Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality. Regarding Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Physical exercise programs are effective and safe for the improvement of the sleep efficiency in patients with Rheumatoid Arthritis.

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

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Other: Combined Training ( Strength + Aerobics)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined Training Group<br>Combined Training - (strength + aerobics). A combined training (CT)is performed, having aerobics exercises (AE)using a stationary bicycle and strength training in workout devices. The strength training (ST) will be performed by isotonic exercises recruiting the main muscle groups. They exercises are: Chest Press, Leg Press, Vertical Traction, Leg Extension and Abdominal Crunch. | Other: Combined Training ( Strength + Aerobics)<br>* Strength training performed using workout devices and aerobic training performed using stationary bicycle.<br>|
| Placebo Comparator: Control Group<br>The control group patients did not perform any intervention through physical exercises. They were oriented on Sleep Hygiene and were followed during the study. They were asked to come to the following visits (at weeks 8 and 16) and to 2 additional visits to get and then return the actigraph. During this period, they were followed through phone calls once a month and were asked for sleep hygiene and were reminded of their assessment dates. | Other: Combined Training ( Strength + Aerobics)<br>* Strength training performed using workout devices and aerobic training performed using stationary bicycle.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of sleep through a polysomnogram exam. | Evaluation of N3 stage of the sleep through a polysomnogram before and after 16 weeks of supervised exercises. | at baseline and at end-week 16 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, Sleep Disorders, Polysomnography, Sleep Stages, Physical Exercise