- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321084
Effects of MatPilates in Pain and Functionality in Elderly Woman With Osteoarthritis.
Introduction: The osteoarthrosis is incurable, one of the most incapacitating disease around the world and your prevalence is increasing every year. The main consequences of this disease is pain and loss of functionality as a result of biomechanical limitations coming from articular inflammation. Among the variability of therapeutic resources, we propose MatPilates like a no drug intervention, that probably will contribute for a decrease in the symptoms of this disease.
Objective: It is hypothesized that MatPilates is a method capable of decrease pain and increase functionality in elderly woman with osteoarthrosis.
Methods: This study is a randomized double blind clinical trial, in which the volunteer need be in between 60 and 69 years old. Will be formed of two groups: MatPilates Group (MG) and Control Group (CG), and the ideal "n" will be calculated in a pilot study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pernambuco
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Recife, Pernambuco, Brazil, 50670-901
- Recruiting
- Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Bilateral osteoarthritis
- Body mass index (BMI) between 25 and 34,9 (WHO, 2000)
- Mini mental state examination score, with cutoff score of 18 (illiterate) and 24 (literate) (BRUCKI et al. 2003; LOURENÇO e VERAS, 2006)
- Unassisted gait (no wheelchair, no walking stick, no crutches or no walker)
- No history of neurologic disease
- No other physical activity
- Never practiced Pilates
Exclusion Criteria:
- Change in habitual drug's program during the study
- Join in other physical activity during the study
- Refuse to wear suitable clothing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MatPilates
In the beginning was nominated Contrology, but today is known as Pilates.
Created by Joseph Humbertus Pilates.
This technique is based on respiration, balance, flexibility, proprioception and muscular strength.
One of the main work is on the power house (core), biomechanical axis of the body, composed of muscles: rectus abdominis, paravertebral, multifidus, diaphragm, and those of the perineal center.
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The MatPilates program was specialized developed for this trial, in which all exercises belong to contemporaneous Pilates style.
Each session has 60 minutes of duration, divided in three blocs (stretching, exercise and relaxation), with mean of 10, 40 and 10 minutes respectively (VIEIRA et al., 2016).
Each exercise will be performed in one series of 10 to 15 repetitions and will be modified accordingly the patient need.
Other Names:
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Other: Control
It continues in your daily life with phone monitoring.
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Will not be submitted to any physical intervention.
It continues in your daily life with only phone monitoring.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain.
Time Frame: 7 weeks.
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
|
7 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: 7 weeks.
|
Visual analog scale.
|
7 weeks.
|
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Pain
Time Frame: 7 weeks.
|
Lequesne Index.
|
7 weeks.
|
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Functionality.
Time Frame: 7 weeks.
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
|
7 weeks.
|
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Functionality.
Time Frame: 7 weeks.
|
Lequesne Index.
|
7 weeks.
|
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Stiffness.
Time Frame: 7 weeks.
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
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7 weeks.
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Balance.
Time Frame: 7 weeks.
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Timed and Up Go Test (TUG)
|
7 weeks.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- MatPilates and Ostheoarthritis
- Feedback N. 2.019.484 (Other Identifier: UFPE CAAE N. 63530416.1.0000.5208)
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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