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
ConditionsArthritis, Rheumatoid
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.
Investigators
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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