StabilityEWEBNCT00708136
Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals
A study testing water based training program to improve balance in people with Stability and Balance, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The proposed project is a Randomized Controlled study design. Seniors (age >65) willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. The first 60 subjects who upon questioning were judged to meet the following inclusion criteria: 1. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- water based training program to improve balance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 37 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2006to Jun 2007
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- able to stand independently 90 seconds;
- able to walk 10 meters (with cane if necessary);
- able to understand verbal instructions.
Who cannot join
- Serious visual impairment;
- Inability to ambulate independently (cane acceptable, walker not).
- Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
- Persons with impaired communication capabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals - A Randomized Control Study
The proposed project is a Randomized Controlled study design. Seniors (age >65) willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. The first 60 subjects who upon questioning were judged to meet the following inclusion criteria:
- able to stand independently 90 seconds
- able to walk 10 meters (with cane if necessary)
- able to understand verbal instructions.
Read more
The exclusion criteria will be:
- Serious visual impairment
- Inability to ambulate independently (cane acceptable, walker not).
- Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
- Persons with impaired communication capabilities.
The whole project will be conducted over a period of 24 months. The proposed study is a randomized experimental intervention/ control group design. A total of 60 elderly volunteer subjects will be randomly assigned to two groups, exercise group (30) and control group (30). Twelve training periods will be performed with 8 subjects participating in training during each period (4 exercise groups). The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week).
Gait and balance function will be tested in both groups with well established measuring techniques before and after the training period. The measuring techniques
- Medical background variables.
- Berg Balance Scale.
- Late life Function and Disability Instrument.
- Get up and go test - stand up and walk 3 meters turn around and walk back to the chair.
- Fall Efficacy Scale
- Fall incidence and fall severity.
- 6-minute walk test. The control group will not perform any specific balance training during the 12 week period.
These individuals from control will participate in a separate exercise program after the training period.
The water training intervention is performed on different levels where each level reflects different increasing demands on the postural control system. The water exercises also include perturbation exercises that trigger specific reflex-like balance responses. On each level the instructor can instantly modify an exercise to be more or less challenging for each participant.
- Being tested
- water based training program to improve balance
- Keywords
- Falls, elderly, Balance, speed of stepping, Stability, ELDERLY FALLERS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water based training program to improve balanceBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Measured: before and 3 months after Training
Late life Function and Disability Instrument
Measured: before and after the training
Get up and go test
Measured: before and after 3 month of training
Step execution test under single and dual task
Measured: before and 3 months after Training
Stability tests
Measured: before and 3 months after Training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startJan 2006
- Primary completionJan 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StabilityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Itshak Melzer, PhD, Principal investigator, Ben-gurion University of the Negev, Beer-Sheva, Israeldagan Shvartz, MD, Study chair, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708136
- Sponsor's protocol ID
- sor404605ctil
- Other IDs
- ISRCTN4046
- Acronym
- EWEB
- Status last verified
- Nov 2005
- First submitted
- 29 Jun 2008
- Last updated
- 2 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Melzer I, Elbar O, Tsedek I, Oddsson LIe. A water-based training program that include perturbation exercises to improve stepping responses in older adults: study protocol for a randomized controlled cross-over trial. BMC Geriatr. 2008 Aug 17;8:19. doi: 10.1186/1471-2318-8-19.
PubMed 18706103
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals - A Randomized Control Study
- ClinicalTrials.gov ID
- NCT00708136
- Acronym / sponsor ID
- EWEB / sor404605ctil
- Keywords
- Falls, elderly, Balance, speed of stepping, Stability, ELDERLY FALLERS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 2 Jul 2008 (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.
The proposed project is a Randomized Controlled study design. Seniors (age >65) willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. The first 60 subjects who upon questioning were judged to meet the following inclusion criteria:
- able to stand independently 90 seconds
- able to walk 10 meters (with cane if necessary)
- able to understand verbal instructions.
The exclusion criteria will be:
- Serious visual impairment
- Inability to ambulate independently (cane acceptable, walker not).
- Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
- Persons with impaired communication capabilities.
The whole project will be conducted over a period of 24 months. The proposed study is a randomized experimental intervention/ control group design. A total of 60 elderly volunteer subjects will be randomly assigned to two groups, exercise group (30) and control group (30). Twelve training periods will be performed with 8 subjects participating in training during each period (4 exercise groups). The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week).
Gait and balance function will be tested in both groups with well established measuring techniques before and after the training period. The measuring techniques
- Medical background variables.
- Berg Balance Scale.
- Late life Function and Disability Instrument.
- Get up and go test - stand up and walk 3 meters turn around and walk back to the chair.
- Fall Efficacy Scale
- Fall incidence and fall severity.
- 6-minute walk test. The control group will not perform any specific balance training during the 12 week period.
These individuals from control will participate in a separate exercise program after the training period.
The water training intervention is performed on different levels where each level reflects different increasing demands on the postural control system. The water exercises also include perturbation exercises that trigger specific reflex-like balance responses. On each level the instructor can instantly modify an exercise to be more or less challenging for each participant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- able to stand independently 90 seconds;
- able to walk 10 meters (with cane if necessary);
- able to understand verbal instructions.
Key exclusion criteria (4 listed)
- Serious visual impairment;
- Inability to ambulate independently (cane acceptable, walker not).
- Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
- Persons with impaired communication capabilities.
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 based training program to improve balance | Behavioural | – |
Primary outcome
Berg Balance Scale
Time frame: before and 3 months after Training
Late life Function and Disability Instrument
Time frame: before and after the training
Get up and go test
Time frame: before and after 3 month of training
Step execution test under single and dual task
Time frame: before and 3 months after Training
Stability tests
Time frame: before and 3 months after Training
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 2 Jul 2008.
- Derived from this study: PubMed 18706103Melzer I, Elbar O, Tsedek I, Oddsson LIe. A water-based training program that include perturbation exercises to improve stepping responses in older adults: study protocol for a randomized controlled cross-over trial. BMC Geriatr. 2008 Aug 17;8:19. doi: 10.1186/1471-2318-8-19.
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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.
Itshak Melzer, PhD principal investigator
Ben-gurion University of the Negev, Beer-Sheva, Israel
dagan Shvartz, MD study chair
Ben-Gurion University of the Negev
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 based training program to improve balance in people with Stability and Balance, 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 3 inclusion and 4 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 2 Jul 2008. 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. 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?
Berg Balance Scale (time frame: before and 3 months after Training). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00708136, which also lists 1 linked publication.
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 2 Jul 2008.