Feasibility Clinical Study of NLA Tool

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Elder People
• Intervention / Treatment: Behavioral: Nutrition Status Questionnaires and Physicial Function Test

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Japan
  • Ibaraki
    • Tsukuba, Ibaraki, Japan
      • Graduate School of Comprehensive Human Sciences, Tsukuba University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years to 88 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Free-living or institutionalized elderly (65-90years)

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nutrition Status and Physical Function; Nutrition questionnaire will be administered Physical functional status will be tested	Behavioral: Nutrition Status Questionnaires and Physicial Function Test; Nutrition status questionnaires will be administered, Physical functional status will be tested

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Kiyoji Tanaka, PhD, Graduate School of Comprehensive Human Sciences, Tsukuba University

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (Estimate): November 15, 2013

Study Record Updates

• Last Update Posted (Estimate): November 15, 2013
• Last Update Submitted That Met QC Criteria: November 8, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 12.33.NRC