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OpenTrials
Completed

NCT Number: NCT05287581

Motivating Individuals With Lupus to Exercise

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. Change in Fatigue Severity Scale over time

    Time frame: Baseline, 2, 4, and 6 months

    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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Lupus Foundation of America

Registry information

Official study title

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

Acronym: MOVES

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2022
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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