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Effects of MatPilates in Pain and Functionality in Elderly Woman With Osteoarthritis.

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
MatPliates
Control
Sponsored by
Maria das Graças Rodrigues de Araújo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthrosis, Exercise Movement Techniques, Pilates, Elderly, Physiotherapy

Eligibility Criteria

60 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

MatPilates

Control

Arm Description

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.

It continues in your daily life with phone monitoring.

Outcomes

Primary Outcome Measures

Pain.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Secondary Outcome Measures

Pain
Visual analog scale.
Pain
Lequesne Index.
Functionality.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Functionality.
Lequesne Index.
Stiffness.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Balance.
Timed and Up Go Test (TUG)

Full Information

First Posted
September 14, 2017
Last Updated
February 1, 2018
Sponsor
Maria das Graças Rodrigues de Araújo
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1. Study Identification

Unique Protocol Identification Number
NCT03321084
Brief Title
Effects of MatPilates in Pain and Functionality in Elderly Woman With Osteoarthritis.
Official Title
Effects of MatPilates in Pain and Functionality in Elderly Woman With Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
March 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maria das Graças Rodrigues de Araújo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthrosis, Exercise Movement Techniques, Pilates, Elderly, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: a MatPilates group (MG) and a Control group (CG).
Masking
InvestigatorOutcomes Assessor
Masking Description
The one who assess the patients in the beginning and in the final moment (investigator) not know in what group the patient is. As the investigator that will do the statistic (outcome assessor).
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MatPilates
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
It continues in your daily life with phone monitoring.
Intervention Type
Other
Intervention Name(s)
MatPliates
Other Intervention Name(s)
Experimental
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Will not be submitted to any physical intervention. It continues in your daily life with only phone monitoring.
Primary Outcome Measure Information:
Title
Pain.
Description
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Time Frame
7 weeks.
Secondary Outcome Measure Information:
Title
Pain
Description
Visual analog scale.
Time Frame
7 weeks.
Title
Pain
Description
Lequesne Index.
Time Frame
7 weeks.
Title
Functionality.
Description
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Time Frame
7 weeks.
Title
Functionality.
Description
Lequesne Index.
Time Frame
7 weeks.
Title
Stiffness.
Description
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Time Frame
7 weeks.
Title
Balance.
Description
Timed and Up Go Test (TUG)
Time Frame
7 weeks.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria das Graças Araujo, PhD
Phone
+558121268939
Email
mgrodriguesaraujo@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Effects of MatPilates in Pain and Functionality in Elderly Woman With Osteoarthritis.

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