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

NCT02554474 | Completed Results

• 1 other identifier: H15-01843
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Diseases; Rheumatoid Arthritis; Systemic Lupus Erythematosus

Keywords

Physical activity; Exercise; Rheumatoid; Arthritis; Lupus; SLE

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 9 weeks, 18 weeks, 27 weeks

Secondary Outcomes (8)

• Time Spent in Sedentary Activity

  Baseline, 9 weeks, 18 weeks, 27 weeks

• Fatigue Severity Scale

  Baseline, 9 weeks, 18 weeks, 27 weeks

• McGill Pain Questionnaire Short Form (MPQ-SF)

  Baseline, 9 weeks, 18 weeks, 27 weeks

• The Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 9 weeks, 18 weeks, 27 weeks

• Partners In Health Scale

  Baseline, 9 weeks, 18 weeks, 27 weeks

Study Arms (2)

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.

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.

Behavioral: Same intervention with a 9-week delay

Interventions

Education, Fitbit/FitViz, physiotherapist counselling. BEHAVIORAL

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.

Immediate Group

Same intervention with a 9-week delay BEHAVIORAL

The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 9-week delay.

Delay Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Simon Fraser University: collaborator
• Arthritis Research Centre of Canada: collaborator
• Vancouver General Hospital: collaborator
• The Arthritis Society, Canada: collaborator
• Fraser Health: collaborator

Study Sites (1)

Arthritis Research Canada

Richmond, British Columbia, V6X 2C7, Canada

Location

Related Publications (4)

• 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.

  PMID: 30886950 BACKGROUND

• 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.

  PMID: 32248626 RESULT

• 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.

  PMID: 35303379 RESULT

• Feehan 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.

  PMID: 40217417 DERIVED

MeSH Terms

Conditions

Joint Diseases; Arthritis, Rheumatoid; Lupus Erythematosus, Systemic; Motor Activity; Arthritis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

A limitation is the inclusion of only individuals with rheumatoid arthritis and systemic lupus erythematosus. We focused on these 2 diseases because of feasibility for recruitment in our community. The findings, however, are not generalizable to people with other types of inflammatory arthritis. Furthermore, the results may not be generalizable to men because 89% of the participants were women.

Results Point of Contact

• Title: Dr. Linda Li
• Organization: University of British Columbia

lli@arthritisresearch.ca

604-207-4020

Study Officials

• Linda Li, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 18, 2015
• Study Start: January 1, 2017
• Primary Completion: August 25, 2019
• Study Completion: August 25, 2019
• Last Updated: January 30, 2024
• Results First Posted: June 4, 2021

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)