Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02037971
Other study ID # 03315312.8.0000.5505
Secondary ID
Status Recruiting
Phase N/A
First received March 24, 2013
Last updated January 14, 2014
Start date February 2013
Est. completion date March 2015

Study information

Verified date May 2013
Source Federal University of São Paulo
Contact LILIAN REIS
Phone +55 1193869111
Email lilian.reis2004@terra.com.br
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 2015
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 69 Years
Eligibility 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);

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Intervention

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

Locations

Country Name City State
Brazil Psychobiology and Exercise Studies Centre São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Primary 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 Yes
Secondary 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. 16 weeks Yes
Secondary 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. 16 weeks Yes
Secondary Quality of life assessment Subjects' health will be evaluated utilizing the questionnaire 'Short Form (36) Health Survey' (SF-36). 16 weeks Yes
Secondary 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. 16 weeks Yes
Secondary 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. 16 weeks Yes
Secondary 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. 16 weeks Yes
See also
  Status Clinical Trial Phase
Terminated NCT03843125 - A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) Phase 3
Recruiting NCT05698173 - Systemic Lupus Erythematosus and Accelerated Aging N/A
Active, not recruiting NCT01649765 - Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy Phase 2
Recruiting NCT05704153 - Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A) N/A
Completed NCT05048238 - Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus Phase 1
Recruiting NCT06056778 - The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
Completed NCT04358302 - Individual Patient Exposure and Response in Pediatric Lupus N/A
Completed NCT03802578 - The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients N/A
Completed NCT02554019 - Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus Phase 2
Recruiting NCT04835883 - Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients Phase 2
Terminated NCT02665364 - Phase IIb Study of IFN-K in Systemic Lupus Erythematosus Phase 2
Completed NCT00278538 - Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus Phase 2
Completed NCT00069342 - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed NCT03252587 - An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus Phase 2
Terminated NCT02066311 - Nelfinavir in Systemic Lupus Erythematosus Phase 2
Recruiting NCT01892748 - Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus. N/A
Terminated NCT01689025 - An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE) Phase 1
Unknown status NCT01712529 - Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients N/A
Completed NCT01475149 - Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE) N/A
Completed NCT00962832 - A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus Phase 2