NCT03299374

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

October 15, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

September 26, 2017

Last Update Submit

May 8, 2018

Conditions

Keywords

PilatesBalanceFallsOlder people

Outcome Measures

Primary Outcomes (1)

  • Falls calendar

    Number of falls

    1 year follow-up

Secondary Outcomes (5)

  • Falls Efficacy Scale International

    change from baseline to end of intervention (4 month) and follow-up (1 year)

  • Timed UP and Go Test

    change from baseline to end of intervention (4 month) and follow-up (1 year)

  • Functional Reach Test

    change from baseline to end of intervention (4 month) and follow-up (1 year)

  • One Leg stance

    change from baseline to end of intervention (4 month) and follow-up (1 year)

  • Euro Quality of Life 5 Dimension

    change from baseline to end of intervention (4 month) and follow-up (1 year)

Study Arms (2)

Falls Group

ACTIVE COMPARATOR

Falls prevention intervention

Other: Fall prevention intervention

Pilates Group

EXPERIMENTAL

Pilates intervention

Other: Pilates Intervention

Interventions

Intervention based on Pilates principles

Pilates Group

Intervention based on principles to prevent falls

Falls Group

Eligibility Criteria

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Study Officials

  • Jose M Blasco, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants are informed, so masking is not ensured Outcomes evaluator masked Physiotherapist none masked External adviser masked (randomization and data analysis)
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 3, 2017

Study Start

October 15, 2017

Primary Completion

March 15, 2018

Study Completion

November 1, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations