AgingNCT01887236
The Effect of Exercise Training Programs: Step and Stability Ball on Balance and Obstacle Avoidance in Older People
A study testing Step physical activity program and Stability Ball Program in people with Aging, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Individuals of advanced age undergo both physical and cognitive deterioration. The aim of this study is to explore the effect of two types of physical activity on stability parameters. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Step physical activity program and Stability Ball Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Jan 2014
- 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
- Age above 65
- Able to undergo physical activity for 45 minutes twice a week
Who cannot join
- All Others
Trial locations and contacts
1 site in 1 country.
Israel1 site
Zinman College for Physical Education and Sport Sciences
Netanya, 42902
Ayelet Dunsky, PhD, 972-9-8639308, ayelet@wincol.ac.il
Ayelet Dunsky, PhD
About this study
Individuals of advanced age undergo both physical and cognitive deterioration. The aim of this study is to explore the effect of two types of physical activity on stability parameters.
- Conditions
- Aging
- Being tested
- Step physical activity program, Stability Ball Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step physical activity programBehavioural
Participants will take part in a biweekly, 8 week physical activity program that will include step exercises
Stability Ball ProgramBehavioural
Participants will take part in a biweekly, 8 week physical activity program that will include stability ball exercises
| Study group | Role | What they receive |
|---|---|---|
| Step Physical Activity | Active comparator | A physical activity program that is based on the Step Apparatus Training Program Receives: Behavioral: Step physical activity program |
| Stability Ball | Active comparator | A physical activity program that is based on the Stability Ball Receives: Behavioral: Stability Ball Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability
Stability will be measured with the following tests:
Timed Get Up and Go , One Leg Stand Test, Functional Reach Test,Tinetti Balance both before and after the 8 week physical activity program and the difference will be compared.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887236
- Sponsor's protocol ID
- HYMC-38-13
- Status last verified
- Jun 2013
- First submitted
- 23 Jun 2013
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Training Programs: Step and Stability Ball on Balance and Obstacle Avoidance in Older People
- ClinicalTrials.gov ID
- NCT01887236
- Acronym / sponsor ID
- HYMC-38-13
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 26 Jun 2013 (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.
Individuals of advanced age undergo both physical and cognitive deterioration. The aim of this study is to explore the effect of two types of physical activity on stability parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step Physical Activity | Active comparator | Behavioral: Step physical activity programA physical activity program that is based on the Step Apparatus Training Program |
| Stability Ball | Active comparator | Behavioral: Stability Ball ProgramA physical activity program that is based on the Stability Ball |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age above 65
- Able to undergo physical activity for 45 minutes twice a week
Key exclusion criteria (1 listed)
- All Others
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 |
|---|---|---|
| Step physical activity programParticipants will take part in a biweekly, 8 week physical activity program that will include step exercises | Behavioural | Step Physical Activity |
| Stability Ball ProgramParticipants will take part in a biweekly, 8 week physical activity program that will include stability ball exercises | Behavioural | Stability Ball |
Primary outcome
Stability
Time frame: 3 months
Stability will be measured with the following tests: Timed Get Up and Go , One Leg Stand Test, Functional Reach Test,Tinetti Balance both before and after the 8 week physical activity program and the difference will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step physical activity program and Stability Ball Program in people with Aging, run by Hillel Yaffe 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jun 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayelet Dunsky, PhD (972-9-8639308, ayelet@wincol.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability (time frame: 3 months). 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 26 Jun 2013.