Systemic Lupus Erythematosus Clinical Trial
— EFEXOOfficial title:
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.
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); |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Brazil | Psychobiology and Exercise Studies Centre | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
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 |
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