Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus.

Systemic Lupus Erythematosus Clinical Trial

— EFEXO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02037971
• Other study ID #: 03315312.8.0000.5505
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2013
• Last updated: January 14, 2014
• Start date: February 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2013
• Source: Federal University of São Paulo
• Contact: LILIAN REIS
• Phone: +55 1193869111
• Email: lilian.reis2004[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Parasomnias
• Sleep Disorders
• Systemic Lupus Erythematosus

Intervention

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:
• Control Group
The control group will have monthly meetings to learn about: good sleep habits, Systemic Lupus Erythematosus (their disease) and general good health.

Locations

Country	Name	City	State
Brazil	Psychobiology and Exercise Studies Centre	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Quality of life assessment	Subjects' health will be evaluated utilizing the questionnaire 'Short Form (36) Health Survey' (SF-36).	16 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes