Falling InjuryNCT02371837
Effects of Pilates in Risk Fall in Older Population
A study testing Pilates and fall prevention in people with Falling Injury, run by University of Jaén at 1 site in Spain.
Trial summary
The intervention will consist in a 6 week of pilates practice in older population to check the prevention of fall effectiveness. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Falling Injury
- What is being tested?
- Pilates and fall prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2015to Apr 2015
- 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: - Elder population. Not to be a pilates practitioner previous to study enrollment. Exclusion Criteria: - Cognitive issues that dont allow to practice pilates method.
Sensorial alteration or any disease that could altered balance. Any drug or medication that modify balance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 6 Week of Pilates in Fall Prevention
The intervention will consist in a 6 week of pilates practice in older population to check the prevention of fall effectiveness.
Read the detailed description
A study population of elder people will be randomly allocated to intervention or control group, consisted in Pilates and a booklet of balance tips respectively.
The protocol will be performed for 6 weeks.
- Conditions
- Falling Injury
- Being tested
- Pilates and fall prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates and fall preventionOther
A 2 days per week during 6 week Pilates practice will be performed in experimental group in order to check the effectiveness in fall prevention
| Study group | Role | What they receive |
|---|---|---|
| pilates group | Experimental | Pilates based protocol for 6 weeks Receives: Other: Pilates and fall prevention |
| control group | No intervention | No treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Falls Efficacy Scale International test (FES I)
FES as measure of fear of falling or patients confident of falling
Measured: pre intervention and post 6 weeks of intervention
Secondary outcomes (1)
Change in Star Excursion Balance Test (SEBT)
SEBT as measure of dynamic balance
Measured: pre intervention and post 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falling InjuryStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAVID CRUZ DÍAZ, University of Jaén
- Investigators
- Antonio Martinez, PhD, Principal investigator, IBIMER University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371837
- Sponsor's protocol ID
- UJA2015
- Status last verified
- Jun 2015
- First submitted
- 9 Feb 2015
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 6 Week of Pilates in Fall Prevention
- ClinicalTrials.gov ID
- NCT02371837
- Acronym / sponsor ID
- UJA2015
- Conditions
- Falling Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Feb 2015 (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 intervention will consist in a 6 week of pilates practice in older population to check the prevention of fall effectiveness.
Detailed description
A study population of elder people will be randomly allocated to intervention or control group, consisted in Pilates and a booklet of balance tips respectively.
The protocol will be performed for 6 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pilates group | Experimental | Other: Pilates and fall preventionPilates based protocol for 6 weeks |
| control group | No intervention | –No treatment group |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Pilates and fall preventionA 2 days per week during 6 week Pilates practice will be performed in experimental group in order to check the effectiveness in fall prevention | Other | pilates group |
Primary outcome
Change in Falls Efficacy Scale International test (FES I)
Time frame: pre intervention and post 6 weeks of intervention
FES as measure of fear of falling or patients confident of falling
1 secondary outcome
Change in Star Excursion Balance Test (SEBT)
Time frame: pre intervention and post 6 weeks of intervention
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 12 Jun 2015.
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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.
Antonio Martinez, PhD principal investigator
IBIMER University of Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates and fall prevention in people with Falling Injury, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Jun 2015. 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 Spain. 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?
Change in Falls Efficacy Scale International test (FES I) (time frame: pre intervention and post 6 weeks of intervention). 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 12 Jun 2015.