Exercise and Systemic Lupus Erythematosus

NCT ID: NCT01515163

Last Updated: 2016-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Lupus Erythematosus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise

3-month exercise training program

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

Aerobic exercise training, two times a week

Control

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy control

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

Aerobic exercise training, two times a week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise training

Aerobic exercise training, two times a week

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age between 7 and 40 years
* SLEDAI ≤ 4

Exclusion Criteria

* 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
Minimum Eligible Age

7 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bruno Gualano

PhD, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29755474 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24972700 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23531226 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Lupus and exercise

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Systemic Lupus Erythematosus
NCT05984316 UNKNOWN NA
Lupus Intervention for Fatigue Trial
NCT02653287 ACTIVE_NOT_RECRUITING NA
Interleukin23 in Systemic Lupus
NCT06713187 RECRUITING NA