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The Effect of Fluids Consumption on Balance and Gait Function in Old Adults

Primary Purpose

Aging, Dehydration

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

water consumption

About this trial

This is an interventional treatment trial for Aging focused on measuring Ageing, Balance control, Falls, dehydration

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

age 65 years old and older
independent elderly adults
do not suffer from balance problems
mini-mental score 24 and above

Exclusion Criteria:

old adults who suffer from neurological disease or stroke
old adults who suffer from psychiatric state
old adults who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb)
old adults who suffer from heart conditions
old adults who suffer from blindness

Sites / Locations

SorokaUMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

balance treatment

Arm Description

Outcomes

Primary Outcome Measures

Postural sway measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01181180

First Posted

May 27, 2010

Last Updated

June 18, 2012

Sponsor

Soroka University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01181180

Brief Title

The Effect of Fluids Consumption on Balance and Gait Function in Old Adults

Official Title

The Effect of Fluids Consumption in the Elderly on Balance and Gait Function - A Single Blind Randomized Control Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Soroka University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Experimental design overview The proposed project is a prospective experimental RCT study design. Independent old adults(age 65 years old and older) who do not suffer from balance problems willing to participate in the study will be tested before and after water consumption to explore whether there are differences in balance control as a result of dehydration.

Detailed Description

Experimental design overview The proposed project is a prospective experimental study design. independent old adults(age 65 years old and older) who do not suffer from balance problems willing to participate in the study will be tested with well-established measuring techniques of Balance control before and 2 hours after mineral water consumption (1 liter) in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins & De Luca, 1993). For each of the conditions (before and 1 hour after the use of Ritalin) in three task conditions single task; dual task (concentrating and identifying specific music); and just Listening to a relaxing music. Participants will be required to stand on the platform 10 times for 30 s. For each trial, they will be instructed to sway as little as possible.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aging, Dehydration

Keywords

Ageing, Balance control, Falls, dehydration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

balance treatment

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

water consumption

Other Intervention Name(s)

balance in older adults

Intervention Description

The effect of water consumption on postural stability of old adults (65 years old and over) will be measured using RCT study design

Primary Outcome Measure Information:

Title

Postural sway measures

Time Frame

Time 1: pre test' and hour later time 2: post testinng proceedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 65 years old and older independent elderly adults do not suffer from balance problems mini-mental score 24 and above Exclusion Criteria: old adults who suffer from neurological disease or stroke old adults who suffer from psychiatric state old adults who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb) old adults who suffer from heart conditions old adults who suffer from blindness

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melzer Itshak, PhD

Organizational Affiliation

Ben-gurion University of the Negev, Beer-Sheva, Israel

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bar-David Yair, MD

Organizational Affiliation

Soroka University Medical Centar

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Snir Yorm, MD

Organizational Affiliation

Soroka University Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

SorokaUMC

City

Beer-Sheva

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

The Effect of Fluids Consumption on Balance and Gait Function in Old Adults

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