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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01181180
First received: May 27, 2010
Last updated: June 18, 2012
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention
Aging
Dehydration
 Dietary Supplement: water consumption

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Fluids Consumption in the Elderly on Balance and Gait Function - A Single Blind Randomized Control Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Postural sway measures [ Time Frame: Time 1: pre test` and hour later time 2: post testinng proceedure ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: balance treatment Dietary Supplement: water consumption
The effect of water consumption on postural stability of old adults (65 years old and over) will be measured using RCT study design
Other Name: balance in older adults

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.

  Eligibility

Ages Eligible for Study:   65 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181180

Locations
Israel
SorokaUMC
Beer-Sheva, Israel
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Melzer Itshak, PhD Ben-gurion University of the Negev, Beer-Sheva, Israel
Study Director: Bar-David Yair, MD Soroka University Medical Centar
Study Chair: Snir Yorm, MD Soroka University Medical Center
  More Information

No publications provided

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01181180     History of Changes
Other Study ID Numbers: SOR496510CTIL, SORMBS4965
Study First Received: May 27, 2010
Last Updated: June 18, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Soroka University Medical Center:
Ageing
Balance control
Falls
dehydration

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013