Physical Activity in Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

— LESPA  

Official title:

Comparison of Cardiovascular Training Versus Resistance Training In Patients With Systemic Lupus Erythematosus: Controlled Randomized Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00985803
• Other study ID #: MAbrahao
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: September 26, 2009
• Last updated: October 7, 2009
• Start date: November 2009
• Est. completion date: March 2010

Study information

• Verified date: October 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: March 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Other:
• Physical Activity: Cardio training (CT)
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.
• Physical Activity: Endurance exercise training (ET)
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.

Locations

Country	Name	City	State
Brazil	AmbulatoAmbulatory Specialty Interlagos - General Hospital Grajaú - Association Congregation Santa Catarina	São Paulo

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	Life quality		12 weeks	Yes
Secondary	Pain		12 weeks	Yes
Secondary	Strength		12 weeks	Yes
Secondary	Electromyography		12 weeks	Yes
Secondary	Aerobic capacity		12 weeks	Yes