N/A
N=58
Exercise and Arterial Stiffness in Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT03107442 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Arterial Stiffness — -0.26; -0.22 m/s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aerobic exercise (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arterial Stiffness |
-0.26; -0.22 | — |
| SECONDARY Markers of Inflammation |
0.17; -0.24 | — |
| SECONDARY Glucose |
-3.12; 4.47 | — |
| SECONDARY Insulin |
-0.32; 0.30 | — |
| SECONDARY Homeostasis Model Assessment of Insulin Resistance |
-0.1; 0.22 | — |
| SECONDARY Glycated Hemoglobin |
-0.02; 0.10 | — |
| SECONDARY Lipid |
-2.72; 3.5 | — |
| SECONDARY Cardiorespiratory Fitness |
2.622; 0.43 | — |
| SECONDARY Muscle Strength |
0.91; 0.27 | — |
| SECONDARY Flexibility |
-0.03; -2.66 | — |
| SECONDARY Waist and Hip Circumference |
0.03; 0.02 | — |
| SECONDARY BMI |
0.3; 0.51 | — |
| SECONDARY Coagulation |
29.23; 38.1 | — |
| SECONDARY Renal Function |
0.01; -0.08 | — |
| SECONDARY Health-related Quality of Life |
3.82; 0.21 | — |
| SECONDARY Depression |
-3.32; -1.32 | — |
| SECONDARY Fatigue |
-3; -0.01 | — |
| SECONDARY Sleep Quality |
-0.96; -0.32 | — |
| SECONDARY Sedentary Behavior |
129; 105 | — |
| SECONDARY Adherence to the Mediterranean Diet |
-1.61; 0.71 | — |
| SECONDARY Perceived Stress |
-1.6; -1.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology criteria (presenting at least 4 classification criteria).
- Follow-up of at least 12 months at our Unit.
- Clinical and treatment stability during the 6 months prior to the study.
- Not performing regular exercise (defined as 10 mg/day.
- Background of clinical cardiovascular disease in the last year.
- To present contraindications to perform exercise.
- Other associated rheumatic conditions.
- Pregnancy.
- Acute renal failure.
- Cardiac or pulmonary involvement.
- Body Mass Index > 35
- Not being able to read, understand and sign written informed consent.
Data sourced from ClinicalTrials.gov (NCT03107442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.