NCT04343300

Brief Summary

This research examine the effectiveness of a Pilates intervention for reducing the risk of falls among adults aged over 65 years. The effects were measured the Pilates classes with a supplementary home-based exercises in two phases: Phase I investigated (Mat Pilates supervised with a supplementary home-based Pilates exercise for the pre and post-test of 6 weeks intervention. Eligible 32 participants). The main study randomised controlled trial (phase II) investigate whether a Pilates intervention of 12 weeks with a supplementary at home program is effective in reducing falls risk factors. Pilates group which practiced Pilates and the control group which did not practice Pilates The aim of the study is to identify whether spatiotemporal gait parameters, mobility, postural stability parameters of anteroposterior and mediolateral (AP-ML), functional mobility, fear of falling and physical activity changes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable healthy

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

January 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
Last Updated

September 2, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

April 9, 2020

Last Update Submit

August 31, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Falls Efficacy Scale

    Participants should answer items thinking about how they usually do the activity and they should answer items to show how concerned they would be about falling: 1 = not at all concerned 2 = somewhat concerned 3 = fairly concerned 4 = very concerned. Total score ranging from 16 (not at all) to 64 (very much).

    up to 12 weeks

  • Platform Footworkpro Pressure plate

    Measure the two parameters of stabilometry in mediolateral (cm) and anteroposterior (cm) sway in static position performance

    up to 12 weeks

Secondary Outcomes (8)

  • Functional Reach Test (FRT)

    Baseline, post-test 12 weeks

  • Functional Reach Test (FRT)

    Baseline, post-test 6 weeks

  • Timed Up and Go (TUG)

    Baseline, post-test 12 weeks

  • Timed Up and Go (TUG)

    Baseline, post-test 6 weeks

  • GAITRite® system

    Baseline, post-test 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Control group

OTHER

Control group without Pilates exercise during 12 weeks Participants were advised to keep their routine Falls diary calendar

Other: exercise without Pilates

Pilates group

EXPERIMENTAL

Pilates classes were held twice weekly for one hour. The classes were divided into a warm-up, mat Pilates with accessories and a cool-down. Participants used small items of equipment such as bands, circles or rings, blocks, spyke balls and foam rollers. The intervention lasted 12 weeks; the classes were supervised twice a week. The supervised exercises were evaluated every four weeks (frequency and intensity) focused on the lower limb (muscles related to gait), core and trunk (muscles related to posture). The participants were asked to perform supplementary at-home workouts three times a week using a booklet and video that was provided to the participants. The video and booklet to introduce the six principles of Pilates, warm-up exercises, exercises on the chair, mat Pilates exercises and cool-down exercises. Participants were advised to perform these exercises three times a week for 30 minutes at home.

Other: Pilates

Interventions

PilatesOTHER

Intervention of12 weeks of Pilates

Pilates group

exercise without Pilates

Control group

Eligibility Criteria

Age65 Years - 87 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Those over 65 years older, both male and female, healthy and able to attend the Pilates sessions regularly were included. Those included had not had surgery in the past six months, had no restriction recommended by their General Practitioner and had a Montreal Cognitive Assessment score of over 26

You may not qualify if:

  • Those excluded had a MOCA score of less than 26, had a fall in the last six months. had several pain, had acute inflammation, had a history of neurological illness, had medical and pharmacologic contraindications to exercise, vertigo or had a strong exercise routine already.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Exercise Movement TechniquesExercise

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Larissa Donatoni da Silva, Phd student

    National University of Ireland, Galway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 13, 2020

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

December 1, 2018

Last Updated

September 2, 2020

Record last verified: 2020-04