Exercise and Arterial Stiffness in Systemic Lupus Erythematosus

NCT03107442 | Completed Results

• 1 other identifier: PI-0525-2016
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Systemic Lupus Erythematosus

Keywords

Arterial stiffness; Markers of Inflammation; Exercise; Physical fitness; Cardiovascular risk; Autoimmune diseases

Outcome Measures

Primary Outcomes (1)

• Arterial Stiffness

  Pulse wave velocity assessed with Mobil-OGraph ® 24h pulse wave analysis monitor (IEM GmbH, Stolberg, Germany)

  value at 12 weeks minus value at baseline

Secondary Outcomes (20)

• Markers of Inflammation

  Change from baseline to week 12

• Glucose

  Change from baseline to week 12

• Insulin

  Change from baseline to week 12

• Homeostasis Model Assessment of Insulin Resistance

  Change from baseline to week 12

• Glycated Hemoglobin

  Change from baseline to week 12

Study Arms (2)

Exercise

EXPERIMENTAL

12-weeks aerobic exercise intervention

Behavioral: Aerobic exercise

Control

NO INTERVENTION

Usual care, with recommendations for a healthy lifestyle.

Interventions

Aerobic exercise BEHAVIORAL

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.

Exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 60min/week of structured exercise)

You may not qualify if:

• Biological treatment in the previous 6 months or to need prednisone dosis \>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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental: lead

Study Sites (1)

Virgen de las Nieves University Hospital

Granada, 18014, Spain

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Motor Activity; Autoimmune Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

This study has several limitations. First, the final sample size was relatively small and was calculated to assess the between-group change in arterial stiffness as the primary trial outcome. Consequently, the power to detect significant between-group differences in the outcomes reported was checked.

Results Point of Contact

• Title: Dr José Antonio Vargas-Hitos
• Organization: FIBAO

joseantoniovh@hotmail.com

625943933

Study Officials

• José A. Vargas-Hitos, MD, Ph.D.

  Virgen de las Nieves University Hospital, Granada, Spain

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: José A. Vargas-Hitos, MD, PhD

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 11, 2017
• Study Start: April 12, 2017
• Primary Completion: July 21, 2017
• Study Completion: July 21, 2017
• Last Updated: August 22, 2024
• Results First Posted: August 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)