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Aerobic Exercise in Women With Systemic Lupus Erythematosus

NCT03186794 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-05-10

Study results available
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Summary

Background:

As many as 1.5 million Americans are living with systemic lupus erythematosus (Lupus). Lupus makes people very tired. It also makes it hard for people to be physically active. Studies have shown that aerobic exercise training helps people with heart or lung illnesses be less tired and more active. Researchers want to use an exercise training program on people with Lupus to see if it has the same results.

Objectives:

To find out if aerobic exercise helps people with Lupus be less tired and more active.

Eligibility:

Women ages 21-80 who have Lupus and are not physically active.

Design:

Participants will be screened with a medical history and physical exam. They will have heart and lung tests, as well as blood and urine tests. They will also answer questions about their quality of life and take a test that measures lupus activity.

The study will last 14-16 weeks.

For the first two study visits, participants will do treadmill exercise tests and answer more quality of life questions. For these treadmill tests, participants will wear sensors, a mask, or a mouthpiece while they exercise.

Participants will then begin exercise training, 3 times a week for 12 weeks. At each of these visits, they will walk very fast for 30 minutes on a track or a treadmill. Each visit will last about 1 hour.

At the halfway point of the study, participants will repeat some of the screening tests. This visit will last about 3 hours.

At the end of the study, participants will repeat the screening tests. They will also repeat the treadmill exercise tests.

Conditions

Interventions

OTHER

Treadmill exercise training

30 minutes of continuous treadmill walking at a target intensity or use of an interval approach in which walking at the target will be sustained at smaller training interval durations of no shorter than 5 minutes followed by an active rest interval that is no longer than 1.5 times the training interval until the subject achieves a total exercise time of 30 minutes, excluding the rest intervals. Each session will last about 60 minutes but slightly longer if an interval approach is used.

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Leighton Chan, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-22
Primary Completion
2021-02-25
Completion
2021-02-25

Countries

  • United States

Study Locations

More Related Trials

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 NCT03186794 on ClinicalTrials.gov