AgingNCT01181180
The Effect of Fluids Consumption on Balance and Gait Function in Old Adults
A study testing water consumption in people with Aging and Dehydration, run by Soroka University Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Dehydration
- What is being tested?
- water consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65 years old and older
- independent elderly adults
- do not suffer from balance problems
- mini-mental score 24 and above
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fluids Consumption in the Elderly on Balance and Gait Function - A Single Blind Randomized Control Trial
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.
Read the 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.
- Conditions
- Aging, Dehydration
- Being tested
- water consumption
- Keywords
- Ageing, Balance control, Falls, dehydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water consumptionDietary supplement
Also called balance in older adults
The effect of water consumption on postural stability of old adults (65 years old and over) will be measured using RCT study design
| Study group | Role | What they receive |
|---|---|---|
| water consumation treatment | Experimental | Not described Receives: Dietary Supplement: water consumption |
| no water consumption treatment | Placebo comparator | Not described Receives: Dietary Supplement: water consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural sway measures
Measured: Time 1: pre test' and hour later time 2: post testinng proceedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melzer Itshak, PhD, Principal investigator, Ben-gurion University of the Negev, Beer-Sheva, IsraelBar-David Yair, MD, Study director, Soroka University Medical CentarSnir Yorm, MD, Study chair, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181180
- Sponsor's protocol ID
- SOR496510CTIL
- Other IDs
- SORMBS4965
- Status last verified
- Jul 2010
- First submitted
- 27 May 2010
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fluids Consumption in the Elderly on Balance and Gait Function - A Single Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01181180
- Acronym / sponsor ID
- SOR496510CTIL
- Conditions
- Aging, Dehydration
- Keywords
- Ageing, Balance control, Falls, dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| water consumation treatment | Experimental | Dietary Supplement: water consumption |
| no water consumption treatment | Placebo comparator | Dietary Supplement: water consumption |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age 65 years old and older
- independent elderly adults
- do not suffer from balance problems
- mini-mental score 24 and above
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water consumptionAlso: balance in older adultsThe effect of water consumption on postural stability of old adults (65 years old and over) will be measured using RCT study design | Dietary supplement | no water consumption treatment, water consumation treatment |
Primary outcome
Postural sway measures
Time frame: Time 1: pre test' and hour later time 2: post testinng proceedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
Related trials for Aging
Enrolling by invitationPhase 2
Tirzepatide and Organ-specific Biological Aging
Longevity, Preventive Medicine
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruiting
Vascular Aging and Lp299v Study in Healthy Adults
Vascular Aging
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melzer Itshak, PhD principal investigator
Ben-gurion University of the Negev, Beer-Sheva, Israel
Bar-David Yair, MD study director
Soroka University Medical Centar
Snir Yorm, MD study chair
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water consumption in people with Aging and Dehydration, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural sway measures (time frame: Time 1: pre test' and hour later time 2: post testinng proceedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.