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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

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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Sleep Disorders Procedure: Aerobic Exercise Other: Control Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Quality of life assessment [ Time Frame: 16 weeks ]
    Subjects' health will be evaluated utilizing the questionnaire 'Short Form (36) Health Survey' (SF-36).

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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);

Information from the National Library of Medicine

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


Contacts
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Contact: LILIAN REIS +55 1193869111 lilian.reis2004@terra.com.br

Locations
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Brazil
Psychobiology and Exercise Studies Centre Recruiting
São Paulo, SP, Brazil, 04020-050
Contact: Lílian Reis    +55 11 993869111    lilian.reis2004@terra.com.br   
Principal Investigator: Lílian Reis         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Study Chair: Lilian KC Reis Federal University of São Paulo UNIFESP
Principal Investigator: Virginia FM Trevisani Federal University of São Paulo
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Responsible Party: Lilian K C Reis, Principal Investigator, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02037971    
Other Study ID Numbers: 03315312.8.0000.5505
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: May 2013
Keywords provided by Lilian K C Reis, Principal Investigator, Federal University of São Paulo:
Systemic Lupus Erythematosus
Lupus
Sleep disorders
Sleep disturbed
Physical exercise
Aerobic exercise
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Nervous System Diseases
Neurologic Manifestations
Mental Disorders