Clinical Trials Logo
  1. Home
  2. Healthy Elder People
  3. NCT01985282
  4. Details
NCT01985282 Clinical Trial

Feasibility Clinical Study of NLA Tool

Healthy Elder People Clinical Trial

Official title:
Evaluate the Feasibility of the NLA Tool, a Combined Assessment of Nutritional and Physical Functional Status, to Provide Personalized Advice for the Independence and Mobility of Elderly.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01985282
Other study ID # 12.33.NRC
Secondary ID
Status Completed
Phase N/A
First received April 22, 2013
Last updated November 8, 2013
Start date March 2013
Est. completion date June 2013

Study information
Verified date November 2013
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

The study is to evaluate the feasibility of the NLA tool, a combined assessment of nutritional and physical functional status, to provide personalized advice for the independence and mobility of elderly.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years to 90 Years
Eligibility Inclusion Criteria:

1. aged between 65 and 90 years,

2. able to walk with or without walking aid,

3. having obtained the subject's written informed consent

4. free of cognitive impairment,

Exclusion Criteria:

1. restricted by a doctor to exercise.

2. unable to carry out performance tests and questionnaires correctly,

3. lower or upper extremity surgery or fracture in the last 3 months

4. having history of neurological disease (e.g., Parkinson disease, stroke) with residual impairment

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Behavioral:
• Nutrition Status Questionnaires and Physicial Function Test
Nutrition status questionnaires will be administered, Physical functional status will be tested

Locations
Country Name City State
Japan Graduate School of Comprehensive Human Sciences, Tsukuba University Tsukuba Ibaraki

Sponsors (1)
Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary NLA Feasibility Determining the proportion of elderly subjects (by statistical approach) who, according to the NLA result, would qualify for a personalized program to improve their nutritional and physical status Day 1 of Study No
Primary The Segmentation of Target Population Determining the segmentation (defined by cut-off criteria) of these elderly subjects stratified into 3 NLA subgroups according to strength (By measuring upper and lower extremity strength) and endurance performance (By measuring 6 minutes walking distantce) (33% +/- 10% of target group) Day 1 of Study No