Clinical trial NCT02554474: OPAM-IA: Using Digital Activity Trackers to Improve Physical Activity in Inflammatory Arthritis
Official title: Effective of Online Physical Activity Monitoring in Inflammatory Arthritis (OPAM-IA): A New Model of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Diseases
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Keywords: Physical activity
Exercise
Rheumatoid
Arthritis
Lupus
SLE
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Simon Fraser University
name: Arthritis Research Centre of Canada
name: Vancouver General Hospital
name: The Arthritis Society, Canada
name: Fraser Health
First posted: 2015-09-18
Enrollment: 118
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Being physically active can reduce pain and fatigue, improve mobility and enhance quality of life in people with arthritis, but adherence to an active lifestyle is poor, with less than half of people with arthritis being active. The primary goal of this randomized controlled trial is to assess the efficacy of a physical activity coaching model to improve physical activity participation and reduce sedentary time in patients with Rheumatoid Arthritis and Systemic Lupus Erythematosus. This model combines the use of a Fitbit Flex (wireless physical activity tracker) paired with a FitViz application, a group education session, and telephone counselling by a physiotherapist.

Detailed description: Patient self-management is a fundamental component in arthritis care that is often neglected. Physical activity is an essential part of self-management, however, less than half of people with arthritis are active. There are several factors that are associated with low physical activity participation such as motivation, doubts about the effectiveness of prescribed exercises, and lack of health professional advice on ways to progress physical activity. The variety of risk factors highlights the need for a multifaceted approach that provides support in terms of knowledge, skill development and timely advice from health professionals, as well as motivational support to stay active.

Our primary objective is to assess the efficacy of a physical activity counselling model, involving the use of a Fitbit Flex (wireless physical activity tracker) paired with a FitViz application (app), a group education session, and telephone counselling by a physiotherapist, to improve physical activity participation in patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Our secondary objective is to assess the effect of the intervention on reducing patients' sedentary time, and improving fatigue, mood, pain, and self-efficacy in arthritis management. We will carry out three aims: 1) To develop the FitViz app to pair with Fitbit to enhance user experience, 2) To conduct a pilot test for the Fitbit/FitViz intervention, 3) To evaluate the effect of the physical activity coaching model in patients with RA and SLE. In this proof-of-concept randomized controlled trial (RCT), the investigators hypothesize that compared to a control group (i.e. the Delayed Intervention group), participants in the Immediate Intervention Group will 1) increase moderate/vigorous physical activity (MVPA), 2) reduce sedentary time, 3) improve in fatigue, mood, and pain levels, and 4) improve in their self-efficacy in disease management.

The investigators will use a mixed-methods approach, involving a RCT and in-depth interviews. The proof-of-concept study will employ a stepped wedge RCT design, whereby the intervention will be sequentially rolled out to participants over a number of time periods. The order in which individuals receive the intervention will be determined at random. The strength of this design is that it can properly address the efficacy question, while avoiding the dilemma of withholding the intervention to some participants, as in a parallel group design.

Eligibility criteria: Inclusion Criteria:

* Have a physician confirmed diagnosis of RA or SLE.
* Have an email address and daily access to a computer with internet connection.
* Be able to attend a 1.5-hour education session at Mary Pack Arthritis Centre, Arthritis Research Centre, or a Fraser Health site.

Exclusion Criteria:

* Have previously used any physical activity wearables.
* Face a level of risk by exercising as identified by the Physical Activity Readiness Questionnaire (PAR-Q).

Primary outcomes:
measure: Daily Time in Moderate/Vigorous Physical Activity
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary outcomes:
measure: Time Spent in Sedentary Activity
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: Fatigue Severity Scale
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: McGill Pain Questionnaire Short Form (MPQ-SF)
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: Partners In Health Scale
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: The Self-Reported Habit Index (SRHI) - Sitting at Work Index
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
measure: The Self-Reported Habit Index (SRHI) - Walking Index
timeFrame: Baseline, 9 weeks, 18 weeks, 27 weeks
Other outcomes:
Locations:
city: Richmond
country: Canada
facility: Arthritis Research Canada
state: British Columbia
Study officials:
affiliation: Professor
name: Linda Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li LC, Feehan LM, Shaw C, Xie H, Sayre EC, Avina-Zubeita A, Grewal N, Townsend AF, Gromala D, Noonan G, Backman CL. A technology-enabled Counselling program versus a delayed treatment control to support physical activity participation in people with inflammatory arthritis: study protocol for the OPAM-IA randomized controlled trial. BMC Rheumatol. 2017 Nov 28;1:6. doi: 10.1186/s41927-017-0005-4. eCollection 2017.
citation: Li LC, Feehan LM, Xie H, Lu N, Shaw C, Gromala D, Avina-Zubieta JA, Koehn C, Hoens AM, English K, Tam J, Therrien S, Townsend AF, Noonan G, Backman CL. Efficacy of a Physical Activity Counseling Program With Use of a Wearable Tracker in People With Inflammatory Arthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2020 Dec;72(12):1755-1765. doi: 10.1002/acr.24199.
citation: Leese J, Zhu S, Townsend AF, Backman CL, Nimmon L, Li LC. Ethical issues experienced by persons with rheumatoid arthritis in a wearable-enabled physical activity intervention study. Health Expect. 2022 Aug;25(4):1418-1431. doi: 10.1111/hex.13481. Epub 2022 Mar 18.