Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial

Introduction Mobility limitation is common and often results from neurological and musculoskeletal health conditions, ageing and/or physical inactivity. In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhanc...

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Main Authors: Kirsten Howard, Anne Tiedemann, Catherine Sherrington, Tammy Hoffmann, Kim L Bennell, Colin Greaves, Rana S Hinman, Nicholas F Taylor, Andrew Milat, Marina Pinheiro, Leanne Hassett, Maria Crotty, Lisa Harvey, Daniel Treacy, Matthew Jennings, Maayken van den Berg, Siobhan Wong, Catherine Kirkham, Elizabeth Ramsay, Sandra O'Rourke
Format: Article
Language:English
Published: BMJ Publishing Group 2020-11-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/11/e034696.full
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author Kirsten Howard
Anne Tiedemann
Catherine Sherrington
Tammy Hoffmann
Kim L Bennell
Colin Greaves
Rana S Hinman
Nicholas F Taylor
Andrew Milat
Marina Pinheiro
Leanne Hassett
Maria Crotty
Lisa Harvey
Daniel Treacy
Matthew Jennings
Maayken van den Berg
Siobhan Wong
Catherine Kirkham
Elizabeth Ramsay
Sandra O'Rourke
author_facet Kirsten Howard
Anne Tiedemann
Catherine Sherrington
Tammy Hoffmann
Kim L Bennell
Colin Greaves
Rana S Hinman
Nicholas F Taylor
Andrew Milat
Marina Pinheiro
Leanne Hassett
Maria Crotty
Lisa Harvey
Daniel Treacy
Matthew Jennings
Maayken van den Berg
Siobhan Wong
Catherine Kirkham
Elizabeth Ramsay
Sandra O'Rourke
author_sort Kirsten Howard
collection DOAJ
description Introduction Mobility limitation is common and often results from neurological and musculoskeletal health conditions, ageing and/or physical inactivity. In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations. Both are based on behaviour change theories and involve tailored advice from physiotherapists.Methods and analysis This pragmatic hybrid effectiveness-implementation type 1 randomised control trial (n=600) will be undertaken among adults with self-reported mobility limitations. It aims to estimate the effects on physical activity of: (1) an enhanced 6-month intervention package (one face-to-face physiotherapy assessment, tailored physical activity plan, physical activity phone coaching from a physiotherapist, informational/motivational resources and activity monitors) compared with a less intensive 6-month intervention package (single session of tailored phone advice from a physiotherapist, tailored physical activity plan, unidirectional text messages, informational/motivational resources); (2) the enhanced intervention package compared with no intervention (6-month waiting list control group); and (3) the less intensive intervention package compared with no intervention (waiting list control group). The primary outcome will be average steps per day, measured with the StepWatch Activity Monitor over a 1-week period, 6 months after randomisation. Secondary outcomes include other physical activity measures, measures of health and functioning, individualised mobility goal attainment, mental well-being, quality of life, rate of falls, health utilisation and intervention evaluation. The hybrid effectiveness-implementation design (type 1) will be used to enable the collection of secondary implementation outcomes at the same time as the primary effectiveness outcome. An economic analysis will estimate the cost-effectiveness and cost-utility of the interventions compared with no intervention and to each other.Ethics and dissemination Ethical approval has been obtained by Sydney Local Health District, Royal Prince Alfred Zone. Dissemination will be via publications, conferences, newsletters, talks and meetings with health managers.Trial registration number ACTRN12618001983291.
