NCT01181180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 19, 2024

Status Verified

July 1, 2010

Enrollment Period

1.4 years

First QC Date

May 27, 2010

Last Update Submit

April 17, 2024

Conditions

AgingDehydration

Keywords

AgeingBalance controlFallsdehydration

Outcome Measures

Primary Outcomes (1)

  • Postural sway measures

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

Study Arms (2)

water consumation treatment

EXPERIMENTAL
Dietary Supplement: water consumption

no water consumption treatment

PLACEBO COMPARATOR
Dietary Supplement: water consumption

Interventions

water consumptionDIETARY_SUPPLEMENT

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

Also known as: balance in older adults
no water consumption treatmentwater consumation treatment

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SorokaUMC

Beersheba, Israel

Location

MeSH Terms

Conditions

Dehydration

Interventions

DrinkingAging

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EatingNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological PhenomenaGrowth and Development

Study Officials

  • Melzer Itshak, PhD

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

    PRINCIPAL INVESTIGATOR

  • Bar-David Yair, MD

    Soroka University Medical Centar

    STUDY DIRECTOR

  • Snir Yorm, MD

    Soroka University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2010

First Posted

August 13, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 19, 2024

Record last verified: 2010-07

Locations

IL(1)