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Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee OA (TRACK-OA)

29. Oktober 2019 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

34

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • British Columbia
      • Richmond, British Columbia, Kanada, V6X 2C7
        • Arthritis Research Canada

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Verhalten: 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 (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
Placebo-Komparator: 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.
Verhalten: Same intervention with a 1 month delay
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time Spent in Sedentary Behavior
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of British Columbia

Mitarbeiter

Vancouver General Hospital
Arthritis Research Centre of Canada

Ermittler

  • Hauptermittler: Linda Li, PT, PhD, Arthritis Research Canada; University of British Columbia

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2015

Primärer Abschluss (Tatsächlich)

1. Juni 2015

Studienabschluss (Tatsächlich)

1. Juni 2015

Studienanmeldedaten

Zuerst eingereicht

8. Dezember 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Dezember 2014

Zuerst gepostet (Schätzen)

10. Dezember 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. November 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Oktober 2019

Zuletzt verifiziert

1. September 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H14-02631

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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