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Exercise and Arterial Stiffness in Systemic Lupus Erythematosus

NCT03107442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-08-22

Study results available
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Summary

Patients with Systemic Lupus Erythematosus (SLE) have increased arterial stiffness, which leads to cardiovascular diseases (CVD) of arteriosclerotic origin, which are the main cause of mortality in these patients. Exercise is a modifiable factor that reduces cardiovascular mortality and associated risk factors in the general population. Preliminary studies suggest that exercise may improve endothelial function and lipid profile in patients with SLE. However, whether meeting the international physical activity guidelines from the American College of Sports Medicine (ACSM; i.e. ≥150 min / week of moderate to vigorous intensity physical activity) can improve arterial stiffness (subclinical atherosclerosis marker) and inflammation is unknown.

The primary aim of this study is to assess the effect of an exercise program based on meeting the ACSM physical activity guidelines on arterial stiffness and inflammation in patients with SLE.

The secondary aim is to assess the effect of an exercise program based on meeting the ACSM physical activity guidelines on endothelial function, oxidative stress, as well as other cardiometabolic risk factors, physical fitness, health-related quality of life, and other psychosocial outcomes.

Our hypothesis is that meeting the ACSM guidelines will improve arterial stiffness and inflammation in patients with SLE.

The study is a non-randomized clinical trial. To minimize selection bias, participants in the intervention and control groups will be matched by age, BMI, and disease activity (SLEDAI), which are important contributors to arterial stiffness.

Conditions

Interventions

BEHAVIORAL

Aerobic exercise

12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

    lead OTHER

Principal Investigators

  • José A. Vargas-Hitos, MD, Ph.D. · Virgen de las Nieves University Hospital, Granada, Spain

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-12
Primary Completion
2017-07-21
Completion
2017-07-21

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03107442 on ClinicalTrials.gov