A Progressive Home-based Exercise Intervention for Persons With Systemic Lupus Erythematosus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change in physical activity over time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Experimental
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.
Intervention: MOVES (Behavioral)
Waitlist Control
24-week waitlist control condition
Outcomes
Primary Outcomes
Change in physical activity over time
Time Frame: 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
Time Frame: 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 Outcomes
- Change in Fatigue Severity Scale over time(Baseline, 2, 4, and 6 months)
Investigators
Dominique Kinnett-Hopkins
Assistant Professor
University of Michigan