NCT02371837

Brief Summary

The intervention will consist in a 6 week of pilates practice in older population to check the prevention of fall effectiveness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

28 days

First QC Date

February 9, 2015

Last Update Submit

June 11, 2015

Conditions

Falling Injury

Outcome Measures

Primary Outcomes (1)

  • Change in Falls Efficacy Scale International test (FES I)

    FES as measure of fear of falling or patients confident of falling

    pre intervention and post 6 weeks of intervention

Secondary Outcomes (1)

  • Change in Star Excursion Balance Test (SEBT)

    pre intervention and post 6 weeks of intervention

Study Arms (2)

pilates group

EXPERIMENTAL

Pilates based protocol for 6 weeks

Other: Pilates and fall prevention

control group

NO INTERVENTION

No treatment group

Interventions

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

pilates group

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Sensorial alteration or any disease that could altered balance. Any drug or medication that modify balance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jaén

Jaén, Andalusia, 23009, Spain

Location

Study Officials

  • Antonio Martinez, PhD

    IBIMER University of Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor.

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 26, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

ES(1)