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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
Sponsor:
Information provided by (Responsible Party):
Lilian K C Reis, Principal Investigator, Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE March 24, 2013
First Posted Date  ICMJE January 16, 2014
Last Update Posted Date January 16, 2014
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus.
Official Title  ICMJE Effectiveness of Exercise Training in Improving Sleep in Patients With Systemic Lupus Erythematosus: A Controlled Randomized Trial.
Brief Summary The purpose of this study is to determine the effectiveness of exercise training on improving sleep in patients with systemic lupus erythematosus.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Systemic Lupus Erythematosus
  • Sleep Disorders
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Aerobic Exercise
    Subjects will follow one defined exercise process, according their cardiopulmonary exercise test, during 16 weeks, two times per a week.
    Intervention: Procedure: Aerobic Exercise
  • Experimental: Control Group
    A non-exercise group will receive regular educational information relating to their condition.
    Intervention: Other: Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 14, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2015
Estimated Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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);
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02037971
Other Study ID Numbers  ICMJE 03315312.8.0000.5505
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Lilian K C Reis, Principal Investigator, Federal University of São Paulo
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Federal University of São Paulo
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lilian KC Reis Federal University of São Paulo UNIFESP
Principal Investigator: Virginia FM Trevisani Federal University of São Paulo
PRS Account Federal University of São Paulo
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP