Knee OsteoarthritisTRACK-OANCT02313506
Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee OA
A study testing Education session, Fitbit Flex, and remote coaching by a PT and Same intervention with a 1 month delay in people with Knee Osteoarthritis and Joint Diseases, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis, Joint Diseases
- What is being tested?
- Education session, Fitbit Flex, and remote coaching by a PT and Same intervention with a 1 month delay
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Preliminary Efficacy of an Activity Tracker-driven Intervention for Promoting Physical Activity in People Living With Osteoarthritis of the Knee
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.
Read the detailed description
Knee osteoarthritis (OA) is common (affecting 1 in 10), painful, and debilitating. Being physically active improves pain, mobility and quality of life for people living with knee OA; 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.
The investigators primary objective is to determine the feasibility and preliminary efficacy of a multi-component model of care involving 1) a group education and structured goal-setting session, 2) the use of Fitbit Flex (a commercially available physical activity tracker) and 3) weekly telephone activity counselling by a physiotherapist for improving physical activity and reducing sedentary time in patients with knee OA.
In this pilot randomized controlled trial 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 OA disease status, and 4) improve abilities to self-manage their condition.
- Conditions
- Knee Osteoarthritis, Joint Diseases
- Being tested
- Education session, Fitbit Flex, and remote coaching by a PT, Same intervention with a 1 month delay
- Keywords
- Physical activity, Exercise, Osteoarthritis, Knee, Arthritis
- Medical subject headings
- Osteoarthritis, Knee, Joint Diseases, Motor Activity, Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education session, Fitbit Flex, and remote coaching by a PTBehavioural
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.
Same intervention with a 1 month delayBehavioural
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Same intervention with a 1 month delay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; 1 month and 2 months from baseline
Secondary outcomes (7)
Time Spent in Sedentary Behavior
We calculated the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of > 20 minutes during waking hours.
Measured: Baseline; 1 month and 2 months from baseline
KOOS - Symptoms
Symptoms were measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Measured: Baseline; 1 month and 2 months from baseline
KOOS - Pain
Pain was measured by a Knee Injury and Osteoarthritis Outcome Score subscale. Scores range from 0 to 100, with higher being better.
Measured: Baseline; 1 month and 2 months from baseline
KOOS - Activities of Daily Living
Activities of Daily Living was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Measured: Baseline; 1 month and 2 months from baseline
KOOS - Sport and Recreation Function
Sport and Recreation Function was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Measured: Baseline; 1 month and 2 months from baseline
KOOS - Knee-related Quality of Life
Quality of life was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Measured: Baseline; 1 month and 2 months from baseline
Partners in Health Scale
The Partners in Health Scale is a 12-item measure designed to assess disease self-management abilities including knowledge of health conditions, ability to participate in decision-making with health care professionals, and ability to pursue a healthy lifestyle. Scores range from 0 to 96, with lower being better.
Measured: Baseline; 1 month and 2 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study used a delayed control design.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Research Centre of Canada, Vancouver General Hospital
- Responsible party
- Principal investigator, Linda Li, University of British Columbia
- Investigators
- Linda Li, PT, PhD, Principal investigator, Arthritis Research Canada; University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313506
- Sponsor's protocol ID
- H14-02631
- Acronym
- TRACK-OA
- Status last verified
- Sep 2019
- First submitted
- 8 Dec 2014
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28652228Clayton 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.
PubMed 27965808
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of an Activity Tracker-driven Intervention for Promoting Physical Activity in People Living With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02313506
- Acronym / sponsor ID
- TRACK-OA / H14-02631
- Conditions
- Knee Osteoarthritis, Joint Diseases
- Keywords
- Physical activity, Exercise, Osteoarthritis, Knee, Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Arthritis Research Centre of Canada, Vancouver General Hospital
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Dec 2014 (estimated)
- Results
- Posted 19 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Knee osteoarthritis (OA) is common (affecting 1 in 10), painful, and debilitating. Being physically active improves pain, mobility and quality of life for people living with knee OA; 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.
The investigators primary objective is to determine the feasibility and preliminary efficacy of a multi-component model of care involving 1) a group education and structured goal-setting session, 2) the use of Fitbit Flex (a commercially available physical activity tracker) and 3) weekly telephone activity counselling by a physiotherapist for improving physical activity and reducing sedentary time in patients with knee OA.
In this pilot randomized controlled trial 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 OA disease status, and 4) improve abilities to self-manage their condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study used a delayed control design.
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Group | Active comparator | Behavioral: Education session, Fitbit Flex, and remote coaching by a PTEducation 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. |
| Delayed Intervention Group | Placebo comparator | Behavioral: Same intervention with a 1 month delaySame 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education session, Fitbit Flex, and remote coaching by a PTParticipants 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. | Behavioural | Immediate Intervention Group |
| Same intervention with a 1 month delayThe Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay. | Behavioural | Delayed Intervention Group |
Primary outcome
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
Time frame: Baseline; 1 month and 2 months from baseline
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.
7 secondary outcomes
Time Spent in Sedentary Behavior
Time frame: Baseline; 1 month and 2 months from baseline
KOOS - Symptoms
Time frame: Baseline; 1 month and 2 months from baseline
KOOS - Pain
Time frame: Baseline; 1 month and 2 months from baseline
KOOS - Activities of Daily Living
Time frame: Baseline; 1 month and 2 months from baseline
KOOS - Sport and Recreation Function
Time frame: Baseline; 1 month and 2 months from baseline
KOOS - Knee-related Quality of Life
Time frame: Baseline; 1 month and 2 months from baseline
Partners in Health Scale
Time frame: Baseline; 1 month and 2 months from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28652228Li 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.
- Derived from this study: PubMed 27965808Clayton 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.
- Study webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Li, PT, PhD principal investigator
Arthritis Research Canada; University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education session, Fitbit Flex, and remote coaching by a PT and Same intervention with a 1 month delay in people with Knee Osteoarthritis and Joint Diseases, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) (time frame: Baseline; 1 month and 2 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02313506, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.