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

Effectiveness of Exercise Training in Improving Sleep in Patients With Systemic Lupus Erythematosus: A Controlled Randomized Trial.

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

Study Overview

• Status: Unknown
• Conditions: Systemic Lupus Erythematosus; Sleep Disorders
• Intervention / Treatment: Procedure: Aerobic Exercise; Other: Control Group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04020-050
      • Recruiting
      • Psychobiology and Exercise Studies Centre
      • Contact: Lílian Reis; Phone Number: +55 11 993869111; Email: lilian.reis2004@terra.com.br
      • Principal Investigator: Lílian Reis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic Exercise; Subjects will follow one defined exercise process, according their cardiopulmonary exercise test, during 16 weeks, two times per a week.	Procedure: Aerobic Exercise; From 1st week up to and including 4th week, subjects will do: 5 minutes warm-up, then 15-30 minutes low to moderate (55-65% VO2) exercise, then 15 minutes stretching. From 5th week up to and including 16th week, subjects will do: 5 minutes warm-up, then intermittent training for between 30-40 minutes, then 10 minutes stretching.; Other Names: Physical activity; Physical training
Experimental: Control Group; A non-exercise group will receive regular educational information relating to their condition.	Other: Control Group; The control group will have monthly meetings to learn about: good sleep habits, Systemic Lupus Erythematosus (their disease) and general good health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Efficiency	Sleep efficiency will be evaluate with actigraph. The subject will use it for 15 days before the period of exercise, 15 days at the start of the period of exercise, and then 15 last days in the period of exercise. Complementing the information collected by the device, the patient will complete a sleep diary, with schedules of activities such as: time they go to bed, time they fall asleep, time they get up, times they remove the device (which is not waterproof), times they replace the device, and times they wake up from naps.	16 weeks
Sleep quality	The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire that includes 21 items that assess the quality of sleep during a one-month period. The subject will be asked it, before, during and after the period of exercise. The questionnaire is divided into seven components: subjective sleep quality, sleep latency, sleep duration, sleep effectiveness, sleep disorder, use of sleep medication, and daytime dysfunction. On the PSQI a score ≥ 5 indicates poor quality of sleep, and ≤ 4 indicates good quality of sleep.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	Subjects' pain will be assessed utilizing the Visual Analogue Scale (VAS) which consists of a numeric range from 1 to 10, where 1 represents light pain and 10 represents intense pain.	16 weeks
Disease activity assessment	Subjects' disease activity will be evaluated using SLEDAI, a modification of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). It is a list of 24 clinical and laboratory items which assess and quantify disease activity. A subject's score has to be ≤ 8 to be considered for the study.	16 weeks
Quality of life assessment	Subjects' health will be evaluated utilizing the questionnaire 'Short Form (36) Health Survey' (SF-36).	16 weeks
Restless Legs Syndrome gravity assessment	Subjects' Restless Legs Syndrome (RLS) gravity will be assessed using the International Restless Legs Syndrome Rating Scale. It consists in 10 questions that evaluate the severity of symptoms and impact of the disease on daily life activities.	16 weeks
Fatigue assessment	Subjects' fatigue will be evaluated using the Fatigue Severity Scale (FSS) which consists of 9 questions and a numeric range from 1 to 7, where 1 represents minimum severity and 7 represents maximum severity.	16 weeks
Fatigue assessment	Subjects' fatigue will be evaluated using the Visual Analogue Scale for overall fatigue (VAS-fatigue) which consists of a numeric range from 1 to 10, where 1 represents light fatigue and 10 represents intense fatigue.	16 weeks

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Study Chair: Lilian KC Reis, Federal University of São Paulo UNIFESP; Principal Investigator: Virginia FM Trevisani, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: March 24, 2013
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Estimate): January 16, 2014
• Last Update Submitted That Met QC Criteria: January 14, 2014
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Lupus; Aerobic exercise; Sleep disorders; Systemic Lupus Erythematosus; Sleep disturbed; Physical exercise
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Neurologic Manifestations; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: 03315312.8.0000.5505

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No