HealthyNCT04343300
The Effectiviness of Pilates on the Risk of Fall in Healthy Older Adults
A study testing Pilates and exercise without Pilates in people with Healthy, run by National University of Ireland, Galway, Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 87 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pilates and exercise without Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 87 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Pilates, exercise without Pilates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
Intervention of12 weeks of Pilates
exercise without PilatesOther
exercise without Pilates
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Control group without Pilates exercise during 12 weeks Participants were advised to keep their routine Falls diary calendar Receives: 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. Receives: Other: Pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: up to 12 weeks
Secondary outcomes (8)
Functional Reach Test (FRT)
Mobility and balance
Measured: Baseline, post-test 12 weeks
Functional Reach Test (FRT)
Mobility and balance
Measured: Baseline, post-test 6 weeks
Timed Up and Go (TUG)
Functional mobility
Measured: Baseline, post-test 12 weeks
Timed Up and Go (TUG)
Functional mobility
Measured: Baseline, post-test 6 weeks
GAITRite® system
Spatial and temporal parameters of gait
Measured: Baseline, post-test 12 weeks
GAITRite® system
Spatial and temporal parameters of gait
Measured: 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).
Measured: 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).
Measured: Baseline, post-test 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study startJan 2016
- Primary completionJun 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Larissa Donatoni da Silva, National University of Ireland, Galway, Ireland
- Investigators
- Larissa Donatoni da Silva, Phd student, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343300
- Sponsor's protocol ID
- LdaSilva
- Other IDs
- CAPES
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided: check
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiviness of Pilates on the Risk of Fall in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT04343300
- Acronym / sponsor ID
- LdaSilva
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: exercise without PilatesControl group without Pilates exercise during 12 weeks Participants were advised to keep their routine Falls diary calendar |
| Pilates group | Experimental | Other: PilatesPilates 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. |
Who may qualify
- Ages
- 65 to 87 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PilatesIntervention of12 weeks of Pilates | Other | Pilates group |
| exercise without Pilatesexercise without Pilates | Other | Control group |
Primary outcome
Falls Efficacy Scale
Time frame: up to 12 weeks
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).
Platform Footworkpro Pressure plate
Time frame: up to 12 weeks
Measure the two parameters of stabilometry in mediolateral (cm) and anteroposterior (cm) sway in static position performance
8 secondary outcomes
Functional Reach Test (FRT)
Time frame: Baseline, post-test 12 weeks
Functional Reach Test (FRT)
Time frame: Baseline, post-test 6 weeks
Timed Up and Go (TUG)
Time frame: Baseline, post-test 12 weeks
Timed Up and Go (TUG)
Time frame: Baseline, post-test 6 weeks
GAITRite® system
Time frame: Baseline, post-test 12 weeks
GAITRite® system
Time frame: Baseline, post-test 6 weeks
The short International Physical Activity Questionnaire
Time frame: Baseline, post-test 12 weeks
The short International Physical Activity Questionnaire
Time frame: Baseline, post-test 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: Undecided. check
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larissa Donatoni da Silva, Phd student principal investigator
National University of Ireland, Galway, Ireland
Questions about this trial
What is this clinical trial studying?
A study testing Pilates and exercise without Pilates in people with Healthy, run by National University of Ireland, Galway, Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls Efficacy Scale (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.