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Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus. (EFEXO)

Primary Purpose

Systemic Lupus Erythematosus, Sleep Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic Exercise
Control Group
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, Lupus, Sleep disorders, Sleep disturbed, Physical exercise, Aerobic exercise

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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);

Sites / Locations

  • Psychobiology and Exercise Studies CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aerobic Exercise

Control Group

Arm Description

Subjects will follow one defined exercise process, according their cardiopulmonary exercise test, during 16 weeks, two times per a week.

A non-exercise group will receive regular educational information relating to their condition.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Quality of life assessment
Subjects' health will be evaluated utilizing the questionnaire 'Short Form (36) Health Survey' (SF-36).
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.
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.
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.

Full Information

First Posted
March 24, 2013
Last Updated
January 14, 2014
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02037971
Brief Title
Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus.
Acronym
EFEXO
Official Title
Effectiveness of Exercise Training in Improving Sleep in Patients With Systemic Lupus Erythematosus: A Controlled Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Sleep Disorders
Keywords
Systemic Lupus Erythematosus, Lupus, Sleep disorders, Sleep disturbed, Physical exercise, Aerobic exercise

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
Subjects will follow one defined exercise process, according their cardiopulmonary exercise test, during 16 weeks, two times per a week.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
A non-exercise group will receive regular educational information relating to their condition.
Intervention Type
Procedure
Intervention Name(s)
Aerobic Exercise
Other Intervention Name(s)
Physical activity, Physical training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
The control group will have monthly meetings to learn about: good sleep habits, Systemic Lupus Erythematosus (their disease) and general good health.
Primary Outcome Measure Information:
Title
Sleep Efficiency
Description
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.
Time Frame
16 weeks
Title
Sleep quality
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Pain assessment
Description
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.
Time Frame
16 weeks
Title
Disease activity assessment
Description
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.
Time Frame
16 weeks
Title
Quality of life assessment
Description
Subjects' health will be evaluated utilizing the questionnaire 'Short Form (36) Health Survey' (SF-36).
Time Frame
16 weeks
Title
Restless Legs Syndrome gravity assessment
Description
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.
Time Frame
16 weeks
Title
Fatigue assessment
Description
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.
Time Frame
16 weeks
Title
Fatigue assessment
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LILIAN REIS
Phone
+55 1193869111
Email
lilian.reis2004@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilian KC Reis
Organizational Affiliation
Federal University of São Paulo UNIFESP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Virginia FM Trevisani
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychobiology and Exercise Studies Centre
City
São Paulo
State/Province
SP
ZIP/Postal Code
04020-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lílian Reis
Phone
+55 11 993869111
Email
lilian.reis2004@terra.com.br
First Name & Middle Initial & Last Name & Degree
Lílian Reis

12. IPD Sharing Statement

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Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus.

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