Effectiveness of the Pilates Method to Prevent and Reduce... | NCT03299374

Studies
Effectiveness of the Pilates Method to Prevent and Reduce Falls in Older People

NCT03299374

Sponsor

University of Valencia

Status

Unknown status

Last Update Posted

May 9, 2018Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Aging Problems

Interventions

Pilates Intervention
Fall prevention intervention

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2017Actual

Primary Completion Date

Mar 15, 2018Actual

Completion Date

Nov 1, 2018Estimated

First Submitted Date

Sep 26, 2017

First Submission Date that Met QC Criteria

Sep 30, 2017

First Posted Date

Oct 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2018

Last Update Posted Date

May 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jose María Blasco Igual, Principal Investigator, University of ValenciaPrincipal Investigator

Lead Sponsor

University of ValenciaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Falls Group	Active Comparator	Falls prevention intervention	Other: Fall prevention intervention
Pilates Group	Experimental	Pilates intervention	Other: Pilates Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pilates Intervention	Other	Intervention based on Pilates principles	Pilates Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Falls calendar	Number of falls	1 year follow-up

Secondary Outcomes

Measure	Description	Time Frame
Falls Efficacy Scale International	Risk of falls	change from baseline to end of intervention (4 month) and follow-up (1 year)
Timed UP and Go Test	Dynamic balance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose M Blasco, PhD	University of Valencia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Valencia		Valencia		46010	Spain

Masking Info

Masking

Double

Masking Description

Participants are informed, so masking is not ensured Outcomes evaluator masked Physiotherapist none masked External adviser masked (randomization and data analysis)

Who Masked

ParticipantOutcomes Assessor