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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03321084
Other study ID # MatPilates and Ostheoarthritis
Secondary ID Feedback N. 2.01
Status Recruiting
Phase N/A
First received September 14, 2017
Last updated February 1, 2018
Start date April 20, 2017
Est. completion date March 20, 2018

Study information

Verified date February 2018
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date March 20, 2018
Est. primary completion date April 20, 2017
Accepts healthy volunteers No
Gender Female
Age group 60 Years to 69 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE) Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Maria das Graças Rodrigues de Araújo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). 7 weeks.
Secondary Pain Visual analog scale. 7 weeks.
Secondary Pain Lequesne Index. 7 weeks.
Secondary Functionality. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). 7 weeks.
Secondary Functionality. Lequesne Index. 7 weeks.
Secondary Stiffness. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). 7 weeks.
Secondary Balance. Timed and Up Go Test (TUG) 7 weeks.
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