N/A
N=34
Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee OA
Knee Osteoarthritis · Joint Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02313506 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) — 41.3; 66.5; 64.2; 56.0 Minutes per day — p=0.02
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 1 month delay (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) |
41.3; 66.5; 64.2; 56.0; 67.7; 81.9 | 0.02 sig |
| SECONDARY Time Spent in Sedentary Behavior |
548.4; 453.3; 524.9; 492.8; 523.9; 393.1 | — |
| SECONDARY KOOS - Symptoms |
70.6; 70.4; 68.3; 66.8; 72.5; 73.2 | — |
| SECONDARY KOOS - Pain |
74.5; 68.6; 71.4; 71.6; 79.1; 74 | — |
| SECONDARY KOOS - Activities of Daily Living |
81.8; 78.3; 75.1; 79.1; 83; 82.2 | — |
| SECONDARY KOOS - Sport and Recreation Function |
55.6; 51.2; 54.7; 54.4; 64.4; 55.6 | — |
| SECONDARY KOOS - Knee-related Quality of Life |
53.3; 47.4; 51.8; 48.9; 56.6; 52.3 | — |
| SECONDARY Partners in Health Scale |
21.9; 26.8; 17.2; 31.9; 21.6; 22.9 | — |
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 pilot randomized controlled trail is to assess the feasibility and preliminary efficacy of a multi-component intervention/model of care involving a group education session, use of the Fitbit Flex (a wireless physical activity tracking device), and weekly telephone counselling by a physiotherapist (PT) to improve physical activity and reduce sedentary time in patients with knee OA.
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 2-hour education session at the Mary Pack Arthritis Centre.
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)
Data sourced from ClinicalTrials.gov (NCT02313506). 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.