Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee OA (TRACK-OA)
2019년 10월 29일 업데이트: Linda Li, University of British Columbia
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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
34
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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British Columbia
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Richmond, British Columbia, 캐나다, V6X 2C7
- Arthritis Research Canada
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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.
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.
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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.
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위약 비교기: Delayed Intervention Group
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.
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The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
기간: Baseline; 1 month and 2 months from baseline
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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.
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Baseline; 1 month and 2 months from baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time Spent in Sedentary Behavior
기간: Baseline; 1 month and 2 months from baseline
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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.
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Baseline; 1 month and 2 months from baseline
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KOOS - Symptoms
기간: Baseline; 1 month and 2 months from baseline
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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.
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Baseline; 1 month and 2 months from baseline
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KOOS - Pain
기간: Baseline; 1 month and 2 months from baseline
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Pain was measured by a Knee Injury and Osteoarthritis Outcome Score subscale.
Scores range from 0 to 100, with higher being better.
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Baseline; 1 month and 2 months from baseline
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KOOS - Activities of Daily Living
기간: Baseline; 1 month and 2 months from baseline
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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.
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Baseline; 1 month and 2 months from baseline
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KOOS - Sport and Recreation Function
기간: Baseline; 1 month and 2 months from baseline
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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.
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Baseline; 1 month and 2 months from baseline
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KOOS - Knee-related Quality of Life
기간: Baseline; 1 month and 2 months from baseline
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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.
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Baseline; 1 month and 2 months from baseline
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Partners in Health Scale
기간: Baseline; 1 month and 2 months from baseline
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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.
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Baseline; 1 month and 2 months from baseline
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Linda Li, PT, PhD, Arthritis Research Canada; University of British Columbia
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 1월 1일
기본 완료 (실제)
2015년 6월 1일
연구 완료 (실제)
2015년 6월 1일
연구 등록 날짜
최초 제출
2014년 12월 8일
QC 기준을 충족하는 최초 제출
2014년 12월 9일
처음 게시됨 (추정)
2014년 12월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 11월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 29일
마지막으로 확인됨
2019년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .