NCT03321084

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2018

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

Same day

First QC Date

September 14, 2017

Last Update Submit

February 1, 2018

Conditions

Osteoarthritis, Knee

Keywords

OsteoarthrosisExercise Movement TechniquesPilatesElderlyPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Pain.

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

    7 weeks.

Secondary Outcomes (6)

  • Pain

    7 weeks.

  • Pain

    7 weeks.

  • Functionality.

    7 weeks.

  • Functionality.

    7 weeks.

  • Stiffness.

    7 weeks.

  • +1 more secondary outcomes

Study Arms (2)

MatPilates

EXPERIMENTAL

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

Control

OTHER

It continues in your daily life with phone monitoring.

Other: Control

Interventions

MatPliatesOTHER

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
MatPilates
ControlOTHER

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

Control

Eligibility Criteria

Age60 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Recife, Pernambuco, 50670-901, Brazil

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups: a MatPilates group (MG) and a Control group (CG).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 14, 2017

First Posted

October 25, 2017

Study Start

April 20, 2017

Primary Completion

April 20, 2017

Study Completion

March 20, 2018

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

BR(1)