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NCT Number: NCT04956133

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

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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Completed all treatment for their oncological or hematological diagnosis >3 months
  • Unable to participate in physical activity as assessed by the patients' healthcare team or physical activity specialist
  • Parent and/or patient cannot understand verbal English
  • 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)

Treatment and study plan

Physical activity

Behavioral

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.

Primary outcomes

  1. Reach

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

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

Secondary outcomes

  1. Attendance

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

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

  2. Adherence

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

    Number of assessments completed out of number of scheduled assessments.

  3. Self-Reported Physical Activity Behaviour

    Time frame: Baseline (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.

  4. Directly Assessed Physical Activity Behaviour

    Time frame: Baseline (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.

  5. Functional Mobility

    Time frame: Baseline (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).

  6. 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)

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

  7. 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)

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

  8. Range of Motion

    Time frame: Baseline (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).

  9. 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)

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

  10. 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)

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

  11. Cancer-Specific 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)

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

  12. Health-Related 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)

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

  13. Symptoms

    Time frame: Baseline (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.

  14. Cognitive Functioning

    Time frame: Baseline (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.

  15. Maintenance of 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)

    Number of participants who maintain physical activity following the program.

  16. Physical Activity Fidelity

    Time frame: Through 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.

  17. Time to Implement and Deliver

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

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

  18. Adverse Events

    Time frame: Through 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.

  19. Healthcare Provider and Staff Uptake

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

S. Nicole Culos-Reed, PhD

CONTACT

[email protected]

403-220-7540

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Children's Hospital
  • Canadian Cancer Society (CCS)
  • Canadian Institutes of Health Research (CIHR)
  • Stollery Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jul 9, 2021
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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