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Clinical Trials/NCT01919645
NCT01919645
Completed
Not Applicable

Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality in Women With Rheumatoid Arthritis: A Randomized Clinical Trial Study

Federal University of São Paulo1 site in 1 country43 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthritis, Rheumatoid
Sponsor
Federal University of São Paulo
Enrollment
43
Locations
1
Primary Endpoint
Improvement of sleep through a polysomnogram exam.
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Physical exercise programs are effective and safe for the improvement of the sleep efficiency in patients with Rheumatoid Arthritis.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
December 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Andrea Kayo

PhD Student

Federal University of São Paulo

Eligibility Criteria

Inclusion Criteria

  • Women ages 35-65 years diagnosed with Rheumatoid Arthritis according with the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR)Criteria; Pittsburgh Sleep Quality Index ≥ 5; electrocardiogram test (ECG) at rest and at regular effort.

Exclusion Criteria

  • Patients with joint restrictions due to disease.
  • Other rheumatoid-associated diseases (Fibromyalgia) with the exception of Osteoarthritis of low degree.
  • Those who are uncontrollably hypertense, diabetic, with thyroidopathy and cardiorespiratory diseases which stop them from practicing exercises.
  • Class II obesity (IMC ≥ 35 Kg/m2).
  • Cognitive deficits.
  • Depression.
  • Patients not following the study rules such as exercise hours and / or time for the proposed program.
  • Current physical exercise practitioner.
  • Those undergoing medication treatment which would interfere sleep.
  • Night shift workers who disrespect regular working schedule.

Outcomes

Primary Outcomes

Improvement of sleep through a polysomnogram exam.

Time Frame: at baseline and at end-week 16

Evaluation of N3 stage of the sleep through a polysomnogram before and after 16 weeks of supervised exercises.

Study Sites (1)

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