Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus.
NCT ID: NCT02037971
Last Updated: 2014-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2013-02-28
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Aerobic Exercise
Subjects will follow one defined exercise process, according their cardiopulmonary exercise test, during 16 weeks, two times per a week.
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.
Control Group
A non-exercise group will receive regular educational information relating to their condition.
Control Group
The control group will have monthly meetings to learn about: good sleep habits, Systemic Lupus Erythematosus (their disease) and general good health.
Interventions
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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.
Control Group
The control group will have monthly meetings to learn about: good sleep habits, Systemic Lupus Erythematosus (their disease) and general good health.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pittsburgh sleep quality index (PSQI) ≥ 5;
* Free and Clarified Consent Term signature.
Exclusion Criteria
* 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);
18 Years
69 Years
FEMALE
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Lilian K C Reis, Principal Investigator
Principal Investigator
Principal Investigators
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Lilian KC Reis
Role: STUDY_CHAIR
Federal University of São Paulo UNIFESP
Virginia FM Trevisani
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
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Psychobiology and Exercise Studies Centre
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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03315312.8.0000.5505
Identifier Type: -
Identifier Source: org_study_id
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