N/A N=61 Randomized Single-blind Supportive Care

MONITOR-OA: Using Wearable Activity Trackers to Improve Physical Activity in Knee Osteoarthritis

Knee Osteoarthritis · Joint Diseases

Bottom Line

View on ClinicalTrials.gov: NCT02315664 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) — 62.1; 65.3; 75.5; 50.0 Minutes per day

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Education session, Fitbit Flex, and remote coaching by a PT (Behavioral); Same intervention with a 2 month delay (Behavioral)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University of British Columbia
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)	62.1; 65.3; 75.5; 50.0; 62.6; 60.1	—
SECONDARY Time Spent in Sedentary Behaviors	464.1; 497.4; 437.6; 503.0; 505.9; 508.9	—
SECONDARY KOOS - Symptoms	59.8; 62.9; 62.6; 61.7; 62.4; 63.4	—
SECONDARY KOOS - Pain	66.2; 65.1; 70.9; 64.8; 67.5; 66.3	—
SECONDARY KOOS - Activity of Daily Living	71.8; 74.1; 76; 71; 76.6; 75.2	—
SECONDARY KOOS - Sports & Recreation	47.3; 52.7; 49.3; 47; 50; 48.9	—
SECONDARY KOOS - Quality of Life	41; 44.6; 47.2; 42.4; 45.4; 47.5	—
SECONDARY Partners in Health Scale	18.4; 20.5; 14.9; 18.3; 14.3; 14.9	—

Summary

Physical activity is an essential first-line treatment for patients with knee osteoarthritis (OA). However, a 2013 systematic review found only 13% met the activity recommendation of 150 minutes or more per week. The primary goal of this randomized controlled trail is to assess the efficacy of a physical activity counseling model, involving a group education session, the use of Fitbit Flex (a wireless physical activity tracking device), and online/telephone coaching by a physiotherapist (PT), to improve physical activity and reduce sedentary time in patients with knee OA. Engaging in regular physical activity can have the additional benefit of improving cognitive functioning.

Eligibility Criteria

Inclusion Criteria

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 rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica, connective tissue diseases, fibromyalgia or gout.
Have no history of using disease-modifying anti-rheumatic drugs or gout medications.
Have no prior knee replacement surgery, 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, foot or ankle joints in the past 12 months.
Have an email address and daily access to a computer with internet connection.
Be able to attend a 1.5-hour education session at the Mary Pack Arthritis Centre.
Be able to attend a 1-hour assessment session at Vancouver General Hospital prior to beginning the study, and again 2 and 4 months later.

In addition, participants may be eligible (not required) to partake in a brain magnetic resonance imaging (MRI) assessment if they:

Do not have a pacemaker, brain aneurysm clip, cochlear implant, electrical stimulator for nerves or bones, implanted infusion pump, artificial heart valve, orthopaedic hardware, other metallic prostheses, coil, catheter or filter in any blood vessel, ear or eye implant, bullets or other metallic fragments.
Do not have a history of any eye injury involving metal fragments.
Do not have a history of claustrophobia (i.e. fearful of being in closed or narrow spaces).
Have not had surgery or tattoos within the past 6 weeks.
Are able to attend a 1-hour session at the UBC 3T Magnetic Resonance Imaging Centre (2221 Wesbrook Mall, Vancouver).

Exclusion Criteria

Have a body mass index of equal to or greater than 40
Have received a steroid injection in a knee in the last 6 months
Have received a hyaluronate injection in a knee in the last 6 months
Use medication that may impair activity tolerance (e.g. beta blockers)
Are at risk when exercising, as identified by the Physical Activity Readiness Questionnaire (PAR-Q)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02315664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.