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Physical Activity in Patients With Systemic Lupus Erythematosus (LESPA)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00985803
First received: September 26, 2009
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

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).


Condition Intervention Phase
Systemic Lupus Erythematosus
Other: Physical Activity: Cardio training (CT)
Other: Physical Activity: Endurance exercise training (ET)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Cardiovascular Training Versus Resistance Training In Patients With Systemic Lupus Erythematosus: Controlled Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Life quality [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Strength [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Electromyography [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Aerobic capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Group Control
Experimental: Endurance Other: 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.

Experimental: Cardiovascular 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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985803

Locations
Brazil
AmbulatoAmbulatory Specialty Interlagos - General Hospital Grajaú - Association Congregation Santa Catarina
São Paulo, Brazil, 04671300
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Marcelo I Abrahão University Federal of São Paulo
  More Information

No publications provided

Responsible Party: Marcelo Ismael Abrahão, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00985803     History of Changes
Other Study ID Numbers: MAbrahao
Study First Received: September 26, 2009
Last Updated: October 7, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Systemic Lupus Erythematosus
Activity Physical
Activity Disease,trials randomized

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on November 25, 2014