Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01181180
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : June 19, 2012
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Aging Dehydration Dietary Supplement: water consumption Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : July 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Postural sway measures [ Time Frame: Time 1: pre test` and hour later time 2: post testinng proceedure ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181180


Locations
Layout table for location information
Israel
SorokaUMC
Beer-Sheva, Israel
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01181180    
Other Study ID Numbers: SOR496510CTIL
SORMBS4965 ( Other Grant/Funding Number: Goldman fundation )
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: July 2010
Keywords provided by Soroka University Medical Center:
Ageing
Balance control
Falls
dehydration
Additional relevant MeSH terms:
Layout table for MeSH terms
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes