NCT01433211

Brief Summary

The purpose of this study is to investigate the association between nutrition and frailty in older community-living persons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

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

August 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

September 7, 2011

Last Update Submit

May 7, 2024

Conditions

Frailty

Outcome Measures

Primary Outcomes (1)

  • Frailty (according to Fried et al.)

    Frailty is defined as the presence of at least 3 of the following criteria: * self-reported weight loss of more than 4.5 kg in the last year * exhaustion (self-reported feeling that everything was an effort or one could not get "going" \> 2 times a week) * low grip strength (men ≤ 29-32 kg, women ≤ 17-21 kg depending on BMI), * low walking speed (\> 6-7 sec/ 4.57 m, depending on gender and height) * low physical activity (men \< 383 kcal/ week, women \< 270 kcal/ week)

    1 day

Secondary Outcomes (1)

  • Impaired physical performance (according to Guralnik et al.)

    1 day

Study Arms (1)

No treatment

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Community-living persons aged 75 years or older

You may qualify if:

  • age of 75 years and older
  • living independently at home

You may not qualify if:

  • acute illness
  • cognitive impairment (Mini Mental State Examination ≥ 24 out of 30 points)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Biomedicine of Aging, University of Erlangen-Nürnberg

Nuremberg, 90419, Germany

Location

Related Publications (2)

  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PMID: 11253156BACKGROUND

  • Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

    PMID: 8126356BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 13, 2011

Study Start

August 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations

DE(1)