OPAM-IA: Using Digital Activity Trackers to Improve Physical Activity in Inflammatory Arthritis

University of British Columbia

Status: Completed

Conditions: Joint Diseases; Systemic Lupus Erythematosus; Rheumatoid Arthritis

Treatments: Behavioral: Education, Fitbit/FitViz, physiotherapist counselling.; Behavioral: Same intervention with a 9-week delay

Study type: Interventional

Funder types: Other

Identifiers

NCT02554474

H15-01843

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

118 participants in 2 patient groups, including a placebo group

Immediate Group

Active Comparator group

Description:

Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated in bouted MVPA per day. A bout is defined as \>= 10 consecutive minutes or more at the level of \>= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to two minutes below the threshold.

Treatment:

Behavioral: Education, Fitbit/FitViz, physiotherapist counselling.

Delay Group

Placebo Comparator group

Description:

Time spent in sedentary activity was measured with a SenseWear Mini sensor over a 7-day period. The mean daily time spent in sedentary activity was calculated with an energy expenditure of \<=1.5 METs, occurring in bouts of \>= 20 minutes during waking hours.

Treatment:

Behavioral: Same intervention with a 9-week delay