Motivating Individuals With Lupus to Exercise

Systemic Lupus Erythematosus Clinical Trial

— MOVES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05287581
• Other study ID #: HUM00207257
• Status: Completed
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Lupus Foundation of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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