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Coaching and Exercise for Better Walking (ComeBACK) trial

Physical activity coaching for adults with mobility limitations: a pragmatic randomised controlled trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001983291
Acronym
ComeBACK
Enrollment
512
Registered
2018-12-10
Start date
2019-02-13
Completion date
2023-01-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Mobility limitation is a particularly common and serious form of physical disability due to neurological, musculoskeletal health conditions, ageing and/or physical inactivity. Physical activity prescription in people with mobility limitations is complex so we hypothesise that tailored advice from physiotherapists will enhance activity levels. This pragmatic trial (n=600) aims to establish the effects on measured physical activity among adults with self-reported mobility limitations of: i). an enhanced intervention package (one face-to-face or video conference assessment, tailored physical activity plan, physical activity phone coaching supported with activity monitors and on-line website resources) compared with a less intensive intervention package (single session of tailored phone advice with website on-line resources and text messages); ii). an enhanced intervention package compared with no intervention; iii). a less intensive intervention package compared with no intervention.

Interventions

ComeBACK is a three arm trial. Intervention group 1: Coaching to ComeBACK; Intervention group 2: Texting to ComeBACK; Intervention group 3: Texting to ComeBACK later (waitlist control). Intervention description using the TIDieR checklist. Why: Over 1 million Australians currently require assistance to, or are unable to, walk about their homes. The impact of mobility limitation is increasing due to population ageing. Physical activity participation has enormous untapped potential as a cost-effe

