The Effectiviness of Pilates on the Risk of Fall in Healthy Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: exercise without Pilates; Other: Pilates

Detailed Description

There are a lack of studies evaluating the spatiotemporal parameters of gait, fear of falling, and physicial activity after a Pilates intervention. The inclusion criteria were healthy older adults (≥ 65 years). Demographic details: age, gender, height, weight, Body Mass Index, health status, 2 question of fear and previous falls (one year). Screening test: The Montreal cognitive MOCA test. Participants were assessed using the following fall-predictor measures. Primary outcomes: the 16-item Falls Efficacy Scale-International (FES-16), and the Footwork Pro pressure plate system. Secondary outcomes: the Timed Up and Go (TUG), the GAITRite system, the International Physical Activity Questionnaire (IPAQ), the Functional Reach Test (FRT). The randomised controlled trial, eligible n=61 participants and randomise allocated into control group (no exercise) and Pilates group. The Pilates intervention took place at the Aras Moyola building, NUI Galway.The instructor is fully qualified to carry out the Pilates programme. The instructor is a qualified physiotherapist and has undertaken courses clinical Pilates in Valeria Figueireido International and Body Control Pilates for older adults. The video and booklet were built by the PI. The booklet contains pictures demonstrated by the instructor. Participants also had access to the home-based Pilates exercise video via a Dropbox link sent to their email by PI. The instructor demonstrated, explained and showed the exercises through the video to the participants during the first supervised Pilates class which participants also performed the home-based exercises. Feedback notes and comments were also taken from the participants. The participants were asked to give feedback on the same day as the assessments (Post-test). Questionnaire of Pilates exercises applied for the participants after Pilates 24 sessions supervised completed and a diary calendar of falls during the period of the intervention of 12 weeks, phone calls and e-mails were provided by the PI.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 87 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Control group; Control group without Pilates exercise during 12 weeks Participants were advised to keep their routine Falls diary calendar	Other: exercise without Pilates; exercise without Pilates
EXPERIMENTAL: Pilates group; 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; Intervention of12 weeks of Pilates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Reach Test (FRT)	Mobility and balance	Baseline, post-test 12 weeks
Functional Reach Test (FRT)	Mobility and balance	Baseline, post-test 6 weeks
Timed Up and Go (TUG)	Functional mobility	Baseline, post-test 12 weeks
Timed Up and Go (TUG)	Functional mobility	Baseline, post-test 6 weeks
GAITRite® system	Spatial and temporal parameters of gait	Baseline, post-test 12 weeks
GAITRite® system	Spatial and temporal parameters of gait	Baseline, post-test 6 weeks
The short International Physical Activity Questionnaire	Measure daily physical activity such as leisure time, domestic and gardening (yard) activities, work-related and transport-related activities. The total scores of walking; moderate, and vigorous-intensity activity described the overall level of activity in (METs) metabolic equivalent minutes per week, calculates as the MET intensity multiplied per min for each activity during the last seven days such as walking=3.3 METs, Moderate PA= 4.0 METs and Vigorous PA= 8.0 METs. The total MET min/week = (walk MET*min*days) + (Mod MET*min*days) +Vig METs*min*days) (http://www.ipaq.ki.se).	Baseline, post-test 12 weeks
The short International Physical Activity Questionnaire	Measure daily physical activity such as leisure time, domestic and gardening (yard) activities, work-related and transport-related activities. The total scores of walking; moderate, and vigorous-intensity activity described the overall level of activity in (METs) metabolic equivalent minutes per week, calculates as the MET intensity multiplied per min for each activity during the last seven days such as walking=3.3 METs, Moderate PA= 4.0 METs and Vigorous PA= 8.0 METs. The total MET min/week = (walk MET*min*days) + (Mod MET*min*days) +Vig METs*min*days) (http://www.ipaq.ki.se).	Baseline, post-test 6 weeks

Collaborators and Investigators

• Sponsor: National University of Ireland, Galway, Ireland
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Investigators: Principal Investigator: Larissa Donatoni da Silva, Phd student, National University of Ireland, Galway

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (ACTUAL): April 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: LdaSilva; CAPES (OTHER_GRANT: Coordenação de Aperfeiçoamento de Pessoal de Nivel Superior)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: check

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No