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spelling doaj-art-4c6ca6870cf548e4933977a6fbd8adf82025-08-20T02:07:45ZengBMJ Publishing GroupBMJ Open2044-60552020-11-01101110.1136/bmjopen-2019-034696Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trialKirsten Howard0Anne Tiedemann1Catherine Sherrington2Tammy Hoffmann3Kim L Bennell4Colin Greaves5Rana S Hinman6Nicholas F Taylor7Andrew Milat8Marina Pinheiro9Leanne Hassett10Maria Crotty11Lisa Harvey12Daniel Treacy13Matthew Jennings14Maayken van den Berg15Siobhan Wong16Catherine Kirkham17Elizabeth Ramsay18Sandra O'Rourke199 Menzies Centre for Health Policy and Economics, University of Sydney, Sydney, New South Wales, Australia1 The University of Sydney Institute for Musculoskeletal Health, Sydney, New South Wales, AustraliaInstitute for Musculoskeletal Health, University of Sydney, Sydney, New South Wales, Australiaprofessor10 Department of Physiotherapy, Faculty of Medicine Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia3 School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UKCentre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Melbourne, Victoria, AustraliaCollege of Science, Health and Engineering, La Trobe University, Bundoora, Victoria, AustraliaThe University of Sydney School of Public Health, Sydney, New South Wales, AustraliaUniversity of Sydney, Sydney, New South Wales, Australia1 Sydney Musculoskeletal Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, AustraliaCollege of Medicine and Public Health, Flinders University, Flinders University, Adelaide, South Australia, AustraliaJohn Walsh Centre for Rehabilitation Research, Northern Clinical School, The University of Sydney, St Leonards, New South Wales, AustraliaInstitute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, AustraliaPhysiotherapy, Liverpool Hospital, Liverpool, New South Wales, AustraliaCollege of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, AustraliaInstitute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia1 Sydney Musculoskeletal Health, The University of Sydney, Sydney, New South Wales, AustraliaInstitute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, AustraliaInstitute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, AustraliaIntroduction Mobility limitation is common and often results from neurological and musculoskeletal health conditions, ageing and/or physical inactivity. In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations. Both are based on behaviour change theories and involve tailored advice from physiotherapists.Methods and analysis This pragmatic hybrid effectiveness-implementation type 1 randomised control trial (n=600) will be undertaken among adults with self-reported mobility limitations. It aims to estimate the effects on physical activity of: (1) an enhanced 6-month intervention package (one face-to-face physiotherapy assessment, tailored physical activity plan, physical activity phone coaching from a physiotherapist, informational/motivational resources and activity monitors) compared with a less intensive 6-month intervention package (single session of tailored phone advice from a physiotherapist, tailored physical activity plan, unidirectional text messages, informational/motivational resources); (2) the enhanced intervention package compared with no intervention (6-month waiting list control group); and (3) the less intensive intervention package compared with no intervention (waiting list control group). The primary outcome will be average steps per day, measured with the StepWatch Activity Monitor over a 1-week period, 6 months after randomisation. Secondary outcomes include other physical activity measures, measures of health and functioning, individualised mobility goal attainment, mental well-being, quality of life, rate of falls, health utilisation and intervention evaluation. The hybrid effectiveness-implementation design (type 1) will be used to enable the collection of secondary implementation outcomes at the same time as the primary effectiveness outcome. An economic analysis will estimate the cost-effectiveness and cost-utility of the interventions compared with no intervention and to each other.Ethics and dissemination Ethical approval has been obtained by Sydney Local Health District, Royal Prince Alfred Zone. Dissemination will be via publications, conferences, newsletters, talks and meetings with health managers.Trial registration number ACTRN12618001983291.https://bmjopen.bmj.com/content/10/11/e034696.full
spellingShingle Kirsten Howard
Anne Tiedemann
Catherine Sherrington
Tammy Hoffmann
Kim L Bennell
Colin Greaves
Rana S Hinman
Nicholas F Taylor
Andrew Milat
Marina Pinheiro
Leanne Hassett
Maria Crotty
Lisa Harvey
Daniel Treacy
Matthew Jennings
Maayken van den Berg
Siobhan Wong
Catherine Kirkham
Elizabeth Ramsay
Sandra O'Rourke
Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial
BMJ Open
title Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial
title_full Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial
title_fullStr Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial
title_full_unstemmed Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial
title_short Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial
title_sort physical activity coaching for adults with mobility limitations protocol for the comeback pragmatic hybrid effectiveness implementation type 1 randomised controlled trial
url https://bmjopen.bmj.com/content/10/11/e034696.full
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