Design and methods of a randomized telehealth-based intervention to improve fitness in survivors of childhood cancer with exercise intolerance

Exercise intolerance among childhood cancer survivors substantially increases risk for early mortality, reduced cognitive function, poor quality of life, emotional distress, and sub-optimal participation in social roles. Fortunately, exercise intolerance is modifiable, even among individuals with im...

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Veröffentlicht in:Contemporary clinical trials 2023-10, Vol.133, p.107339-107339, Article 107339
Hauptverfasser: Maharaj, Arun, Jefferies, John L., Mulrooney, Daniel A., Armstrong, Gregory T., Brinkman, Tara M., O'Neil, Sean T., Terrell, Sarah, Partin, Robyn E., Srivastava, Deo Kumar, Hudson, Melissa M., Wang, Zhaoming, Ness, Kirsten K.
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Sprache:eng
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Zusammenfassung:Exercise intolerance among childhood cancer survivors substantially increases risk for early mortality, reduced cognitive function, poor quality of life, emotional distress, and sub-optimal participation in social roles. Fortunately, exercise intolerance is modifiable, even among individuals with impaired cardiopulmonary and neuromuscular health. This study aims to evaluate the impact of tailored exercise intervention remotely supervised by fitness professionals in survivors with exercise intolerance. Telehealth-based delivery of the intervention aims to enhance uptake by removing the burden of travel and allowing participants to gain confidence with exercise and physical activity at home. This is an ongoing single-blind, two-arm, prospective, clinical trial that will randomize 160 participants 1:1 to intervention (n = 80) and attention control (n = 80) groups. The intervention group receives an individually tailored exercise prescription based on results from baseline assessments performed remotely via a Health Insurance Portability and Accountability Act-compliant virtual platform and personal preferences for aerobic exercise. Each prescription includes aerobic and strengthening components designed to progress gradually to 150–300-min of moderate aerobic activity and twice weekly strengthening exercises over 20-weeks. The first two weeks are supervised for 6 sessions, tapering to twice/week for weeks 3–4, once/week for weeks 5–8, every other week for weeks 9–16 and once midway between weeks 17–20. The schedule is modifiable depending on participant need, adherence, and response to exercise. Each session is approximately one hour. This study tests the efficacy of an individually prescribed, virtually supervised exercise intervention on exercise intolerant childhood cancer survivors. Clinicaltrials.gov registration: NCT04714840. •Childhood cancer survivors are physically inactive, increasing early mortality risk.•Exercise intolerance, poor quality of life, and emotional distress are also prevalent.•A remotely supervised exercise intervention may improve these outcomes in survivors.•This Telehealth-based protocol aims to improve adherence and confidence with exercise.
ISSN:1551-7144
1559-2030
1559-2030
DOI:10.1016/j.cct.2023.107339