High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study (HYPE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Attendance of Exercise Sessions
研究概览
简要总结
The purpose of this study is to determine whether a 16-week virtual, home-based, high-intensity interval training (HIIT) exercise program will improve physical, cognitive, and emotional health among young adult survivors of pediatric brain tumors.
The names of the study interventions involved in this study are/is:
- High-Intensity Interval Training (HIIT)
详细描述
This is a Pilot/Feasibility, randomized control, research study that will compare an exercise group to a control group on physical, social, and overall quality of life needs of pediatric brain tumor survivors who are now young adults.
Participants will be randomized (selected at random) for two groups: HIIT program group will complete a 16-week intervention period followed by a 16-week period with no intervention and the waitlisted control group will complete a 16-week period and will perform their usual, daily activities followed by an optional 16-week period in which they can complete the HIIT program.
Research procedures include screening for eligibility, study treatment including in-clinic evaluations of fitness and strength, blood collection, at-home zoom exercise sessions, self-administered activity logs, and survey questionnaires.
Participation in this research study is expected to last about 8 months.
It is expected that about 30 people will take part in this research study.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent prior to any study-related procedures.
- •At time of study are a young adult, aged 18-45 years.
- •Histologically diagnosed brain tumor during childhood, or currently diagnosed with an IDH-mutant glioma (diagnosed > 18 years).
- •Are at least 2 years post tumor-directed therapy for pediatric brain tumor survivors, or at least 1 year since their most recent surgery, radiation or chemotherapy treatment for IDH-mutant glioma patients (or are deemed able to participate in the study based on the assessment of their treating physician). IDH-mutant glioma patients can participate while on maintenance therapy with an IDH inhibitor.
- •The effects of exercise on the developing fetus are unknown. For this reason, people of child-bearing potential must verify pregnancy status by providing first day of their last menstrual cycle and agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry. Should a person become pregnant or suspect that they are pregnant while participating on the trial, they should inform their treating physician immediately.
- •Medically cleared to participate in exercise by their referring physician or a certified clinical exercise physiologist.
- •If participants have a diagnosis of tumor-related epilepsy, they must have good seizure control, with no generalized seizures in the 6 months preceding enrollment.
- •Are without any other medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases.
- •Speak English and/or Spanish.
- •Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week.
- •Does not smoke cigarettes or e-cigarettes (no smoking during the previous 12 months). Those who infrequently smoke in social settings will be included. Those who vape will also be included.
- •Willing to travel to DFCI for necessary data collection.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Diagnosis of primary spinal cord tumor.
- •Pre-existing medical conditions such as uncontrolled tumor-related epilepsy, cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise.
- •Patients with evidence of progressive CNS or systemic cancer in the last 3 months.
- •People who are pregnant, or plan to become pregnant during study duration will be excluded due to the unknown nature of exercise on developing fetuses.
- •Actively on a weight loss diet.
- •Participate in more than 60 minutes of moderate or vigorous structured exercise/week.
- •Currently and regularly smokes.
- •Unable to travel to DFCI for necessary data collection.
- •May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.
研究组 & 干预措施
HIIT Exercise Program Group
Participants will be randomly assigned to the HIIT exercise group and receive:
- 3x weekly for 16 week home-based virtually supervised High-Intensity Interval Training.
- 16-week self-directed exercise follow up period.
- 3 On-site visits at Week 1, 18 and 34 for assement testing and completion of questionnaires
干预措施: HIIT Exercise Program (Behavioral)
Control Group
Participants will be randomly assigned to the HIIT waitlist control group and receive:
- Daily usual activities
- 2 On-site visits at Week 1, and 18 for assement testing and completion of questionnaires
- Option to complete 16 week, 3x weekly HIIT exercise program after initial 16 week period.
干预措施: Control Group (Behavioral)
结局指标
主要结局
Attendance of Exercise Sessions
时间窗: From first exercise session to final exercise session, up to 16 weeks
Defined as participant attendance of \>= 70% of the 48 HIIT exercise sessions.
Barriers to Exercise Adherence
时间窗: From first exercise session to final exercise session, up to 16 weeks
Assessed through the 17-item Barriers to Recruitment Participation Questionnaire (BRPQ), 1-5 scale with 1 denoted as strongly agree and 5 as strongly disagree.
Participant Burden
时间窗: From first exercise session to final exercise session, up to 16 weeks
Assessed through the Perceived Research Burden Assessment (PRBA), 1-5 scale with 1 denoted as strongly disagree and 5 as strongly agree.
Completion in Minutes of Exercise Sessions
时间窗: From first exercise session to final exercise session, up to 16 weeks
Defined as participant completion of \>= 70% of the 90 minutes of exercise per week
HIIT Compliance
时间窗: From first exercise session to final exercise session, up to 16 weeks
Defined as obtaining +-5W of target power output for \>= 40 seconds of high intensity minute
次要结局
- Quality of Sleep(From baseline to post-intervention, up to 43 weeks)
- Fatigue(From baseline to post-intervention, up to 43 weeks)
- Muscular Strength(From baseline to post-intervention, up to 43 weeks)
- Cognition(: From baseline to post-intervention, up to 43 weeks)
- Body Composition(From baseline to post-intervention, up to 43 weeks)
- Psychosocial Health(From baseline to post-intervention, up to 43 weeks)
- Cardiorespiratory Fitness(From baseline to post-intervention, up to 43 weeks)
- Dietary Assessment, ASA-24(Up to 3 days)
- ActiGraph - Physical Activity Monitoring(From baseline to post-intervention, up to 27 weeks)
- Exercise Tolerance(From baseline to week 16, up to 32 weeks)
- Pain Index(From baseline to post-intervention, up to 43 weeks)
- Hip and Waist Circumference(From baseline to post-intervention, up to 43 weeks)
研究者
Christina Dieli-Conwright, PhD
Principal Investigator
Dana-Farber Cancer Institute