Physical Activity in Patients With Systemic Lupus Erythematosus (LESPA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2009 by Federal University of São Paulo.
Recruitment status was: Enrolling by invitation

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

History of Changes

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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, 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:

Genetics Home Reference related topics: systemic lupus erythematosus

MedlinePlus related topics: Health Checkup Lupus

U.S. FDA Resources

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

Primary Outcome Measures:

Life quality [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

Pain [ Time Frame: 12 weeks ]
Strength [ Time Frame: 12 weeks ]
Electromyography [ Time Frame: 12 weeks ]
Aerobic capacity [ Time Frame: 12 weeks ]


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.

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Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
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


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

Keywords provided by Federal University of São Paulo:


Systemic Lupus Erythematosus Activity Physical Activity Disease,trials randomized

Additional relevant MeSH terms:


Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases

ClinicalTrials.gov processed this record on June 23, 2017

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