Nutrition and Frailty in Older Persons

This study has been completed.
Sponsor:
Collaborator:
Nestlé
Information provided by (Responsible Party):
dorothee volkert, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01433211
First received: September 7, 2011
Last updated: September 11, 2011
Last verified: September 2011
  Purpose

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


Condition
Frailty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Relation Between Nutrition and Frailty in Community-dwelling Older Persons

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Frailty (according to Fried et al.) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • Impaired physical performance (according to Guralnik et al.) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    Impaired physical performance is definded as less than 9 points in the Short Physical Performance Battery (SPPB).

    Three physical performance tests (balance, walking speed and chair-rise) are performed in a standardised manner and rated with 0-4 points each. SPPB is the sum score of these three test resuslts with a maximum of 12 points indicating the best physical performance.



Enrollment: 206
Study Start Date: August 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment

Detailed Description:

Nutrition is regarded as an important etiologic factor in the development of frailty in older adults. To date the relation between nutrition and frailty is only poorly described.

Thus, it is the purpose of this study to investigate the association between different nutrition characteristics and frailty in older community-living persons.

206 volunteers aged 75 years or older were included in this cross-sectional study. Nutritional assessment included the Mini-Nutritional Assessment (MNA), a food-frequency questionnaire and a standardised three-day dietary record. Intake of energy and nutrients was calculated using the German nutrient database BLS II.2. Dietary patterns were described by different dietary scores. Frailty was defined according to Fried et al. based on the following criteria: weight loss, exhaustion, grip strength, walking speed and physical activity. In addition several standardised tests were performed to characterise physical performance (Timed Up & Go, repeated chair stands, balance tests).

The association between nutritional aspects and physical performance is evaluated in an explorative manner.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Community-living persons aged 75 years or older

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • acute illness
  • cognitive impairment (Mini Mental State Examination ≥ 24 out of 30 points)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433211

Locations
Germany
Institute for Biomedicine of Aging, University of Erlangen-Nürnberg
Nürnberg, Germany, 90419
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Nestlé