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

F

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

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

Trial contacts and locations

1

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Central trial contact

LILIAN REIS

Data sourced from clinicaltrials.gov

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