Aging ProblemsNCT03299374
Effectiveness of the Pilates Method to Prevent and Reduce Falls in Older People
A study testing Pilates Intervention and Fall prevention intervention in people with Aging Problems, run by University of Valencia at 1 site in Spain.
Trial summary
The present research aims at evidencing the effect of one of the training methodologies increasingly demanded by the older adult, and used to promote, maintain and enhance physical and biopsychosocial aspects. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Problems
- What is being tested?
- Pilates Intervention and Fall prevention intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2017to 1 Nov 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects +60 years.
- Subjects without cognitive impairment that prevent from performing interventions. A score in the Mini-Cognitive Examination of Lobo has to be equal or greater than 20 points.
- Subjects without physical impairment that prevent from performing interventions, or can directly influence the evaluation of the balance abilities (i.e., vestibular pathologies, amputated limbs, etc.)
- Subjects willing to participate, and have read, understood and signed an informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estudio Comparativo de Los Beneficios Del Método Pilates Frente a un Programa específico de prevención de caídas
The present research aims at evidencing the effect of one of the training methodologies increasingly demanded by the older adult, and used to promote, maintain and enhance physical and biopsychosocial aspects. Consequently, we intend to base the evidence supporting Pilates as an effective method in the following specific aspects: balance, prevention and reduction of falls, and improvement of the quality of life in the older adult
- Conditions
- Aging Problems
- Being tested
- Pilates Intervention, Fall prevention intervention
- Keywords
- Pilates, Balance, Falls, Older people
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates InterventionOther
Intervention based on Pilates principles
Fall prevention interventionOther
Intervention based on principles to prevent falls
| Study group | Role | What they receive |
|---|---|---|
| Falls Group | Active comparator | Falls prevention intervention Receives: Other: Fall prevention intervention |
| Pilates Group | Experimental | Pilates intervention Receives: Other: Pilates Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls calendar
Number of falls
Measured: 1 year follow-up
Secondary outcomes (5)
Falls Efficacy Scale International
Risk of falls
Measured: change from baseline to end of intervention (4 month) and follow-up (1 year)
Timed UP and Go Test
Dynamic balance
Measured: change from baseline to end of intervention (4 month) and follow-up (1 year)
Functional Reach Test
Stability
Measured: change from baseline to end of intervention (4 month) and follow-up (1 year)
One Leg stance
Static Balance
Measured: change from baseline to end of intervention (4 month) and follow-up (1 year)
Euro Quality of Life 5 Dimension
Quality of life
Measured: change from baseline to end of intervention (4 month) and follow-up (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start15 Oct 2017
- Primary completion15 Mar 2018
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging ProblemsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose María Blasco Igual, University of Valencia
- Investigators
- Jose M Blasco, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299374
- Sponsor's protocol ID
- Pilates _FB
- Status last verified
- May 2018
- First submitted
- 26 Sep 2017
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Comparativo de Los Beneficios Del Método Pilates Frente a un Programa específico de prevención de caídas
- ClinicalTrials.gov ID
- NCT03299374
- Acronym / sponsor ID
- Pilates _FB
- Conditions
- Aging Problems
- Keywords
- Pilates, Balance, Falls, Older people
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 3 Oct 2017 (actual)
- 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 present research aims at evidencing the effect of one of the training methodologies increasingly demanded by the older adult, and used to promote, maintain and enhance physical and biopsychosocial aspects. Consequently, we intend to base the evidence supporting Pilates as an effective method in the following specific aspects: balance, prevention and reduction of falls, and improvement of the quality of life in the older adult
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Falls Group | Active comparator | Other: Fall prevention interventionFalls prevention intervention |
| Pilates Group | Experimental | Other: Pilates InterventionPilates intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects +60 years.
- Subjects without cognitive impairment that prevent from performing interventions. A score in the Mini-Cognitive Examination of Lobo has to be equal or greater than 20 points.
- Subjects without physical impairment that prevent from performing interventions, or can directly influence the evaluation of the balance abilities (i.e., vestibular pathologies, amputated limbs, etc.)
- Subjects willing to participate, and have read, understood and signed an informed consent.
Key exclusion criteria (0 listed)
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 InterventionIntervention based on Pilates principles | Other | Pilates Group |
| Fall prevention interventionIntervention based on principles to prevent falls | Other | Falls Group |
Primary outcome
Falls calendar
Time frame: 1 year follow-up
Number of falls
5 secondary outcomes
Falls Efficacy Scale International
Time frame: change from baseline to end of intervention (4 month) and follow-up (1 year)
Timed UP and Go Test
Time frame: change from baseline to end of intervention (4 month) and follow-up (1 year)
Functional Reach Test
Time frame: change from baseline to end of intervention (4 month) and follow-up (1 year)
One Leg stance
Time frame: change from baseline to end of intervention (4 month) and follow-up (1 year)
Euro Quality of Life 5 Dimension
Time frame: change from baseline to end of intervention (4 month) and follow-up (1 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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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.
Jose M Blasco, PhD principal investigator
University of Valencia
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 Intervention and Fall prevention intervention in people with Aging Problems, run by University of Valencia 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?
The sponsor lists 4 inclusion and 0 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 9 May 2018. 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?
Results are not available in the source record.
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?
Falls calendar (time frame: 1 year follow-up). 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 9 May 2018.