'Rainbow Riders': A Pilot Trial of CyberCycling to Reduce Therapeutic Side Effects and Improve Quality of Life in Adolescent and Young Adults (AYA) Diagnosed With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Proportion of Patient Adherence as recorded by attendance log
研究概览
简要总结
Only a few clinical trials evaluating the potential benefits of exercise have been conducted in adolescents and young adults (AYA) with cancer and, no prior studies have evaluated the potential effects of 'cybercycling' (exergaming on a stationary bike) in AYA cancer survivors. Therefore, the study aims to conduct a pilot trial to determine feasibility (adherence, user acceptance) and to explore potential effects of a 'cybercycling' exercise program on fitness, body composition, quality of life, sleep and cognition.
详细描述
Objectives Specific Aim 1: To evaluate the feasibility (adherence; user acceptance: exercise tolerance, enjoyment and motivation) of performing an adaptive, moderate intensity, aerobic exercise program on a 'cybercycle' compared to control (stretching/resistance bands) in adolescent and young adults (AYA) with cancer.
(Exploratory) Aim 2: To explore the effects of an adaptive, moderate intensity aerobic exercise program using a 'cybercycle' compared to control (stretching/resistance bands) on changes in fitness, body composition, quality of life (QoL), fatigue, sleep and cognition.
Study Design/Overview:
This study is a randomized trial in 20 adolescent and young adult (AYA) cancer survivors (15-30 years old) which will comparing two intervention arms: 1) aerobic exercise on a 'cybercycle' (stationary cycling with exergaming/videogaming); and, 2) a stretching/resistance band 'control' condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed cancer
- •completed primary treatment
- •approved to be contacted by the treating oncologist/nurse practitioner
- •meet screening criteria
排除标准
- •patients unable to provide informed consent
- •patients not available for follow-up testing
- •patients with any pre-existing medical conditions that would be a contraindication to exercise.
结局指标
主要结局
Proportion of Patient Adherence as recorded by attendance log
时间窗: Up to 12 weeks after beginning program
Adherence rates will be summarized separately by treatment arm with proportions and exact confidence intervals. Feasibility will be defined as an adherence of greater than or equal to 80%
次要结局
- Median Tolerance of Exercise Intensity as measured by the Preference for and Tolerance of Exercise Intensity Questionnaire (PRETIE-Q) score(Up to 12 weeks after beginning program)
- Median Physical Activity Enjoyment Scale (PAES) score(Up to 12 weeks after beginning program)
- Median Flow State Scale (FSS) Score(Up to 12 weeks after beginning program)
- Median total duration of each session(Up to 12 weeks after beginning program)
- Median workload of participants while exercising(Up to 12 weeks after beginning program)
- Median Exercise Motivations (EMI) Score(Up to 12 weeks after beginning program)
- Median speed in rpm of participants while exercising(Up to 12 weeks after beginning program)
- Median change of peak pulmonary oxygen uptake (VO2Peak)(Up to 12 weeks after beginning program)
- Median time in total heart rate zone (THZ)(Up to 12 weeks after beginning program)