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Status unknownNCT03321084Updated Feb 5, 2018

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

An interventional study of MatPliates and Control in Osteoarthritis, Knee, sponsored by Maria das Graças Rodrigues de Araújo. Status unknown at 1 site in Brazil. Open to female participants aged 60 Years to 69 Years. Per ClinicalTrials.gov, last updated 2018-02-05.

Sponsored by Maria das Graças Rodrigues de Araújo · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
60 Years to 69 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Osteoarthritis, Knee

Keywords

  • Osteoarthrosis
  • Exercise Movement Techniques
  • Pilates
  • Elderly
  • Physiotherapy
03

Who can participate

Ages eligible
60 Years to 69 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Change in habitual drug's program during the study
  • Join in other physical activity during the study
  • Refuse to wear suitable clothing
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • 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.

    Other: MatPliates

  • Other
    Control

    It continues in your daily life with phone monitoring.

    Other: Control

Interventions

  • OtherMatPliates

    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.

    Also known as: Experimental

  • OtherControl

    Will not be submitted to any physical intervention. It continues in your daily life with only phone monitoring.

05

What researchers measure

Primary outcomes

  1. Pain.

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

    Time frame: 7 weeks.

Secondary outcomes

  1. Pain

    Visual analog scale.

    Time frame: 7 weeks.

  2. Pain

    Lequesne Index.

    Time frame: 7 weeks.

  3. Functionality.

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

    Time frame: 7 weeks.

  4. Functionality.

    Lequesne Index.

    Time frame: 7 weeks.

  5. Stiffness.

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

    Time frame: 7 weeks.

  6. Balance.

    Timed and Up Go Test (TUG)

    Time frame: 7 weeks.

06

Study locations

1 of 1 sites recruiting
  • Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)
    Recife, Pernambuco 50670-901, Brazil
    Recruiting
07

Registry details

Key details

Study ID
NCT03321084
Lead sponsor
Maria das Graças Rodrigues de Araújo
Responsible party
Maria das Graças Rodrigues de Araújo (PhD, Universidade Federal de Pernambuco) — Sponsor-investigator
First posted
Oct 25, 2017
Start date
Apr 20, 2017
Primary completion
Apr 20, 2017
Completion
Mar 20, 2018 (estimated)
Last update
Feb 5, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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