Clinical trial NCT02037971: Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus.
Official title: Effectiveness of Exercise Training in Improving Sleep in Patients With Systemic Lupus Erythematosus: A Controlled Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
Sleep Disorders
Keywords: Systemic Lupus Erythematosus
Lupus
Sleep disorders
Sleep disturbed
Physical exercise
Aerobic exercise
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine the effectiveness of exercise training on improving sleep in patients with systemic lupus erythematosus.

Detailed description: This study will test the effectiveness of aerobic exercise on improving sleep in patients with systemic lupus erythematosus. The subjects will do treadmill 2 times per week, from 15-20 min. with low to moderate(55-65% maxCF) intensity exercise, so 30 min. until 4ª week. From the 5ª to 8ª week they will be able to make greater efforts to 35-40 min. totalizing 16 weeks. The control group will not do exercise and will receive education class about disease, health, sleep, 1 time per month.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Systemic Lupus Erythematosus (SLE) according American College of Rheumatology (ACR) Criteria revised in 1997;
* Pittsburgh sleep quality index (PSQI) ≥ 5;
* Free and Clarified Consent Term signature.

Exclusion Criteria:

* Patients who have other rheumatologic diseases (rheumatoid arthritis, sjogren syndrome, fibromyalgia, ankylosis spondylitis), excerpt mild osteoarthritis;
* Systemic Lupus Erythematosus Disease Assessment Index (SLEDAI) \> 8;
* Untreated diseases: Hypertension, diabetes mellitus (DM), dyslipidemia, thyroid dysfunction, cardiorespiratory diseases, malignancies;
* Patients who do not accept the study rules as time and/or follow-up exercise program time proposed;
* Suspected or pregnancy confirmation;

  \* Patients who are taking sleeping medication;
* Patients who won´t sign the Free and Clarified Consent Term informed;
* Patients engaged in physical activity (defined as previously sedentary individuals, or that which do not perform any type of regular physical activity at least six months);

Primary outcomes:
measure: Sleep Efficiency
timeFrame: 16 weeks
measure: Sleep quality
timeFrame: 16 weeks
Secondary outcomes:
measure: Pain assessment
timeFrame: 16 weeks
measure: Disease activity assessment
timeFrame: 16 weeks
measure: Quality of life assessment
timeFrame: 16 weeks
measure: Restless Legs Syndrome gravity assessment
timeFrame: 16 weeks
measure: Fatigue assessment
timeFrame: 16 weeks
measure: Fatigue assessment
timeFrame: 16 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Psychobiology and Exercise Studies Centre
state: SP
Study officials:
affiliation: Federal University of São Paulo UNIFESP
name: Lilian KC Reis
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Virginia FM Trevisani
role: PRINCIPAL_INVESTIGATOR
References: