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

University of Calgary250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

250

Conditions

Pediatric Cancer Pediatric Hematology

Interventions

Physical ActivityBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Alberta Children's Hospital

Calgary, Alberta, Canada

RECRUITING

Stollery Children's Hospital

Edmonton, Alberta, Canada

RECRUITING

Outcomes

Primary Outcomes

Reach

The number of people who participate, and reasons why or why not.

Time frame: Through study completion, an average of 6 years.

Secondary Outcomes

Attendance

Number of sessions attended out of the number of sessions offered by study staff.

Time frame: Through study completion, an average of 6 years.

Adherence

Number of assessments completed out of number of scheduled assessments.

Time frame: Through study completion, an average of 6 years.

Self-Reported Physical Activity Behaviour

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.

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Directly Assessed Physical Activity Behaviour

7-day wear period (minimum) with an activity monitor. Higher numbers indicate greater time spent in physical activity and intensity.

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Functional Mobility

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).

Central Contacts

S. Nicole Culos-Reed, PhD

CONTACT

403-220-7540 nculosre@ucalgary.ca

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Lower Extremity Endurance

30-second sit to stand test (more sit/stands indicates greater lower extremity endurance).

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Balance

Flamingo balance test (longer time without falling, reaching, shuffling/jumping indicates better balance).

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Range of Motion

Shoulder range of motion (ROM; greater number indicates greater ROM).

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Flexibility

sit and reach flexibility (greater distance indicates higher flexibility).

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Aerobic Capacity

Aerobic step tests (more steps indicates higher aerobic capacity).

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Cancer-Specific Quality of Life

PedsQL 3.0 Cancer Module (Varni et al., 2009). Score range 0-100; higher scores indicate better quality of life.

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Health-Related Quality of Life

PedsQL 4.0 Generic Core Scales (Varni et al., 2009). Score range 0-100; higher scores indicate better quality of life.

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Symptoms

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.

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Cognitive Functioning

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.

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Maintenance of Physical Activity

Number of participants who maintain physical activity following the program.

Time frame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

Physical Activity Fidelity

Fidelity of the physical activity program implementation will be assessed via randomly video-auditing a subset of sessions.

Time frame: Through study completion, an average of 6 years.

Time to Implement and Deliver

Time and expertise to deliver the intervention and physical assessments will be tracked.

Time frame: Through study completion, an average of 6 years.

Adverse Events

Adverse events will be defined as any negative effect caused (or suspected to be caused by) the physical activity program.

Time frame: Through study completion, an average of 6 years.

Healthcare Provider and Staff Uptake

Healthcare providers' and clinical staffs' referral to the physical activity program

Time frame: Through study completion, an average of 6 years.