- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02554474
OPAM-IA: Using Digital Activity Trackers to Improve Physical Activity in Inflammatory Arthritis
Effective of Online Physical Activity Monitoring in Inflammatory Arthritis (OPAM-IA): A New Model of Care
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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British Columbia
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Richmond, British Columbia, Canada, V6X 2C7
- Arthritis Research Canada
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Immediate Group
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.
|
Participants will receive a brief education session, use a physical activity tracker Fitbit Flex with paired with a FitViz app, and remote counseling by a PT.
Intervention will be received immediately.
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Placebo Comparator: Delay Group
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.
|
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 9-week delay.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Time in Moderate/Vigorous Physical Activity
Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks
|
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.
|
Baseline, 9 weeks, 18 weeks, 27 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Spent in Sedentary Activity
Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks
|
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.
|
Baseline, 9 weeks, 18 weeks, 27 weeks
|
Fatigue Severity Scale
Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks
|
The Fatigue Severity Scale consists of 9 questions and measures the impact of fatigue.
A total score is calculated by averaging the rating from each question.
Range 1-7; lower score = less fatigue.
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Baseline, 9 weeks, 18 weeks, 27 weeks
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McGill Pain Questionnaire Short Form (MPQ-SF)
Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks
|
The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain.
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Baseline, 9 weeks, 18 weeks, 27 weeks
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The Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks
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The PHQ-9 consists of nine questions (rated from 0 to 3) that correspond to nine diagnostic criteria for major depressive disorder.
Range 0-27; lower score = less depressive symptoms),
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Baseline, 9 weeks, 18 weeks, 27 weeks
|
Partners In Health Scale
Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks
|
The Partners in Health Scale is a 12-item measure designed to assess self-efficacy, knowledge of health conditions and treatment, and self-management behaviors such as adopting a healthy lifestyle.
Range 0-96; higher score = higher perceived confidence and ability in self-care.
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Baseline, 9 weeks, 18 weeks, 27 weeks
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The Self-Reported Habit Index (SRHI) - Sitting at Work Index
Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks
|
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior.
Participants rated their strength of habit of sitting at work.
A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it.
Range 1-7; higher score = stronger habit.
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Baseline, 9 weeks, 18 weeks, 27 weeks
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The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index
Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks
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The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior.
Participants rated their strength of habit of sitting at leisure.
A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it.
Range 1-7; higher score = stronger habit.
|
Baseline, 9 weeks, 18 weeks, 27 weeks
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The Self-Reported Habit Index (SRHI) - Walking Index
Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks
|
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior.
Participants rated their strength of walking habit.
A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it.
Range 1-7; higher score = stronger habit.
|
Baseline, 9 weeks, 18 weeks, 27 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Linda Li, PhD, Professor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H15-01843
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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