Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus.

NCT02037971 | Unknown DMC

• 1 other identifier: 03315312.8.0000.5505
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Lupus Erythematosus; Sleep Disorders

Keywords

Systemic Lupus Erythematosus; Lupus; Sleep disorders; Sleep disturbed; Physical exercise; Aerobic exercise

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  16 weeks

Secondary Outcomes (6)

• Pain assessment

  16 weeks

• Disease activity assessment

  16 weeks

• Quality of life assessment

  16 weeks

• Restless Legs Syndrome gravity assessment

  16 weeks

• Fatigue assessment

  16 weeks

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

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

Procedure: Aerobic Exercise

Control Group

EXPERIMENTAL

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

Other: Control Group

Interventions

Aerobic Exercise PROCEDURE

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.

Also known as: Physical activity, Physical training

Aerobic Exercise

Control Group OTHER

The control group will have monthly meetings to learn about: good sleep habits, Systemic Lupus Erythematosus (their disease) and general good health.

Control Group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Psychobiology and Exercise Studies Centre

São Paulo, São Paulo, 04020-050, Brazil

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Sleep Wake Disorders; Parasomnias; Motor Activity

Interventions

Exercise; Physical Conditioning, Human; Control Groups

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Lilian KC Reis

  Federal University of São Paulo UNIFESP

  STUDY CHAIR

• Virginia FM Trevisani

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LILIAN REIS

CONTACT

+55 1193869111; lilian.reis2004@terra.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2013
• First Posted: January 16, 2014
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2015
• Last Updated: January 16, 2014

Record last verified: 2013-05

Locations

BR (1)