Motivating Individuals With Lupus to Exercise (MOVES)

A Progressive Home-based Exercise Intervention for Persons With Systemic Lupus Erythematosus

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 Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Behavioral: MOVES

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: MOVES; 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.
No Intervention: Waitlist Control; 24-week waitlist control condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity over time	Actigraph accelerometers will be worn by participants on an elastic belt around their waist for 7 days.	Baseline and 4 months
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.	Baseline, 2, 4, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 2, 4, and 6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Lupus Foundation of America

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: HUM00207257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No