ComeBACK is a three arm trial. Intervention group 1: Coaching to ComeBACK; Intervention group 2: Texting to ComeBACK; Intervention group 3: Texting to ComeBACK later (waitlist control). Intervention description using the TIDieR checklist. Why: Over 1 million Australians currently require assistance to, or are unable to, walk about their homes. The impact of mobility limitation is increasing due to population ageing. Physical activity participation has enormous untapped potential as a cost-effective approach to enhancing health in people of most ages, health conditions and physical abilities, however most people with mobility limitations are insufficiently active for health benefits. Remote interventions such as telephone health coaching and text-message support to encourage physical activity are scalable interventions which can be tailored to match the individual’s capacity and preferences. Physical activity prescription for people with mobility limitations is complex as they face additional barriers to physical activity participation, thus interventions delivered by a health professional such as a physiotherapist is needed. A theoretical basis combining Self Determination Theory, Social Cognitive Theory and Self Regulation Theory informs the choice of intervention components and behaviour change techniques and underpins all participant materials. Tailoring: Both interventions (Coaching to ComeBACK and Texting to ComeBACK) are tailored for each participant to address their current mobility limitations and physical inactivity, considering participant goals, exercise preferences and contextual factors (e.g. home environment). Group 1: Coaching to ComeBACK What procedures: *Initial physiotherapy assessment to identify mobility status, safety issues, medical, social and environmental influences on mobility. Three-way (participant/health coach/physiotherapist) handover at end of session if possible. * Patient-centred health coaching incorporating behaviour change strategies including goal-setting, problem-solving, building social support, experiential learning and motivational interviewing. What materials: * Study specific evidence-based and theoretically informed education booklet on physical activity, safe mobility and behaviour change. * Access to closed study website designed specifically for this study with 3 components: 1) why be active? 2) how to be active (links to resources); 3) how others do it (video case studies-modelling elements of Social Cognitive Theory). * Physical activity plan shared with General Practitioner. * Option to use activity monitor and/or physical activity apps for self-monitoring. Who provided: * Initial physiotherapy assessment conducted by trained local physiotherapist either employed by the study, paid casually or employed in the local health service. * Health coaching provided by trained physiotherapists employed by the study with clinical experience working with the study population and research experience delivering telephone-based health coaching. Coaches attended courses through Wellness Coaching Australia; HealthChange Australia and Medicoach as well as receiving training by study investigator (CG) in advanced motivational interviewing, a framework for “good (functional) motivation” and intervention techniques. How: * The initial physiotherapy assessment will be conducted face-to-face at the participant’s home or by video conference by a physiotherapist. The three-way handover will be via phone or video conference. * The health coaching will be delivered via telephone. * Education booklet, physical activity plan, access details to website designed specifically for this study and activity monitor (optional) will be mailed to participants. Where: The intervention will be delivered remotely (apart from initial face to face physiotherapy assessment) to community-dwelling people in Australia, initially commencing in the states of New South Wales, South Australia and Victoria. When and how much: * The face-to-face / video conference assessment will occur at the beginning of the intervention period and will last for ~ 1 hour. * The telephone-based health coaching will occur after the face-to-face assessment, at a tailored frequency and duration (approximately every 2 weeks for 20-30 min) for a total duration of 6 months. * The education booklet and access details for specific study website will be mailed prior to initial health coaching session. The physical activity plan and activity monitor (if requested) will be mailed (or emailed) after the initial health coaching session. Groups 2: Texting to ComeBACK What procedures: * One-off tailored advice to provide expert assessment of capability, identifying appropriate physical activity opportunities and to build motivation. * 3-4 times per week (tapering down over time) text messages with some personalisation and tailoring to provide motivation support, planning support, problem-solving and maintenance support. What materials: * Study specific evidence-based and theoretically informed education booklet on physical activity, safe mobility and behaviour change. * Access to closed study specific website with 3 components: 1) why be active? 2) how to be active (links to resources); 3) how others do it (video case studies-modelling elements of Social Cognitive Theory). * Physical activity plan shared with General Practitioner. Who provided: * Tailored advice and personalisation and tailoring of text messages provided by trained physiotherapists employed by the study with clinical experience working with the study population and research experience delivering telephone-based health coaching. Coaches attended courses through Wellness Coaching Australia; HealthChange Australia and Medicoach as well as receiving training by study investigator (CG) in advanced motivational interviewing, a framework for “good (functional) motivation” and intervention techniques. How: * The tailored advice will be delivered via telephone. * Text messages will be pre-scheduled using a web-based short message service to be delivered to the participant’s mobile phone. * Education booklet, physical activity plan and access details to website will be mailed to participants. Where: * The intervention will be delivered remotely to community-dwelling people in Australia, initially commencing in the states of New South Wales, South Australia and Victoria. When and how much: * The one-off tailored advice session will occur at the beginning of the intervention period and will last for ~ 1 hour (this could be broken into two calls if the participant fatigues or has limited time). * The text messages will be pre-scheduled after the advice session to enable tailoring to the participants’ needs and preferences. They will be delivered 3-4x per week (tapering down over time) for 6 months with opt out feature and option to increase or decrease frequency after 1 month. * The education booklet and access details for study specific website will be mailed prior to health coaching session. The physical activity plan will be mailed (or emailed) after the advice session. and Group 3 Texting to ComeBACK later (delayed start) 0-26 weeks post randomisation no study intervention or resources available from 26 weeks onwards (6 months post randomisation start) What procedures: * One-off tailored advice to provide expert assessment of capability, identifying appropriate physical activity opportunities and to build motivation. * 3-4 times per week (tapering down over time) text messages with some personalisation and tailoring to provide motivation support, planning support, problem-solving and maintenance support. What materials: * Study specific evidence-based and theoretically informed education booklet on physical activity, safe mobility and behaviour change. * Access to closed study designed website with 3 components: 1) why be active? 2) how to be active (links to resources); 3) how others do it (video case studies-modelling elements of Social Cognitive Theory). * Physical activity plan shared with General Practitioner. Who provided: * Tailored advice and personalisation and tailoring of text messages provided by trained physiotherapists employed by the study with clinical experience working with the study population and research experience delivering telephone-based health coaching. Coaches attended courses through Wellness Coaching Australia; HealthChange Australia and Medicoach as well as receiving training by study investigator (CG) in advanced motivational interviewing, a framework for “good (functional) motivation” and intervention techniques. How: * The tailored advice will be delivered via telephone. * Text messages will be pre-scheduled using a web-based short message service to be delivered to the participant’s mobile phone. * Education booklet, physical activity plan and access details to closed study designed website will be mailed to participants. Where: * The intervention will be delivered remotely to community-dwelling people in Australia, initially commencing in the states of New South Wales, South Australia and Victoria. When and how much: * The one-off tailored advice session will occur at the beginning of the intervention period (6 months after randomisation (delayed start) and will last for ~ 1 hour (this could be broken into two calls if the participant fatigues or has limited time). * The text messages will be pre-scheduled after the advice session to enable tailoring to the participants’ needs and preferences. They will be delivered 3-4 times per week (tapering down over time) for 6 months with opt out feature and option to increase or decrease frequency after 1 month. * The education booklet and access details for study specific designed website will be mailed prior to health coaching session. The physical activity plan will be mailed after the advice session

Sponsors

The University Of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The trial will involve consenting adults who are: • male or female; • 18 + years; • living in the community; • are able to leave their home without physical assistance from another person (but may use a walking aid); • have a mobility limitation (self-reported difficulty or inability to walk 800m); • without major cognitive impairment (diagnosis of dementia or a Memory Impairment Screen score < 5); • have sufficient hearing and english language skills for a phone-based intervention;

Exclusion criteria

Update The trial will exclude adults who are: • residents of residential aged care facilities; • have the following medical conditions: delirium, acute medical illnesses, severe psychiatric disorders, rapidly progressive neurological diseases; • have a major cognitive impairment (a diagnosis of dementia or a Memory Impairment Screen score of less than 5); • currently undertaking 150 minutes of moderate to vigorous physical activity per week (based on self report). • Full time wheelchair dependent • Unable to wear a Stepwatch • Not a regular user of a mobile phone (look at phone < 1/week) or have no internet access

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026