CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
Aerobic exercisebehavioral
Likely dose
≥150 minutes per week of moderate to vigorous aerobic exercise (40-85% of heart rate reserve) on treadmill for 12 weeksAI-extracted
Key inclusion· 4
  • Diagnosis of Systemic Lupus Erythematosus (SLE) according to American College of Rheumatology criteria with at least 4 classification criteria
  • At least 12 months of follow-up at the study unit
  • Clinical and treatment stability during the 6 months prior to study enrollment
  • Currently sedentary: less than 60 minutes per week of structured exercise
Key exclusion· 8
  • Biological treatment in the previous 6 months or requirement for prednisone dose >10 mg/day
  • Clinical cardiovascular disease within the past year
  • Contraindications to performing exercise
  • Other associated rheumatic conditions

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03107442
NCT03107442N/ACompleted

Effects of an Aerobic Exercise Intervention Program on Arterial Stiffness and Inflammation in Women With Systemic Lupus Erythematosus

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental·interventional·Posted Apr 11, 2017·Updated Aug 22, 2024

In Brief

A clinical study evaluating Aerobic exercise for Systemic Lupus Erythematosus. Completed, enrolled 58 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 11, 2017
Enrollment StartApr 12, 2017
Primary CompletionJul 21, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.2 years ago

Interventions

Aerobic exercisebehavioral

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.