ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02315664
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02315664
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : July 14, 2017
Sponsor:
Collaborators:
Simon Fraser University
Arthritis Research Centre of Canada
Vancouver General Hospital
Information provided by (Responsible Party):
Linda Li, University of British Columbia

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 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Joint Diseases Behavioral: Education session, Fitbit Flex, and remote coaching by a PT Behavioral: Same intervention with a 2 month delay Not Applicable

Detailed Description:

This project will address the Research Question: Can a non-intrusive physical activity tracking tool, combined with a group education session and advice from a physiotherapist (PT), increase physical activity in patients with knee osteoarthritis (OA)? The investigators focus on knee OA because it is common (affecting 1 in 10) and can be debilitating. Being physically active improves pain, mobility and quality of life; however, less than half of patients are active. Combining the best evidence in OA care and digital technology, the investigators propose a new model of care for improving physical activity in patients with OA. Our primary objective is to determine whether a model involving 1) a group education session, 2) the use of Fitbit Flex, a commercially available physical activity tracker, and 3) remote coaching by a PT can improve physical activity and reduce sedentary time in patients with knee OA. This model of care is in line with the goal of Mary Pack Arthritis Program (MPAP) to optimize activity independence of OA patients with MPAP's available human resources. In this proof-of-concept randomized controlled trial (RCT), the investigators hypothesize that compared to a control group (i.e. the Delayed Intervention group), participants in the Immediate Intervention Group will 1) increase moderate/vigorous physical activity (MVPA), 2) reduce sedentary time, 3) improve in OA disease status, and 4) improve in their self-efficacy of OA management, 4) To examine whether individuals in the Intervention Group will show improved cognitive function over the intervention period compared to the control group, and 5) To examine the pre-intervention factors that predict the degree to which individuals in the Intervention Group increase MVPA and reduce sedentary time.

The investigators will use a mixed-methods approach, involving a RCT and in-depth interviews. The proof-of-concept study will employ a stepped wedge RCT design, whereby the intervention will be sequentially rolled out to participants over a number of time periods. The order in which individuals receive the intervention will be determined at random. The strength of this design is that it can properly address the efficacy question, while avoiding the dilemma of withholding the intervention to some participants, as in a parallel group design.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Physical Activity Using an Online Monitoring Tool: a New Model of Care for Knee Osteoarthritis
Actual Study Start Date : November 2, 2015
Actual Primary Completion Date : May 17, 2017
Actual Study Completion Date : May 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Intervention Group
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 and 2. At the end of the education session, the PT will help participants set personal activity goals. In Month 1 and 2, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will keep the Fitbit and continue to use it with access to a PT via email as needed. In addition, they will receive a monthly e-newsletter about arthritis research that is not related to physical activity.
Behavioral: Education session, Fitbit Flex, and remote coaching by a PT
Participants will receive a brief education session, use of a commercially available physical activity tracker called Fitbit Flex, and remote counseling by a PT. Intervention will be received immediately.

Experimental: Delayed Intervention Group
Same intervention with a 2 month delay: The Delayed Intervention Group (control group) will receive the same monthly e-newsletter in Months 1-2. The full intervention will be initiated in Month 3 with a brief education session, use of Fitbit Flex, and counseling by a physiotherapist. In Month 4, they will continue the intervention without the PT phone calls. Participants will keep the Fitbit for Month 5-6, and have email access to PT as needed.
Behavioral: Same intervention with a 2 month delay
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 month delay.




Primary Outcome Measures :
  1. Time spent in Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Change from baseline in time spent in MVPA at 2 months, 4 months, and 6 months. ]
    Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, and Months 2, 4, and 6. We will calculate the average daily MVPA accumulated in bouts per day. A bout is defined as > 10 consecutive minutes at the level of 3 or higher METs, with allowance for interruption of up to 1 minute below the threshold.


Secondary Outcome Measures :
  1. Time spent in sedentary behaviors [ Time Frame: Change from baseline in time spent sedentary behaviors at 2 months, 4 months, and 6 months. ]
    We will calculate the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of > 20 minutes during waking hours.

  2. Knee Injury and OA Outcome Score (KOOS) [ Time Frame: Change from baseline in knee pain, stiffness, daily activity, sport/recreation, and quality of life at 2 months, 4 months, and 6 months. ]
    The KOOS consists of five subscales: knee pain, stiffness, daily activity, sports/recreation, and quality of life.

  3. Partners in Health Scale [ Time Frame: Baseline, Months 2, 4, and 6 ]
    The Partners in Health Scale is a 12-item measure designed to assess self-efficacy, knowledge of health conditions and treatment, and self-management behaviors such as adopting a healthy lifestyle.

  4. Cognitive Function assessment [ Time Frame: Change from baseline in cognitive functioning at 2 months, 4 months, and 6 months. ]
    Cognitive functioning will be assessed with computer-based tasks: Kirby tasks, Stroop task, list-sorting task, and picture sequence memory test.

  5. Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline ]
    The MoCA is a one-page 30-point test that assesses the following cognitive domains: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation.

  6. Community Health Activities Model Program for Seniors (CHAMPS) [ Time Frame: Change from baseline in physical activity at 2 months, 4 months, and 6 months. ]
    The CHAMPS questionnaire asks participants about their current engagement in 40 different activities including household chores, recreational chores, and leisure and social activities.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315664


Locations
Canada, British Columbia
Arthritis Research Canada
Richmond, British Columbia, Canada, V6X 2C7
Sponsors and Collaborators
University of British Columbia
Simon Fraser University
Arthritis Research Centre of Canada
Vancouver General Hospital
Investigators
Principal Investigator: Linda Li, PhD Arthritis Research Canada

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Linda Li, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02315664     History of Changes
Other Study ID Numbers: H14-01762
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Linda Li, University of British Columbia:
Physical activity
Exercise
Osteoarthritis
Knee
Arthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases