SuPRA: Using Wearable Activity Trackers With a New Application to Improve Physical Activity in Knee Osteoarthritis

NCT02585323 | Completed Results

• 1 other identifier: H15-02038
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

Physical activity is an essential first-line treatment for patients with knee osteoarthritis (OA). However, only 13% of patients meet the activity recommendation of 150 minutes or more per week. The primary goal of this randomized controlled trial is to assess the efficacy of a Fitbit Flex (a wireless physical activity tracking device) paired with a new application, plus a brief education session and telephone counselling by a physiotherapist (PT), to improve physical activity and reduce sedentary time in patients with knee osteoarthritis.

Conditions

Joint Diseases; Knee Osteoarthritis

Keywords

Physical activity; Osteoarthritis; Knee; Exercise; Arthritis

Outcome Measures

Primary Outcomes (1)

• Daily Number of Minutes 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, 13 weeks, 26 weeks, 39 weeks

Secondary Outcomes (15)

• Daily Number of Sedentary Minutes

  Baseline, 13 weeks, 26 weeks, 39 weeks

• Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom

  Baseline, 13 weeks, 26 weeks, 39 weeks

• Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain

  Baseline, 13 weeks, 26 weeks, 39 weeks

• Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation

  Baseline, 13 weeks, 26 weeks, 39 weeks

• Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living

  Baseline, 13 weeks, 26 weeks, 39 weeks

Study Arms (2)

Immediate Intervention Group

ACTIVE COMPARATOR

Education session, Fitbit/FitViz, PT counselling: Participants receive this intervention in Months 1-3. The session will include a presentation on physical activity, an individual goal-setting session with a registered physiotherapist, and an orientation to the Fitbit Flex and the FitViz app. In Months 1 and 2, participants will use the Fitbit/FitViz. The PT will review the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities. In Month 3, participants will continue using the Fitbit/FitViz and have access to a PT via email as needed, but no bi-weekly phone calls. In Months 4-9, participants may continue using the Fitbit/FitViz without access to a PT.

Behavioral: Education session, Fitbit/FitViz, PT counselling

Delayed Intervention Group

PLACEBO COMPARATOR

Same intervention with a 3 month delay: The full intervention will be initiated in Month 4 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physiotherapist. In Months 6-9, participants will continue using Fitbit/FitViz without the PT phone calls.

Behavioral: Same intervention with a 3 month delay

Interventions

Education session, Fitbit/FitViz, PT 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 Intervention Group

Same intervention with a 3 month delay BEHAVIORAL

The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 3 month delay.

Delayed Intervention 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 knee osteoarthritis OR are both 1) over 50, and 2) have experienced 4 weeks of pain, aching, or discomfort in or around the knee during the last year (equal to or more than 28 separate or consecutive days).
• Have no previous diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis), connective tissue diseases, or gout.
• Have no history of using disease-modifying anti-rheumatic drugs, such as hydroxychloroquine, sulfasalazine, methotrexate, biologic agents (e.g., Humira, Enbrel), or gout medications.
• Have no prior knee arthroplasty, and not on a waiting list for total knee replacement surgery.
• Have no history of acute injury to the knee in the past 6 months.
• Have not had surgery in the back, hip, knee, or ankle joints in the past 12 months.
• Have an email address and use online/mobile applications.
• Are able to attend one 1.5-hour education session.

You may not qualify if:

• Have received a hyaluronate injection in a knee in the last 6 months.
• Have received a steroid injection in a knee in the last 6 months.
• Are at risk when exercising, as identified by the Physical Activity Readiness Questionnaire.

Sponsors & Collaborators

• University of British Columbia: lead
• Simon Fraser University: collaborator
• Arthritis Research Centre of Canada: collaborator
• Fraser Health: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Vancouver Coastal Health Research Institute: collaborator

Study Sites (2)

Arthritis Research Canada

Vancouver, British Columbia, V5Y 3P2, Canada

Location

Arthritis Research Canada

Vancouver, British Columbia, V6X 2C7, Canada

Location

Related Publications (1)

• Li LC, Feehan LM, Xie H, Lu N, Shaw CD, Gromala D, Zhu S, Avina-Zubieta JA, Hoens AM, Koehn C, Tam J, Therrien S, Townsend AF, Noonan G, Backman CL. Effects of a 12-Week Multifaceted Wearable-Based Program for People With Knee Osteoarthritis: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 3;8(7):e19116. doi: 10.2196/19116.

  PMID: 32618578 RESULT

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis, Knee; Motor Activity; Osteoarthritis; Arthritis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Limitations and Caveats

With the use of a delay-control design in which the participants in the control arm received the program after a 13-week delay, the efficacy of the program could only be unequivocally assessed at 13 weeks. The results may not be generalizable to men because 82% 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: October 21, 2015
• First Posted: October 23, 2015
• Study Start: April 1, 2017
• Primary Completion: August 21, 2019
• Study Completion: August 26, 2019
• Last Updated: October 6, 2025
• Results First Posted: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)