Systemic Lupus Erythematosus Clinical Trial
Official title:
Comparison of Cardiovascular Training Versus Resistance Training In Patients With Systemic Lupus Erythematosus: Controlled Randomized Clinical Trial
The purpose of this study is to check the improvement in quality of life in patients with
systemic lupus incorporated into a routine of physical activity.
Randomized controlled blinded trial, 63 patients aged 42.9 ± 14.4 and diagnosis of systemic
lupus erythematosus (SLE) according to the criteria of the College American Rheumatology,
1997. After randomization patients were allocated into 3 groups, control group (CG) (n =
21), training cardiovascular (CT) (n = 20), resistance training (RT) (n = 22), performing 12
weeks of intervention with a frequency of three times weeks and were evaluated at two
different times (T0 and T12). As primary outcome quality of life was assessed by the
inventory Generic Assessment of quality of life by the Medical Outcomes Study 36 -- Healthy
ItemShort Form Survey (SF36) and as secondary outcomes functional capacity evaluation of
pain symptoms (visual scale analogue pain [VAS]), intensity of symptoms of depression (Beck
Depression Inventory [BDI]), index of disease activity (Systemic Lupus Disease Activity
Inventory Erythmatodud [SLEDAI]), capacity aerobic (walking test of 12 minutes [T12]),
subjective perception effort (subjective scale of Borg [Borg]), limb muscle strength lower
(analog dynamometer [strength]), electrical activity member lower (surface electromyography
[EMG]), amount of products (inventory amount of Medicines).
Will be selected 60 patients of both genders aged between 18 -55 years, with make the
diagnosis of SLE by the criteria of the Americam College of Rheumatology revised in 1997 and
that are not physically active.
After screening, patients will read and sign the informed consent form. The study will be
submitted to the ethics committee of the Federal University of São Paulo / Escola Paulista
de Medicina.
Randomization will be done by a secretary using a computer program specifically for this
purpose, where the groups will be divided into intervention and control. The random
allocation will be maintained using opaque sealed envelopes, which will open at the time of
intervention.
Control group will not perform any type of training. Since the experimental group will be
divided into two groups, cardio training (CT) and endurance exercise training (ET).
Evaluation will be conducted at the beginning and end of 12 weeks by two raters blind (who
will not know to which groups, individuals were allocated) that will use the following
tools:
- Outcomes
- Assessment of pain
- Assessment of pain before and after training, the visual analog scale of pain, ranging
from 0 (zero) no pain and 10 cm (ten) 14 unbearable pain
Evaluation of the depression:
Evaluation of the depression at the beginning and end of the proposed training, inventory
Beck Depression Inventory. (BDI). This inventory of multiple choice will be used to measure
the severity of depression. These include symptoms of depression, irritability, cognitive
impairment, guilt, feelings of being punished, physical symptoms such as fatigue, weight
loss, lack of interest in sex.
Assessment of quality of life:
Generic Assessment of quality of life by the SF 36 (Short From 36), beginning and end of the
proposed treatment. Validated in Portuguese in 1999 (Ciconelli et al, 1999). It consists of
eight domains (physical functioning, limitation in physical appearance, bodily pain, general
health, vitality, social, emotional, and mental health ranging from 0 (zero) to 100 (one
hundred), and the higher the note is better quality of life.
Activity disease:
Activity Level by Systemic Lupus Erythematosus Disease Activity Inventory (SLEDAI) at the
beginning and end of the proposed treatment.
Aerobic Capacity:
Cooper test of walking and / or running in 12 minutes. Only for the experimental group of
aerobic training, aiming to prescribe the training range cardiovascular.O test aims to
measure the aerobic capacity of subjects. The test results will be classified as "VERY
GOOD", "GOOD", "MIDDLE", "BAD", "very poor", which will be based on distance traveled, age
and sex of the individual being evaluated.
Muscle strength:
Evaluation of muscle strength through a load cell placed in a leg extension to 60 degrees of
extension.
Activity Muscle:
Assessment of quadriceps muscle activation using electromyography
The experimental group of cardiovascular training will hold a training still between 55% to
65% of maximum heart rate ..
The experimental group of resistance training will carry out the training with 8 years of
training session with 12 reps with that load will vary according to the 1 RM test.
The composition of the training session is 10 minutes of heating and stretching, 40 minutes
of cardiovascular training and 10 minutes of cooling.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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