Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee OA (TRACK-OA)
29 października 2019 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Rzeczywisty)
34
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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British Columbia
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Richmond, British Columbia, Kanada, V6X 2C7
- Arthritis Research Canada
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: 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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Komparator placebo: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Time Spent in Sedentary Behavior
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Linda Li, PT, PhD, Arthritis Research Canada; University of British Columbia
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 stycznia 2015
Zakończenie podstawowe (Rzeczywisty)
1 czerwca 2015
Ukończenie studiów (Rzeczywisty)
1 czerwca 2015
Daty rejestracji na studia
Pierwszy przesłany
8 grudnia 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 grudnia 2014
Pierwszy wysłany (Oszacować)
10 grudnia 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
19 listopada 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
29 października 2019
Ostatnia weryfikacja
1 września 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- H14-02631
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Nie
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .