Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee OA

NCT02313506 | Completed Results

• 1 other identifier: H14-02631
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis; Joint Diseases

Keywords

Physical activity; Exercise; Osteoarthritis; Knee; Arthritis

Outcome Measures

Primary Outcomes (1)

• Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)

  Participants wore a SenseWear Mini device for 7 days at baseline, and Months 1 and 2. We calculated the average time spent in MVPA accumulated in bouts per day. A bout is defined as 10 consecutive minutes or more at the level of 3 or higher METs, with allowance for interruption of up to 1 minute below the threshold.

  Baseline; 1 month and 2 months from baseline

Secondary Outcomes (7)

• Time Spent in Sedentary Behavior

  Baseline; 1 month and 2 months from baseline

• KOOS - Symptoms

  Baseline; 1 month and 2 months from baseline

• KOOS - Pain

  Baseline; 1 month and 2 months from baseline

• KOOS - Activities of Daily Living

  Baseline; 1 month and 2 months from baseline

• KOOS - Sport and Recreation Function

  Baseline; 1 month and 2 months from baseline

Study Arms (2)

Immediate Intervention Group

ACTIVE COMPARATOR

Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.

Behavioral: Education session, Fitbit Flex, and remote coaching by a PT

Delayed Intervention Group

PLACEBO COMPARATOR

Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.

Behavioral: Same intervention with a 1 month delay

Interventions

Education session, Fitbit Flex, and remote coaching by a PT BEHAVIORAL

Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.

Immediate Intervention Group

Same intervention with a 1 month delay BEHAVIORAL

The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay.

Delayed Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), 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 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Arthritis Research Centre of Canada: collaborator
• Vancouver General Hospital: collaborator

Study Sites (1)

Arthritis Research Canada

Richmond, British Columbia, V6X 2C7, Canada

Location

Related Publications (2)

• Li LC, Sayre EC, Xie H, Clayton C, Feehan LM. A Community-Based Physical Activity Counselling Program for People With Knee Osteoarthritis: Feasibility and Preliminary Efficacy of the Track-OA Study. JMIR Mhealth Uhealth. 2017 Jun 26;5(6):e86. doi: 10.2196/mhealth.7863.

  PMID: 28652228 DERIVED

• Clayton C, Feehan L, Goldsmith CH, Miller WC, Grewal N, Ye J, Yoo JY, Li LC. Feasibility and preliminary efficacy of a physical activity counseling intervention using Fitbit in people with knee osteoarthritis: the TRACK-OA study protocol. Pilot Feasibility Stud. 2015 Aug 22;1:30. doi: 10.1186/s40814-015-0027-x. eCollection 2015.

  PMID: 27965808 DERIVED

Related Links

• Study webpage

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Limitations and Caveats

Our sample was physically active at baseline. Also, the majority of our participants were women. Men and women may respond to behavioral interventions differently, but we are unable to examine the effect of sex on the outcomes.

Results Point of Contact

• Title: Dr. Linda Li
• Organization: Arthritis Research Canada

lli@arthritisresearch.ca

604-207-4020

Study Officials

• Linda Li, PT, PhD

  Arthritis Research Canada; University of British Columbia

  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

Model Details: This study used a delayed control design.

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 19, 2019
• Results First Posted: November 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)