Clinical trial NCT04343300: The Effectiviness of Pilates on the Risk of Fall in Healthy Older Adults
Official title: The Effectiviness of Pilates on the Risk of Fall in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2020-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 87
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Falls Efficacy Scale
timeFrame: up to 12 weeks
measure: Platform Footworkpro Pressure plate
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Functional Reach Test (FRT)
timeFrame: Baseline, post-test 12 weeks
measure: Functional Reach Test (FRT)
timeFrame: Baseline, post-test 6 weeks
measure: Timed Up and Go (TUG)
timeFrame: Baseline, post-test 12 weeks
measure: Timed Up and Go (TUG)
timeFrame: Baseline, post-test 6 weeks
measure: GAITRite® system
timeFrame: Baseline, post-test 12 weeks
measure: GAITRite® system
timeFrame: Baseline, post-test 6 weeks
measure: The short International Physical Activity Questionnaire
timeFrame: Baseline, post-test 12 weeks
measure: The short International Physical Activity Questionnaire
timeFrame: Baseline, post-test 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: National University of Ireland, Galway
name: Larissa Donatoni da Silva, Phd student
role: PRINCIPAL_INVESTIGATOR
References: