High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study

Официальное название

High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study (HYPE)

Обзор

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)

Подробное описание

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.

The Stahl Family Charitable Foundation, Pedal 4 Pediatrics, and the Childhood Brain Tumor Foundation are supporting this research study by providing funding for the study.

Вмешательства

• Поведенческое HIIT Exercise Program
  Exercise program with stationary bike via the Zoom platform.
• Поведенческое Control Group
  Usual Activities

Первичные конечные точки

• Attendance of Exercise Sessions [Срок оценки: From first exercise session to final exercise session, up to 16 weeks]
• Completion in Minutes of Exercise Sessions [Срок оценки: From first exercise session to final exercise session, up to 16 weeks]
• HIIT Compliance [Срок оценки: From first exercise session to final exercise session, up to 16 weeks]
• Barriers to Exercise Adherence [Срок оценки: From first exercise session to final exercise session, up to 16 weeks]
• Participant Burden [Срок оценки: From first exercise session to final exercise session, up to 16 weeks]

Вторичные конечные точки (12)

• Cognition [Срок оценки: : From baseline to post-intervention, up to 43 weeks]
• Cardiorespiratory Fitness [Срок оценки: From baseline to post-intervention, up to 43 weeks]
• Muscular Strength [Срок оценки: From baseline to post-intervention, up to 43 weeks]
• Body Composition [Срок оценки: From baseline to post-intervention, up to 43 weeks]
• Fatigue [Срок оценки: From baseline to post-intervention, up to 43 weeks]
• Psychosocial Health [Срок оценки: From baseline to post-intervention, up to 43 weeks]
• Quality of Sleep [Срок оценки: From baseline to post-intervention, up to 43 weeks]
• Dietary Assessment, ASA-24 [Срок оценки: Up to 3 days]
• ActiGraph - Physical Activity Monitoring [Срок оценки: From baseline to post-intervention, up to 27 weeks]
• Exercise Tolerance [Срок оценки: From baseline to week 16, up to 32 weeks]
• Pain Index [Срок оценки: From baseline to post-intervention, up to 43 weeks]
• Hip and Waist Circumference [Срок оценки: From baseline to post-intervention, up to 43 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Dana Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT05740839 · 22-505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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