Feasibility Clinical Study of NLA Tool

Completed

• Conditions: Healthy Elder People
• Interventions: Behavioral: Nutrition Status Questionnaires and Physicial Function Test

• Registration Number: NCT01985282
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-22
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-08
• Last Update Submitted: 2013-11-08
• Study First Posted: 2013-11-15
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nutrition Status and Physical Function	Nutrition Status Questionnaires and Physicial Function Test	Nutrition questionnaire will be administered Physical functional status will be tested

Primary Outcome Measures

Name	Time	Method
NLA Feasibility	Day 1 of Study	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
The Segmentation of Target Population	Day 1 of Study	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)

Trial Locations

Locations (1)

Graduate School of Comprehensive Human Sciences, Tsukuba University; 🇯🇵 Tsukuba, Ibaraki, Japan