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Move to Improve: A single-arm, pragmatic feasibility trial of an individualised physical activity program for children with chronic conditions

Move to Improve: A single-arm, pragmatic feasibility trial of an individualised physical activity program for children with chronic conditions

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000836538
Acronym
M2I
Enrollment
100
Registered
2024-07-05
Start date
2024-07-29
Completion date
2024-11-30
Last updated
2024-07-15

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

Conditions

None listed

Brief summary

This research aims to: (1) assess key implementation and sustainability indices of implementing an individualised physical activity program for children with chronic health conditions, (2) test preliminary effects of the individualised physical activity program on physical activity, health, and psychosocial outcomes, (3) determine the cost of delivering the program. Who is it for? You may be eligible for this study if you are a pediatric patient aged between 5 and 18 years with one of four chronic health conditions: type 1 diabetes, cancer, post-burn injuries, or cerebral palsy Study details The Move to Improve team will work with the child and family to develop an individualised physical activity program aligned with the participants’ goals. Participants will be encouraged to follow the program over the 8-week duration of the intervention. To support participation in the individualised program and address specific barriers to physical activity, the Move to Improve team will provide additional resources (e.g., information sheets) as required. Participants will receive weekly support as required and additional support from psychologist and dietitian if needed. The child's physical activity, quality of life, goal attainment, as well as other mental and physical changes, will be assessed at 6 and 12 months follow-up. It is hoped that findings from this study will support children with chronic health condition to be more physically active.

Interventions

Move to Improve has been co-designed by consumers, researchers and health professionals, and the program will be individually tailored to support children to develop physical activity goals that are fun and sustainable. The multidisciplinary Move to Improve team will help children to build motivation, skills and the confidence required to lead an active lifestyle. The Move to Improve program team will consist of a Senior Exercise Physiologist, Senior Physiotherapist, Senior Clinical Psychologist

Move to Improve has been co-designed by consumers, researchers and health professionals, and the program will be individually tailored to support children to develop physical activity goals that are fun and sustainable. The multidisciplinary Move to Improve team will help children to build motivation, skills and the confidence required to lead an active lifestyle. The Move to Improve program team will consist of a Senior Exercise Physiologist, Senior Physiotherapist, Senior Clinical Psychologist, Senior Dietician, Enrolled Nurse, Allied Health Assistant, Advanced Trainee, and Aboriginal Health Worker. The Move to Improve team will work with the child and family to develop an individualised physical activity program aligned with the participants’ goals as identified using the Canadian Occupational Performance Measure (COPM) tool. During the initial assessment, the Move to Improve program team will work with the family to draft a rough plan for the 8 sessions. The Move to Improve program team will then have approximately 10 days to develop a more structured plan based on this initial conversation. This 8 week plan will be flexible, and likely to change throughout the intervention, in order to reflect how the family is going and the child’s individual circumstances and needs. The program will broadly aim to build towards meeting the physical activity guidelines of 60 minutes per day of moderate-vigorous physical activity and will include a combination of aerobic, strength training, flexibility, and coordination exercises. Participants will be encouraged to follow the program over the 8-week duration of the intervention. To support participation in the individualised program and address specific barriers to physical activity, the Move to Improve team will provide additional resources (e.g., information sheets) as required. Over the course of the 8-week intervention, participants will have access to 1 hour/week one-to-one sessions from the Move to Improve program team to support implementation of the program (e.g., addressing any barriers) and achievement of identified goals. Additional psychology and dietetic support will be provided to participants for whom these are identified barriers to physical activity participation. Based on initial screening from the referral, questionnaires and medical chart review, clinical psychology will provide consultation and liaison to families and their treating teams about mental health support and also about utilising physical activity to improve mood, anxiety and general wellbeing. Based on the initial screening and diet history, the dietician will conduct one-to-one consultations with families of children identified as needing dietetic input during the program. Dietetic support may include (but is not limited to) individual dietary goals and diabetes management support as required. During this period, programs may be adjusted by the Move to Improve team based on the child’s progression towards the predetermined end goal. One-to-one sessions may take place at Perth Children’s Hospital, via Telehealth, in community settings, or home visits depending on clinical judgment of what is required to support the child’s progression towards their physical activity goals. The Move to Improve team will capture adherence in the form of session notes by prompting families on their engagement in the prescribed program and physical activity more broadly since the previous session. Feasibility of intervention delivery will be assessed by the Move to Improve research team using the RE-AIM framework. A parent/primary caregiver of participating children will also be included in the study. Their involvement will be to respond to online parent-report questionnaires and complete physical activity diaries to record their child's physical activity).

Sponsors

Perth Children's Hospital, Child and Adolescent Health Service
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Paediatric patients aged between 5 and 18 years with one of four chronic health conditions: Type 1 Diabetes: diagnosed for >6 months Cancer: treated for any type of cancer, members of the Late Effects and Survivorship Program (5 years from end of treatment), ambulant Post-burn injuries: at least 6 weeks post-burn injury (outpatients) Cerebral palsy: ambulant (Gross Motor Functional Classification level I-III of all motor types) A parent/primary caregiver of children meeting the eligibility criteria above will also be included in the study (their involvement will be to respond to online parent-report questionnaires and complete physical activity diaries to record their child's physical activity).

Exclusion criteria

Participants will be excluded if: They have limited ability to communicate insight into a preferred future (needs, wants and desires) in spoken English and/or through an interpreter or augmentative and alternative communication and/or children with moderate-to-severe intellectual disability as defined by the 10th revision of the International Statistical Classification of Diseases and Related Health Problems as IQ<50 They have uncontrolled epilepsy (as this may impact on safety to engage in certain PA) They have a severe visual impairment or blindness (defined as 6/60 or lower vision) They have severe asthma exacerbated by exercise that is not controlled with medications under an asthma management plan They have a life expectancy of <6 months They are pregnant They are scheduled for any major surgeries throughout the project that are likely to impact ability to participate in Move to Improve, on advice of medical team Aged =18 years

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026