- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03526757
Effects of Pilates Standing Exercises on Walking Mobility and Postural Balance
The Effects of Pilates Standing Exercises on Walking Mobility and Postural Balance in Sedentary Older Adults: a Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Importance: Aging is characterized by numerous molecular, physiological, functional, motor and psychological changes, such as loss of postural balance and reduced muscle mass/strength. Such modifications often lead to reduced physical-functional capacity in the elderly and increased risk of falls. Currently, physical exercise is widely used to improve physical performance and reduce, at least in part, postural instabilities and the risk of falls. In this context, the Pilates method may be a good strategy to improve body balance, muscle strength and, potentially, the perception of quality of life in this population, depending how the exercises are performed.
Objective: To evaluate whether practicing Pilates exercises in orthostatic position results in differential effects on walking mobility and postural balance in healthy elderly women when compared to the standard sequence in the Pilates method, which involves less time performing exercise in the orthostatic position.
Design, Methods and Participants: Clinical, single blind controlled and randomized trial. 36 previously sedentary elderly women will be included in the study and sign a Free and Informed Consent Term (TCLE). The Pilates protocols will be administered over 12 weeks on a bi-weekly scheme, and each session will last approximately 50 minutes. The subjects who agree to participate will be evaluated at baseline and immediately post-intervention.
Intervention: Subjects will be randomized to participate in the experimental group (Pilates exercises with emphasis on orthostatic posture) or control group (Pilates exercises practiced following traditional sequence of postures).
Main Outcomes and Measurements: The main outcome of the study will be walking mobility and postural balance, assessed using the Timed Up and Go test (single "motor" and dual task "cognitive-motor" tests), BERG Balance Scale, Functional Reach Test, and ABC Balance Confidence Scale).
Expected results: The experimental group is expected to perform better in terms of walking mobility and body balance, since hypothetically, a higher relative volume of orthostatic exercises would be more adequate for training anticipatory postural adjustments when compared to the traditional Pilates postural sequence.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90619-900
- Pontificia Universidade Católica do Rio Grande do Sul
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sedentary for at least 6 months
- To be available for one hour, twice a week, on two different working days to perform the proposed exercises.
- To show preserved cognitive function, according to the mini-mental state examination criteria;
- Be able to come and go on their own to the training location (Physiotherapy Laboratory at PUCRS).
Exclusion Criteria:
- Clinical contraindications for performing physical exercises;
- To show severe heart, orthopedic, neurological or other diseases/conditions that may affect the outcome measures;
- Practicing physical exercises outside the study protocol;
- Absence of independent gait.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Standing Pilates protocol
Subjects will be submitted to a bi-weekly, 50-minute session of Pilates exercises focusing on orthostatic position, for twelve weeks.
The following equipment will be used: The Cadillac, Reformer and Chair, emphasizing balance training in the orthostatic position.
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Subjects will be submitted to a bi-weekly, 50-minute session of Pilates exercises focusing on orthostatic position, for twelve weeks.
The following equipment will be used: The Cadillac, Reformer and Chair, emphasizing balance training in the orthostatic position.
Other Names:
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ACTIVE_COMPARATOR: Standard Pilates protocol
Subjects will be submitted to a bi-weekly, 50-minute session of the standard sequence of Pilates exercises (traditional sequence of the contemporary / classical method) for twelve weeks.
The exercises will be performed using the same equipment used in the intervention group, but following the dorsal decubitus, sedestation and orthostasis, in a time-balanced distribution in each session.
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Subjects will be submitted to a bi-weekly, 50-minute session of the standard sequence of Pilates exercises (traditional sequence of the contemporary / classical method) for twelve weeks.
The exercises will be performed using the same equipment used in the intervention group, but following the dorsal decubitus, sedestation and orthostasis, in a time-balanced distribution in each session.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking mobility (Timed Up and Go Test)
Time Frame: Post-intervention (change after 12 weeks of training)
|
Walking mobility will be assessed using the Timed Up and Go tests (single and dual task - cognitive/motor).
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.
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Post-intervention (change after 12 weeks of training)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postural balance - Functional Reach Test
Time Frame: Post-intervention (change after 12 weeks of training)
|
Postural balance will be assessed using the Functional Reach Test.
The FRT is a quick single-task dynamic test defined as the maximal distance one can reach forward beyond arm's length, while maintaining a fixed base of support in the standing position.
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Post-intervention (change after 12 weeks of training)
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Postural balance - BERG Balance scale
Time Frame: Post-intervention (change after 12 weeks of training)
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The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
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Post-intervention (change after 12 weeks of training)
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Activities-specific Balance Confidence (ABC) Scale.
Time Frame: Post-intervention (change after 12 weeks of training)
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For each assessed activity, the subjects indicate their level of confidence in doing the activity without losing your balance or becoming unsteady from choosing one of the percentage points on the scale from 0% to 100%.
