Quality of LifeNCT01379235
Association Between Pilatis Exercise, Balance and Stability Measurements, and Quality of Life Among Elderly Population
A study testing Pilatis exercise in people with Quality of Life and Accidental Falls, run by Meir Medical Center at 1 site in Israel.
Trial summary
Background: The elderly population in western countries and in Israel is constantly growing. Falls are one of the common problems among this population. Thus there is a need for falls prevention exercise program to be offered in the different settings elderly reside. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Quality of Life, Accidental Falls
- What is being tested?
- Pilatis exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Jul 2013
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- Man and Women aged 65 years old and above
- Able to walk independently without devices (cane is exceptable)
Who cannot join
- Unstable diseases (unstable angina; heart failure- NIHA 3 or 4; lung disease with shortness of breath on light effort; end stage liver and kidney diseases; terminal malignant diseases)
- MMSE less then 24
- After hip or knee surgery
- After lower limb amputation
- Neurological diseases with significant gait and balance instability.
Trial locations and contacts
1 site in 1 country.
About this study
Background: The elderly population in western countries and in Israel is constantly growing. Falls are one of the common problems among this population. Thus there is a need for falls prevention exercise program to be offered in the different settings elderly reside. Most methods for physical exercise are dedicated to muscle strengthening and improving balance by strengthening external muscles. Pilatis exercise program focuses mainly on strengthening the in-depth muscles. The advantage of this method is in its simplicity and availability. This method is suitable also for special populations as patients in acute hospitalization. In this study, the investigators will evaluate if the pilatis exercise can improve balance of elderly population. Physical exercise usually improves the mood. Like any physical exercise, Pilatis exercise has a mental advantage, therefore, this study will also examine if pilatis exercise can improve quality of life of elderly population.
Working hypothesis and aims: Pilatis exercise will improve balance and stability measurements, and quality of life among elderly population.
Read more
Methods: Randomized, prospective study among elderly patients aged 65 and above belonging to Clalit Health Services primary care clinic . Participants of the intervention and control group will receive a brochure that will include nutrition and healthy life style recommendations. Intervention group: will receive 12 weeks of pilatis exercise 3 times a week. The control group will be offered the same intervention at the end of the study period. Balance evaluation will be performed using the: Tinetti Balance Gait Scale, Berg Balance Scale, Multidirectional Reach Test, Timed Up and Go, Step execution test. The SF-36 questionnaire will be use to evaluate quality of life.
Importance: This study will examine the influence of pilatis exercise on balance among the elderly. If findings will determine that pilatis does improve balance in the elderly, the investigators can further examine pilatis's influence on falls prevention, and minimizing falls damages.
Probable implications to the welfare and health of the aged population:
Improving balance, falls preventing and minimizing falls damages among elderly; improvement in elderly quality of life.
- Conditions
- Quality of Life, Accidental Falls
- Being tested
- Pilatis exercise
- Keywords
- independent 65 years old and above
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilatis exerciseOther
12 weeks of pilatis exercise 3 times a week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group: will receive 12 weeks of pilatis exercise 3 times a week. Receives: Other: Pilatis exercise |
| control group | Other | The control group will be offered the same intervention (pilatis exercise) at the end of the study period. Receives: Other: Pilatis exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
postural stability test
Statistically significance difference in postural stability test will be found when comparing pre and post intervention results in the intervention group of the Step execution test. This outcome is a combination of the variables: elliptical area(mm2), sway velocity (mm/s), mediolateral sway (mm)and anterior posterior sway (mm).
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 posted23 Jun 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Press, MD, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379235
- Sponsor's protocol ID
- MMC105809KCTIL
- Status last verified
- Jun 2012
- First submitted
- 15 Feb 2011
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Pilatis Exercise, Balance and Stability Measurements, and Quality of Life Among Elderly Population
- ClinicalTrials.gov ID
- NCT01379235
- Acronym / sponsor ID
- MMC105809KCTIL
- Conditions
- Quality of Life, Accidental Falls
- Keywords
- independent 65 years old and above
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Jun 2011 (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.
Background: The elderly population in western countries and in Israel is constantly growing. Falls are one of the common problems among this population. Thus there is a need for falls prevention exercise program to be offered in the different settings elderly reside. Most methods for physical exercise are dedicated to muscle strengthening and improving balance by strengthening external muscles. Pilatis exercise program focuses mainly on strengthening the in-depth muscles. The advantage of this method is in its simplicity and availability. This method is suitable also for special populations as patients in acute hospitalization. In this study, the investigators will evaluate if the pilatis exercise can improve balance of elderly population. Physical exercise usually improves the mood. Like any physical exercise, Pilatis exercise has a mental advantage, therefore, this study will also examine if pilatis exercise can improve quality of life of elderly population.
Working hypothesis and aims: Pilatis exercise will improve balance and stability measurements, and quality of life among elderly population.
Methods: Randomized, prospective study among elderly patients aged 65 and above belonging to Clalit Health Services primary care clinic . Participants of the intervention and control group will receive a brochure that will include nutrition and healthy life style recommendations. Intervention group: will receive 12 weeks of pilatis exercise 3 times a week. The control group will be offered the same intervention at the end of the study period. Balance evaluation will be performed using the: Tinetti Balance Gait Scale, Berg Balance Scale, Multidirectional Reach Test, Timed Up and Go, Step execution test. The SF-36 questionnaire will be use to evaluate quality of life.
Importance: This study will examine the influence of pilatis exercise on balance among the elderly. If findings will determine that pilatis does improve balance in the elderly, the investigators can further examine pilatis's influence on falls prevention, and minimizing falls damages.
Probable implications to the welfare and health of the aged population:
Improving balance, falls preventing and minimizing falls damages among elderly; improvement in elderly quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Pilatis exerciseIntervention group: will receive 12 weeks of pilatis exercise 3 times a week. |
| control group | Other | Other: Pilatis exerciseThe control group will be offered the same intervention (pilatis exercise) at the end of the study period. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Man and Women aged 65 years old and above
- Able to walk independently without devices (cane is exceptable)
Key exclusion criteria (5 listed)
- Unstable diseases (unstable angina; heart failure- NIHA 3 or 4; lung disease with shortness of breath on light effort; end stage liver and kidney diseases; terminal malignant diseases)
- MMSE less then 24
- After hip or knee surgery
- After lower limb amputation
- Neurological diseases with significant gait and balance instability.
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 |
|---|---|---|
| Pilatis exercise12 weeks of pilatis exercise 3 times a week. | Other | Intervention group, control group |
Primary outcome
postural stability test
Time frame: 3 months
Statistically significance difference in postural stability test will be found when comparing pre and post intervention results in the intervention group of the Step execution test. This outcome is a combination of the variables: elliptical area(mm2), sway velocity (mm/s), mediolateral sway (mm)and anterior posterior sway (mm).
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 Nov 2014.
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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.
Yan Press, MD principal investigator
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 Pilatis exercise in people with Quality of Life and Accidental Falls, run by Meir 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 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 Nov 2014. 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?
postural stability test (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 19 Nov 2014.