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IMPACT: IMplementation of Physical Activity for Children and Adolescents on Treatment

Effectiveness and Implementation of Physical Activity for Children and Adolescents on Treatment for Cancer and/or Blood Diseases

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04956133
Enrollment
250
Registered
2021-07-09
Start date
2022-08-03
Completion date
2028-06-01
Last updated
2025-03-07

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

Conditions

Pediatric Cancer, Pediatric Hematology

Keywords

Childhood cancer, Adolescent cancer, In-patient, Out-patient, Oncology, Hematology

Brief summary

Physical activity can enhance well-being among youth diagnosed with oncological or hematological diseases. We developed a tailored, 1:1, online physical activity program (i.e., IMPACT), to promote physical activity in this cohort. The proposed single-group, mixed-methods project will assess the effect of IMPACT and explore markers of implementation.

Interventions

BEHAVIORALPhysical Activity

Participants will receive the IMPACT program, which includes a combination of aerobic, resistance, balance, and flexibility exercises conducted 1:1 and delivered online by a physical activity specialist via Zoom. The IMPACT program follows basic physical activity progression principles (i.e., principles of frequency, intensity, time, type, overload and progression). Tailoring will be used to promote fitness and wellness benefits, while ensuring safety. In addition, prominent behaviour change techniques will be provided by physical activity specialists within each 1:1 session. Discussions and worksheets will be provided, depending on participants needs.

Sponsors

Alberta Children's Hospital
CollaboratorOTHER
Stollery Children's Hospital
CollaboratorOTHER
Canadian Cancer Society (CCS)
CollaboratorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University of Calgary
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Children or adolescents between the ages of 5-18 years at enrollment and at least one parent (defined as a caregiver; biological or otherwise) 2. Diagnosed with any oncological and/or hematological diagnosis 3. Currently receiving or scheduled to receive any treatment for any oncological and/or hematological diagnosis or completed treatment \<3 months

Exclusion criteria

1. Completed all treatment for their oncological or hematological diagnosis \>3 months 2. Unable to participate in physical activity as assessed by the patients' healthcare team or physical activity specialist 3. Parent and/or patient cannot understand verbal English 4. Parent is unwilling to be present (i.e., at home, in the same room depending on participant age and functional ability) during the physical activity sessions (required to ensure safety of the child/adolescent)

Design outcomes

Primary

MeasureTime frameDescription
ReachThrough study completion, an average of 6 years.The number of people who participate, and reasons why or why not.

Secondary

MeasureTime frameDescription
AdherenceThrough study completion, an average of 6 years.Number of assessments completed out of number of scheduled assessments.
Self-Reported Physical Activity BehaviourBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)Modified Leisure Time Exercise Questionnaire (Godin & Shephard, 1985). Time spent in mild, moderate, and vigorous activity will be calculated. Higher numbers indicate greater physical activity.
Directly Assessed Physical Activity BehaviourBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)7-day wear period (minimum) with an activity monitor. Higher numbers indicate greater time spent in physical activity and intensity.
Functional MobilityBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)The timed up and go test (shorter time indicates better functional mobility). Note, this and other physical tests to follow were selected based on use with healthy children, children with chronic conditions, and adults with and without chronic conditions (e.g., Bohannon, 1995; Canadian Society of Exercise Physiology, 2019; Deforche et al., 2003; Haas et al., 2017; Jankowski et al., 2015; Kolber & Hanney, 2012; Lemmink et al., 2003; McNeely et al., 2019; Muir et al., 2010; Podsiadlo & Richardson, 1991; Thorsteinsson et al., 2013).
Lower Extremity EnduranceBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)30-second sit to stand test (more sit/stands indicates greater lower extremity endurance).
BalanceBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)Flamingo balance test (longer time without falling, reaching, shuffling/jumping indicates better balance).
Range of MotionBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)Shoulder range of motion (ROM; greater number indicates greater ROM).
FlexibilityBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)sit and reach flexibility (greater distance indicates higher flexibility).
Aerobic CapacityBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)Aerobic step tests (more steps indicates higher aerobic capacity).
AttendanceThrough study completion, an average of 6 years.Number of sessions attended out of the number of sessions offered by study staff.
Health-Related Quality of LifeBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)PedsQL 4.0 Generic Core Scales (Varni et al., 2009). Score range 0-100; higher scores indicate better quality of life.
SymptomsBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)Symptom Screening in Pediatrics Tool (Hyslop et al., 2018). Score range 0-60; higher score indicates more symptoms experienced and greater severity of symptoms experienced.
Cognitive FunctioningBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)Behavior Rating Inventory of Executive Function 2nd Ed (Gioia et al., 2015). Frequency of behaviors are ranked from Never to Often, and results are reported as t scores where higher scores indicate greater deficits.
Maintenance of Physical ActivityBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)Number of participants who maintain physical activity following the program.
Physical Activity FidelityThrough study completion, an average of 6 years.Fidelity of the physical activity program implementation will be assessed via randomly video-auditing a subset of sessions.
Time to Implement and DeliverThrough study completion, an average of 6 years.Time and expertise to deliver the intervention and physical assessments will be tracked.
Adverse EventsThrough study completion, an average of 6 years.Adverse events will be defined as any negative effect caused (or suspected to be caused by) the physical activity program.
Healthcare Provider and Staff UptakeThrough study completion, an average of 6 years.Healthcare providers' and clinical staffs' referral to the physical activity program
Cancer-Specific Quality of LifeBaseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)PedsQL 3.0 Cancer Module (Varni et al., 2009). Score range 0-100; higher scores indicate better quality of life.

Countries

Canada

Contacts

Primary ContactS. Nicole Culos-Reed, PhD
nculosre@ucalgary.ca403-220-7540

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026