Systemic Lupus Erythematosus
Conditions
Brief summary
Physical activity and exercise are helpful for managing symptoms like fatigue in people living with systemic lupus erythematosus (lupus; SLE). Despite research supporting physical activity participation, people with lupus are often inactive and report being afraid to exercise. To that end, this project is a pilot randomized controlled trial for examining the efficacy of a home-based behavioral intervention based on social cognitive theory and motivational interviewing for increasing physical activity and decreasing fatigue.
Interventions
BEHAVIORALMOVES
The experimental intervention is a 16-week progressive home-based exercise program in which participants are supported through seven coaching calls based on social cognitive theory and motivational interviewing principles. The individual sessions will provide tailored support for increasing physical activity behavior towards the recommended guidelines of at least 150 minutes of moderate aerobic activity and two strength-training sessions per week. There are no drugs involved in the intervention.
Sponsors
Lupus Foundation of America
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of Lupus * be able to speak and read English * being non-active defined as not engaging in regular activity (150 minutes or more of moderate physical activity per week) * being impacted by fatigue defined as a score of 36 or higher on the fatigue severity scale
Exclusion criteria
* moderate or high risk for undertaking physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical activity over time | Baseline and 4 months | Actigraph accelerometers will be worn by participants on an elastic belt around their waist for 7 days. |
| Change in Exercise over time | Baseline, 2, 4, and 6 months | The Godin Leisure-Time Exercise Questionnaire (GLTEQ) will be administered. The GLTEQ measures the frequency of strenuous, moderate, and mild leisure activity performed for periods of 15 min or more over a usual week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue Severity Scale over time | Baseline, 2, 4, and 6 months | The Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activity and lifestyle. The items are scored on a 7-point scale with 1 = strongly disagree and 7 = strongly agree. The minimum score is 9, and the maximum score possible is 63. The higher the score, the greater the fatigue severity |
Countries
United States
Outcome results
None listed