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

Leanne Hassett; Anne Tiedemann; Rana S Hinman; Maria Crotty; Tammy Hoffmann; Lisa Harvey; Nicholas F Taylor; Colin Greaves; Daniel Treacy; Matthew Jennings; Andrew Milat; Kim L Bennell; Kirsten Howard; Maayken van den Berg; Marina Pinheiro; Siobhan Wong; Catherine Kirkham; Elizabeth Ramsay; Sandra O'Rourke; Catherine Sherrington

doi:10.1136/bmjopen-2019-034696

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

BMJ Open. 2020 Nov 3;10(11):e034696. doi: 10.1136/bmjopen-2019-034696.

Authors

Leanne Hassett^{1

2

3}, Anne Tiedemann^{1

3}, Rana S Hinman⁴, Maria Crotty⁵, Tammy Hoffmann⁶, Lisa Harvey⁷, Nicholas F Taylor⁸, Colin Greaves⁹, Daniel Treacy^{1

3

10}, Matthew Jennings¹¹, Andrew Milat^{3

12}, Kim L Bennell⁴, Kirsten Howard³, Maayken van den Berg¹³, Marina Pinheiro^{1

2

3}, Siobhan Wong^{1

3}, Catherine Kirkham^{1

3}, Elizabeth Ramsay^{1

3}, Sandra O'Rourke^{1

3}, Catherine Sherrington^{14

3}

Affiliations

¹ Institute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia.
² Discipline of Physiotherapy, Sydney School of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.
³ School of Public Health, University of Sydney, Camperdown, New South Wales, Australia.
⁴ Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia.
⁵ College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
⁶ Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia.
⁷ John Walsh Centre for Rehabilitation Research, Northern Clinical School, The University of Sydney, St Leonards, New South Wales, Australia.
⁸ School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, New South Wales, Australia.
⁹ School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.
¹⁰ Prince of Wales Hospital, South Eastern Sydney Local Health District, Sydney, New South Wales, Australia.
¹¹ Liverpool Hospital, South Western Sydney Local Health District, Sydney, New South Wales, Australia.
¹² NSW Ministry of Health, Liverpool, New South Wales, Australia.
¹³ College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia.
¹⁴ Institute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia cathie.sherrington@sydney.edu.au.

Abstract

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.

Keywords: clinical trials; geriatric medicine; rehabilitation medicine.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Accidental Falls*
Exercise*
Fear
Humans
Mentoring*
Quality of Life