Systemic Lupus ErythematosusEFEXONCT02037971
Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus.
A study testing Aerobic Exercise in people with Systemic Lupus Erythematosus and Sleep Disorders, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the effectiveness of exercise training on improving sleep in patients with systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus, Sleep Disorders
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Psychobiology and Exercise Studies Centre
São Paulo, São Paulo, 04020-050
Lílian Reis, +55 11 993869111, lilian.reis2004@terra.com.br
Lílian Reis
About this study
Official title: Effectiveness of Exercise Training in Improving Sleep in Patients With Systemic Lupus Erythematosus: A Controlled Randomized Trial.
The purpose of this study is to determine the effectiveness of exercise training on improving sleep in patients with systemic lupus erythematosus.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus, Sleep Disorders
- Being tested
- Aerobic Exercise, Control Group
- Keywords
- Systemic Lupus Erythematosus, Lupus, Sleep disorders, Sleep disturbed, Physical exercise, Aerobic exercise
- Medical subject headings
- Lupus Erythematosus, Systemic, Sleep Wake Disorders, Parasomnias, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseProcedure or surgery
Also called Physical activity, Physical training
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 GroupOther
The control group will have monthly meetings to learn about: good sleep habits, Systemic Lupus Erythematosus (their disease) and general good health.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Subjects will follow one defined exercise process, according their cardiopulmonary exercise test, during 16 weeks, two times per a week. Receives: Procedure: Aerobic Exercise |
| Control Group | Experimental | A non-exercise group will receive regular educational information relating to their condition. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
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.
Measured: 16 weeks
Sleep quality
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.
Measured: 16 weeks
Secondary outcomes (6)
Pain assessment
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.
Measured: 16 weeks
Disease activity assessment
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.
Measured: 16 weeks
Quality of life assessment
Subjects' health will be evaluated utilizing the questionnaire 'Short Form (36) Health Survey' (SF-36).
Measured: 16 weeks
Restless Legs Syndrome gravity assessment
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.
Measured: 16 weeks
Fatigue assessment
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.
Measured: 16 weeks
Fatigue assessment
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilian K C Reis, Principal Investigator, Federal University of São Paulo
- Investigators
- Lilian KC Reis, Study chair, Federal University of São PauloVirginia FM Trevisani, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037971
- Sponsor's protocol ID
- 03315312.8.0000.5505
- Acronym
- EFEXO
- Status last verified
- May 2013
- First submitted
- 24 Mar 2013
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercise Training in Improving Sleep in Patients With Systemic Lupus Erythematosus: A Controlled Randomized Trial.
- ClinicalTrials.gov ID
- NCT02037971
- Acronym / sponsor ID
- EFEXO / 03315312.8.0000.5505
- Conditions
- Systemic Lupus Erythematosus, Sleep Disorders
- Keywords
- Systemic Lupus Erythematosus, Lupus, Sleep disorders, Sleep disturbed, Physical exercise, Aerobic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Procedure: Aerobic ExerciseSubjects will follow one defined exercise process, according their cardiopulmonary exercise test, during 16 weeks, two times per a week. |
| Control Group | Experimental | Other: Control GroupA non-exercise group will receive regular educational information relating to their condition. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseAlso: Physical activity, Physical trainingFrom 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. | Procedure or surgery | Aerobic Exercise |
| Control GroupThe control group will have monthly meetings to learn about: good sleep habits, Systemic Lupus Erythematosus (their disease) and general good health. | Other | Control Group |
Primary outcome
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.
6 secondary outcomes
Pain assessment
Time frame: 16 weeks
Disease activity assessment
Time frame: 16 weeks
Quality of life assessment
Time frame: 16 weeks
Restless Legs Syndrome gravity assessment
Time frame: 16 weeks
Fatigue assessment
Time frame: 16 weeks
Fatigue assessment
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilian KC Reis study chair
Federal University of São Paulo
Virginia FM Trevisani principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Systemic Lupus Erythematosus and Sleep Disorders, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LILIAN REIS (+55 1193869111, lilian.reis2004@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2014.