Back to resultsMotivating Individuals With Lupus to Exercise (MOVES)
Primary Purpose
Systemic Lupus Erythematosus
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MOVES
Sponsored by
About this trial
This is an interventional supportive care trial for Systemic Lupus Erythematosus
Eligibility Criteria
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Waitlist Control
Arm Description
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.
24-week waitlist control condition
Outcomes
Primary Outcome Measures
Change in physical activity over time
Actigraph accelerometers will be worn by participants on an elastic belt around their waist for 7 days.
Change in Exercise over time
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 Outcome Measures
Change in Fatigue Severity Scale over time
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
Full Information
NCT ID
NCT05287581
First Posted
March 9, 2022
Last Updated
January 24, 2023
Sponsor
University of Michigan
Collaborators
Lupus Foundation of America
1. Study Identification
Unique Protocol Identification Number
NCT05287581
Brief Title
Motivating Individuals With Lupus to Exercise
Acronym
MOVES
Official Title
A Progressive Home-based Exercise Intervention for Persons With Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Lupus Foundation of America
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
24-week waitlist control condition
Intervention Type
Behavioral
Intervention Name(s)
MOVES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in physical activity over time
Description
Actigraph accelerometers will be worn by participants on an elastic belt around their waist for 7 days.
Time Frame
Baseline and 4 months
Title
Change in Exercise over time
Description
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.
Time Frame
Baseline, 2, 4, and 6 months
Secondary Outcome Measure Information:
Title
Change in Fatigue Severity Scale over time
Description
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
Time Frame
Baseline, 2, 4, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Motivating Individuals With Lupus to Exercise
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