Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee OA (TRACK-OA)
29. října 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
34
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
British Columbia
-
Richmond, British Columbia, Kanada, V6X 2C7
- Arthritis Research Canada
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
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.
|
|
Komparátor placeba: 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.
|
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
Časové okno: 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.
|
Baseline; 1 month and 2 months from baseline
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time Spent in Sedentary Behavior
Časové okno: Baseline; 1 month and 2 months from baseline
|
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.
|
Baseline; 1 month and 2 months from baseline
|
|
KOOS - Symptoms
Časové okno: Baseline; 1 month and 2 months from baseline
|
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.
|
Baseline; 1 month and 2 months from baseline
|
|
KOOS - Pain
Časové okno: Baseline; 1 month and 2 months from baseline
|
Pain was measured by a Knee Injury and Osteoarthritis Outcome Score subscale.
Scores range from 0 to 100, with higher being better.
|
Baseline; 1 month and 2 months from baseline
|
|
KOOS - Activities of Daily Living
Časové okno: Baseline; 1 month and 2 months from baseline
|
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.
|
Baseline; 1 month and 2 months from baseline
|
|
KOOS - Sport and Recreation Function
Časové okno: Baseline; 1 month and 2 months from baseline
|
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.
|
Baseline; 1 month and 2 months from baseline
|
|
KOOS - Knee-related Quality of Life
Časové okno: Baseline; 1 month and 2 months from baseline
|
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.
|
Baseline; 1 month and 2 months from baseline
|
|
Partners in Health Scale
Časové okno: Baseline; 1 month and 2 months from baseline
|
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.
|
Baseline; 1 month and 2 months from baseline
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Linda Li, PT, PhD, Arthritis Research Canada; University of British Columbia
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2015
Primární dokončení (Aktuální)
1. června 2015
Dokončení studie (Aktuální)
1. června 2015
Termíny zápisu do studia
První předloženo
8. prosince 2014
První předloženo, které splnilo kritéria kontroly kvality
9. prosince 2014
První zveřejněno (Odhad)
10. prosince 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
19. listopadu 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
29. října 2019
Naposledy ověřeno
1. září 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- H14-02631
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ne
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .