Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus. (EFEXO)

Federal University of São Paulo

Status: Unknown

Conditions: Sleep Disorders; Systemic Lupus Erythematosus

Treatments: Other: Control Group; Procedure: Aerobic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02037971

03315312.8.0000.5505

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Aerobic Exercise

Experimental group

Description:

Subjects will follow one defined exercise process, according their cardiopulmonary exercise test, during 16 weeks, two times per a week.

Treatment:

Procedure: Aerobic Exercise

Control Group

Experimental group

Description:

A non-exercise group will receive regular educational information relating to their condition.

Treatment:

Other: Control Group