Motivating Individuals With Lupus to Exercise

NCT05287581 | Completed DMC

• 1 other identifier: HUM00207257
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Fatigue Severity Scale over time

  Baseline, 2, 4, and 6 months

Study Arms (2)

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

Waitlist Control

NO INTERVENTION

24-week waitlist control condition

Interventions

MOVES BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• moderate or high risk for undertaking physical activity

Sponsors & Collaborators

• University of Michigan: lead
• Lupus Foundation of America: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 18, 2022
• Study Start: January 17, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)