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Clinical Trials/NCT05287581
NCT05287581
Completed
Not Applicable

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

University of Michigan1 site in 1 country32 target enrollmentJanuary 17, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Systemic Lupus Erythematosus
Sponsor
University of Michigan
Enrollment
32
Locations
1
Primary Endpoint
Change in physical activity over time
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 17, 2022
End Date
October 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dominique Kinnett-Hopkins

Assistant Professor

University of Michigan

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

Outcomes

Primary Outcomes

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.

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

  • Change in Fatigue Severity Scale over time(Baseline, 2, 4, and 6 months)

Study Sites (1)

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