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History of Changes for Study: NCT02037971
Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus. (EFEXO)
Latest version (submitted January 14, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 14, 2014 None (earliest Version on record)
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Study NCT02037971
Submitted Date:  January 14, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 03315312.8.0000.5505
Brief Title: Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus. (EFEXO)
Official Title: Effectiveness of Exercise Training in Improving Sleep in Patients With Systemic Lupus Erythematosus: A Controlled Randomized Trial.
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2013
Overall Status: Unknown status [Previously: Recruiting]
Study Start: February 2013
Primary Completion: February 2014 [Anticipated]
Study Completion: March 2015 [Anticipated]
First Submitted: March 24, 2013
First Submitted that
Met QC Criteria:
January 14, 2014
First Posted: January 16, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 14, 2014
Last Update Posted: January 16, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Federal University of São Paulo
Responsible Party: Principal Investigator
Investigator: Lilian K C Reis, Principal Investigator
Official Title: Principal Investigator
Affiliation: Federal University of São Paulo
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Systemic Lupus Erythematosus
Sleep Disorders
Keywords: Systemic Lupus Erythematosus
Lupus
Sleep disorders
Sleep disturbed
Physical exercise
Aerobic exercise
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Health Services Research
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Control Group
The control group will have monthly meetings to learn about: good sleep habits, Systemic Lupus Erythematosus (their disease) and general good health.
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 69 Years
Sex: Female
Gender Based:
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);
Open or close this module Contacts/Locations
Study Officials: Lilian KC Reis
Study Chair
Federal University of São Paulo UNIFESP
Virginia FM Trevisani
Principal Investigator
Federal University of São Paulo
Locations: Brazil, SP
Psychobiology and Exercise Studies Centre
São Paulo, SP, Brazil, 04020-050
Contact:Contact: Lílian Reis +55 11 993869111 lilian.reis2004@terra.com.br
Contact:Principal Investigator: Lílian Reis
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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