Physical Activity in Patients With Systemic Lupus Erythematosus (LESPA)
Primary Purpose
Systemic Lupus Erythematosus
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Physical Activity: Cardio training (CT)
Physical Activity: Endurance exercise training (ET)
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, Activity Physical, Activity Disease,trials randomized
Eligibility Criteria
Inclusion Criteria:
(American College of Rheumatology). It is necessary to have the presence of room between the elevens criteria for diagnosis:
- malar erythema
- discoid lesions
- photosensitivity
- oral or nasal ulcers
- arthritis
- serositis
- renal
- neurological
- hematological
- immunological changes
- antinuclear antibodies.
Exclusion Criteria:
- Patients with hemoglobin level 10gm/dL, sequelae of cardiovascular events, - Respiratory diseases (pulmonary hypertension, pulmonary fibrosis
- Bronchitis, asthma, emphysema)
- Heart failure (NYHA> II)
- History of myocardial ischemia or heart
- Blood pressure> 100 mm Hg.
Sites / Locations
- AmbulatoAmbulatory Specialty Interlagos - General Hospital Grajaú - Association Congregation Santa Catarina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Group Control
Endurance
Cardiovascular
Arm Description
Outcomes
Primary Outcome Measures
Life quality
Secondary Outcome Measures
Pain
Strength
Electromyography
Aerobic capacity
Full Information
NCT ID
NCT00985803
First Posted
September 26, 2009
Last Updated
October 7, 2009
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00985803
Brief Title
Physical Activity in Patients With Systemic Lupus Erythematosus
Acronym
LESPA
Official Title
Comparison of Cardiovascular Training Versus Resistance Training In Patients With Systemic Lupus Erythematosus: Controlled Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2009 (undefined)
Study Completion Date
March 2010 (undefined)
3. Sponsor/Collaborators
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 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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic Lupus Erythematosus, Activity Physical, Activity Disease,trials randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Control
Arm Type
No Intervention
Arm Title
Endurance
Arm Type
Experimental
Arm Title
Cardiovascular
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Physical Activity: Cardio training (CT)
Intervention Description
The experimental group of resistance training will carry out the training with 8 kinds 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.
Intervention Type
Other
Intervention Name(s)
Physical Activity: Endurance exercise training (ET)
Intervention Description
The experimental group of resistance training will carry out the training with 8 kinds 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.
Primary Outcome Measure Information:
Title
Life quality
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pain
Time Frame
12 weeks
Title
Strength
Time Frame
12 weeks
Title
Electromyography
Time Frame
12 weeks
Title
Aerobic capacity
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
(American College of Rheumatology). It is necessary to have the presence of room between the elevens criteria for diagnosis:
malar erythema
discoid lesions
photosensitivity
oral or nasal ulcers
arthritis
serositis
renal
neurological
hematological
immunological changes
antinuclear antibodies.
Exclusion Criteria:
Patients with hemoglobin level 10gm/dL, sequelae of cardiovascular events, - Respiratory diseases (pulmonary hypertension, pulmonary fibrosis
Bronchitis, asthma, emphysema)
Heart failure (NYHA> II)
History of myocardial ischemia or heart
Blood pressure> 100 mm Hg.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo I Abrahão
Organizational Affiliation
University Federal of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
AmbulatoAmbulatory Specialty Interlagos - General Hospital Grajaú - Association Congregation Santa Catarina
City
São Paulo
ZIP/Postal Code
04671300
Country
Brazil
12. IPD Sharing Statement
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Physical Activity in Patients With Systemic Lupus Erythematosus
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