Joint DiseasesNCT02554474
OPAM-IA: Using Digital Activity Trackers to Improve Physical Activity in Inflammatory Arthritis
A study testing Education, Fitbit/FitViz, physiotherapist counselling. and Same intervention with a 9-week delay in people with Joint Diseases and Rheumatoid Arthritis, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Joint Diseases, Rheumatoid Arthritis, Systemic Lupus Erythematosus
- What is being tested?
- Education, Fitbit/FitViz, physiotherapist counselling. and Same intervention with a 9-week delay
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2017to 25 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effective of Online Physical Activity Monitoring in Inflammatory Arthritis (OPAM-IA): A New Model of Care
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.
Read the 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.
- Being tested
- Education, Fitbit/FitViz, physiotherapist counselling., Same intervention with a 9-week delay
- Keywords
- Physical activity, Exercise, Rheumatoid, Arthritis, Lupus, SLE
- Medical subject headings
- Joint Diseases, Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Motor Activity, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education, Fitbit/FitViz, physiotherapist counselling.Behavioural
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.
Same intervention with a 9-week delayBehavioural
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 9-week delay.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Group | Active comparator | 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. Receives: Behavioral: Education, Fitbit/FitViz, physiotherapist counselling. |
| Delay Group | Placebo comparator | 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. Receives: Behavioral: Same intervention with a 9-week delay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Time in Moderate/Vigorous Physical Activity
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.
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary outcomes (8)
Time Spent in Sedentary Activity
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.
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
Fatigue Severity Scale
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.
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
McGill Pain Questionnaire Short Form (MPQ-SF)
The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain.
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
The Patient Health Questionnaire-9 (PHQ-9)
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),
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
Partners In Health Scale
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.
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
The Self-Reported Habit Index (SRHI) - Sitting at Work Index
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.
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index
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.
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
The Self-Reported Habit Index (SRHI) - Walking Index
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.
Measured: Baseline, 9 weeks, 18 weeks, 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start1 Jan 2017
- Primary completion25 Aug 2019
- Study completion25 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Joint DiseasesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Simon Fraser University, Arthritis Research Centre of Canada, Vancouver General Hospital, The Arthritis Society, Canada, Fraser Health
- Responsible party
- Principal investigator, Linda Li, University of British Columbia
- Investigators
- Linda Li, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554474
- Sponsor's protocol ID
- H15-01843
- Status last verified
- Jan 2024
- First submitted
- 16 Sep 2015
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30886950Li 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.
PubMed 32248626Leese 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.
PubMed 35303379Feehan L, Xie H, Lu N, Li LC. Twenty-four hour physical activity, sedentary behaviour and sleep profiles in adults living with rheumatoid arthritis: a cross-sectional latent class analysis. J Act Sedentary Sleep Behav. 2024 Apr 17;3(1):10. doi: 10.1186/s44167-024-00049-5.
PubMed 40217417
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective of Online Physical Activity Monitoring in Inflammatory Arthritis (OPAM-IA): A New Model of Care
- ClinicalTrials.gov ID
- NCT02554474
- Acronym / sponsor ID
- H15-01843
- Keywords
- Physical activity, Exercise, Rheumatoid, Arthritis, Lupus, SLE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Simon Fraser University, Arthritis Research Centre of Canada, Vancouver General Hospital, The Arthritis Society, Canada, Fraser Health
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 25 Aug 2019 (actual)
- Study completion
- 25 Aug 2019 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Posted 4 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Group | Active comparator | Behavioral: Education, Fitbit/FitViz, physiotherapist counselling.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. |
| Delay Group | Placebo comparator | Behavioral: Same intervention with a 9-week delayTime 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Have previously used any physical activity wearables.
- Face a level of risk by exercising as identified by the Physical Activity Readiness Questionnaire (PAR-Q).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education, Fitbit/FitViz, physiotherapist counselling.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. | Behavioural | Immediate Group |
| Same intervention with a 9-week delayThe Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 9-week delay. | Behavioural | Delay Group |
Primary outcome
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.
8 secondary outcomes
Time Spent in Sedentary Activity
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Fatigue Severity Scale
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
McGill Pain Questionnaire Short Form (MPQ-SF)
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Partners In Health Scale
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
The Self-Reported Habit Index (SRHI) - Sitting at Work Index
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
The Self-Reported Habit Index (SRHI) - Walking Index
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30886950Li 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.
- Results publication: PubMed 32248626Li 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.
- Results publication: PubMed 35303379Leese 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.
- Derived from this study: PubMed 40217417Feehan L, Xie H, Lu N, Li LC. Twenty-four hour physical activity, sedentary behaviour and sleep profiles in adults living with rheumatoid arthritis: a cross-sectional latent class analysis. J Act Sedentary Sleep Behav. 2024 Apr 17;3(1):10. doi: 10.1186/s44167-024-00049-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Li, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Fitbit/FitViz, physiotherapist counselling. and Same intervention with a 9-week delay in people with Joint Diseases and Rheumatoid Arthritis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Time in Moderate/Vigorous Physical Activity (time frame: Baseline, 9 weeks, 18 weeks, 27 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02554474, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.