Nutrition and Frailty in Older Persons

Frailty Clinical Trial

Official title:

Relation Between Nutrition and Frailty in Community-dwelling Older Persons

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433211
• Other study ID #: IBA-2011(1)
• Status: Completed
• Start date: August 2009
• Est. completion date: September 2010

Study information

• Verified date: May 2024
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Frailty

Locations

Country	Name	City	State
Germany	Institute for Biomedicine of Aging, University of Erlangen-Nürnberg	Nürnberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impaired physical performance (according to Guralnik et al.)	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.	1 day