NCT01515163

Brief Summary

The investigators hypothesize that a three-month aerobic exercise training program will positively affect the lipid profile, insulin sensitivity , cytokine profile, the cardiovascular parameters and muscle strength in SLE patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

5.2 years

First QC Date

January 12, 2012

Last Update Submit

January 12, 2016

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (3)

  • Lipid profile - Plasma levels of total cholesterol (mg/dl), VLDL-chol (mg/dl) HDL-chol (mg/dl), LDL-chol (mg/dl), triglycerides (mg/dl), Apolipoprotein AI and AII (mg/dl) and Apolipoprotein B (mg/dl)

    3 months

  • Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp

    3 months

  • Cytokine response - Plasma levels of TNF-α (pg/ml), IL-6 (pg/ml), IFN-type I (pg/ml), IL-10 (pg/ml)and IL-1ra (pg/ml)

    3 months

Secondary Outcomes (2)

  • Cardiovascular parameters

    3 months

  • Muscle Strength

    3 months

Study Arms (3)

Exercise

EXPERIMENTAL

3-month exercise training program

Behavioral: Exercise training

Control

NO INTERVENTION

Control group

Healthy control

EXPERIMENTAL
Behavioral: Exercise training

Interventions

Exercise trainingBEHAVIORAL

Aerobic exercise training, two times a week

ExerciseHealthy control

Eligibility Criteria

Age7 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 7 and 40 years
  • SLEDAI ≤ 4

You may not qualify if:

  • Cardiovascular dysfunction
  • Rhythm and conduction disorders
  • Musculoskeletal disturbances
  • Kidney and pulmonary involvements
  • Peripheral neuropathy
  • Use of tobacco
  • Treatment with lipid-lowering or hypoglycemic drugs
  • Fibromyalgia
  • Use of chronotropic or antihypertensive drugs
  • Physically active subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (3)

  • Benatti FB, Miyake CNH, Dantas WS, Zambelli VO, Shinjo SK, Pereira RMR, Silva MER, Sa-Pinto AL, Borba E, Bonfa E, Gualano B. Exercise Increases Insulin Sensitivity and Skeletal Muscle AMPK Expression in Systemic Lupus Erythematosus: A Randomized Controlled Trial. Front Immunol. 2018 Apr 27;9:906. doi: 10.3389/fimmu.2018.00906. eCollection 2018.

    PMID: 29755474DERIVED

  • Benatti FB, Miossi R, Passareli M, Nakandakare ER, Perandini L, Lima FR, Roschel H, Borba E, Bonfa E, Gualano B, de Sa Pinto AL. The effects of exercise on lipid profile in systemic lupus erythematosus and healthy individuals: a randomized trial. Rheumatol Int. 2015 Jan;35(1):61-9. doi: 10.1007/s00296-014-3081-4. Epub 2014 Jun 28.

    PMID: 24972700DERIVED

  • Prado DM, Benatti FB, de Sa-Pinto AL, Hayashi AP, Gualano B, Pereira RM, Sallum AM, Bonfa E, Silva CA, Roschel H. Exercise training in childhood-onset systemic lupus erythematosus: a controlled randomized trial. Arthritis Res Ther. 2013 Mar 26;15(2):R46. doi: 10.1186/ar4205.

    PMID: 23531226DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Assistant Professor

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 23, 2012

Study Start

May 1, 2010

Primary Completion

July 1, 2015

Study Completion

July 1, 2016

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

BR(1)