If subjects do not currently do the activity in question, they should imagine how confident they would be if had to do the activity.
If they normally use a walking aid to do the activity or hold onto someone, subjects should rate their confidence as if they were using these supports.
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Post-intervention (change after 12 weeks of training)
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Quality of life (36-Item Short Form Health Survey - SF-36)
Time Frame: Post-intervention (change after 12 weeks of training)
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Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).
The SF-36 consists of eight scaled scores (vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; and mental health.),
which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
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Post-intervention (change after 12 weeks of training)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity Levels
Time Frame: Baseline
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Physical Activity Levels will be assessed using the International Physical Activity Questionnaire (IPAQ).
The International Physical Activity Questionnaire (IPAQ) estimates the weekly energy expenditure for physical activities (PA).
This instrument was validated for use with Brazilian older adults.
The report of the IPAQ adapted for older adults should be delivered in minutes per week.
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Baseline
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Cognition screening
Time Frame: Baseline
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Cognitive decline will be screened using the Mini Mental State Examination (MMSE).
The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.
Any score greater than or equal to 24 points (out of 30) indicates a normal cognition.
Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
The raw score may also need to be corrected for educational attainment and age.
That is, a maximal score of 30 points can never rule out dementia.
Low to very low scores correlate closely with the presence of dementia, although other mental disorders can also lead to abnormal findings on MMSE testing.
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Baseline
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Depression screening
Time Frame: Baseline
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Depression will be screened using the Geriatric Depression Scale (GDS).
The scale consists of 30 yes/no questions.
Each question is scored as either 0 or 1 points.
The following general cutoff may be used to qualify the severity: 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".
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Baseline
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Régis G Mestriner, PhD, Pontificia Universidade Católica do Rio Grande do Sul
Publications and helpful links
General Publications
- Bird ML, Hill KD, Fell JW. A randomized controlled study investigating static and dynamic balance in older adults after training with Pilates. Arch Phys Med Rehabil. 2012 Jan;93(1):43-9. doi: 10.1016/j.apmr.2011.08.005. Epub 2011 Oct 5.
- Walowska J, Bolach B, Bolach E. The influence of Pilates exercises on body balance in the standing position of hearing impaired people. Disabil Rehabil. 2018 Dec;40(25):3061-3069. doi: 10.1080/09638288.2017.1370731. Epub 2017 Nov 13.
- Bueno de Souza RO, Marcon LF, Arruda ASF, Pontes Junior FL, Melo RC. Effects of Mat Pilates on Physical Functional Performance of Older Adults: A Meta-analysis of Randomized Controlled Trials. Am J Phys Med Rehabil. 2018 Jun;97(6):414-425. doi: 10.1097/PHM.0000000000000883.
- Oliveira LC, Oliveira RG, Pires-Oliveira DAA. Pilates increases the isokinetic muscular strength of the knee extensors and flexors in elderly women. J Bodyw Mov Ther. 2017 Oct;21(4):815-822. doi: 10.1016/j.jbmt.2017.01.006. Epub 2017 Jan 8.
- Bertoli J, Biduski GM, de la Rocha Freitas C. Six weeks of Mat Pilates training are enough to improve functional capacity in elderly women. J Bodyw Mov Ther. 2017 Oct;21(4):1003-1008. doi: 10.1016/j.jbmt.2016.12.001. Epub 2016 Dec 3.
- Teixeira de Carvalho F, de Andrade Mesquita LS, Pereira R, Neto OP, Amaro Zangaro R. Pilates and Proprioceptive Neuromuscular Facilitation Methods Induce Similar Strength Gains but Different Neuromuscular Adaptations in Elderly Women. Exp Aging Res. 2017 Oct-Dec;43(5):440-452. doi: 10.1080/0361073X.2017.1369624. Epub 2017 Sep 26.
- Vieira ND, Testa D, Ruas PC, Salvini TF, Catai AM, de Melo RC. The effects of 12 weeks Pilates-inspired exercise training on functional performance in older women: A randomized clinical trial. J Bodyw Mov Ther. 2017 Apr;21(2):251-258. doi: 10.1016/j.jbmt.2016.06.010. Epub 2016 Jun 21. Erratum In: J Bodyw Mov Ther. 2017 Jul;21(3):747.
- Greblo Jurakic Z, Krizanic V, Sarabon N, Markovic G. Effects of feedback-based balance and core resistance training vs. Pilates training on cognitive functions in older women with mild cognitive impairment: a pilot randomized controlled trial. Aging Clin Exp Res. 2017 Dec;29(6):1295-1298. doi: 10.1007/s40520-017-0740-9. Epub 2017 Mar 1.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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