Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus. (EFEXO)
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|ClinicalTrials.gov Identifier: NCT02037971|
Recruitment Status : Unknown
Verified May 2013 by Lilian K C Reis, Principal Investigator, Federal University of São Paulo.
Recruitment status was: Recruiting
First Posted : January 16, 2014
Last Update Posted : January 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus Sleep Disorders||Procedure: Aerobic Exercise Other: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effectiveness of Exercise Training in Improving Sleep in Patients With Systemic Lupus Erythematosus: A Controlled Randomized Trial.|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||March 2015|
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.
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.
- Sleep Efficiency [ Time Frame: 16 weeks ]
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.
- Sleep quality [ Time Frame: 16 weeks ]
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.
- Pain assessment [ Time Frame: 16 weeks ]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.
- Disease activity assessment [ Time Frame: 16 weeks ]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.
- Quality of life assessment [ Time Frame: 16 weeks ]Subjects' health will be evaluated utilizing the questionnaire 'Short Form (36) Health Survey' (SF-36).
- Restless Legs Syndrome gravity assessment [ Time Frame: 16 weeks ]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.
- Fatigue assessment [ Time Frame: 16 weeks ]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.
- Fatigue assessment [ Time Frame: 16 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037971
|Contact: LILIAN REIS||+55 firstname.lastname@example.org|
|Psychobiology and Exercise Studies Centre||Recruiting|
|São Paulo, SP, Brazil, 04020-050|
|Contact: Lílian Reis +55 11 993869111 email@example.com|
|Principal Investigator: Lílian Reis|
|Study Chair:||Lilian KC Reis||Federal University of São Paulo UNIFESP|
|Principal Investigator:||Virginia FM Trevisani||Federal University of São Paulo|