HIIT Exercise for Brain Cancer Survivors

(HYPE Trial)

Overseen By Christina M Dieli-Conwright, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Spinal cord tumor, Cardiopulmonary, Metabolic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 16-week high-intensity interval training (HIIT) program can enhance physical, cognitive, and emotional health in young adults who survived brain cancer as children. Participants will either join a supervised HIIT exercise group or continue their usual activities, with the option to try HIIT later. Suitable candidates for this trial are young adults aged 18-39 who had a brain tumor diagnosed during childhood, are at least two years past treatment, and currently exercise less than 60 minutes a week. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve the quality of life for childhood brain cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this HIIT exercise program is safe for brain cancer survivors?

Research shows that high-intensity interval training (HIIT) is generally safe for cancer patients and survivors. Studies on HIIT report few or no negative effects, indicating that most people can perform the exercise without serious issues. A detailed review of 35 studies with nearly 1,900 participants found that HIIT improved physical health without major safety concerns. Therefore, for cancer survivors, including those recovering from brain tumors, HIIT appears to be a safe and effective way to enhance health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HIIT exercise program for brain cancer survivors because it offers a new approach to improving quality of life post-treatment. Unlike traditional rehabilitation options that might be less intense or structured, HIIT involves short bursts of high-intensity exercise followed by rest, all of which can be done at home with virtual supervision. This method is not only convenient but may also enhance physical fitness and cognitive function more effectively than standard low-intensity exercise routines. The potential to improve mental and physical health through exercise is a promising and empowering option for survivors.

What evidence suggests that HIIT is effective for brain cancer survivors?

Research has shown that high-intensity interval training (HIIT) benefits cancer survivors, including those with a history of brain tumors. In this trial, participants in the HIIT Exercise Program Group will follow a structured HIIT regimen. Studies have found that HIIT enhances cardiovascular and pulmonary function. This exercise type also correlates with improved overall quality of life, boosting physical, social, and mental abilities. Importantly, HIIT is generally safe for cancer survivors, with no serious side effects reported in studies. While results during active cancer treatment can vary, the benefits for survivors remain promising. ^{1 2 3 6 7}

Who Is on the Research Team?

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-39 who survived pediatric brain tumors, are at least two years post-treatment, and currently do little structured exercise. They must be medically cleared for exercise, not smoke or vape, agree to use contraception if applicable, and be willing to travel for data collection. Those with uncontrolled diseases or active malignancies cannot join.

Inclusion Criteria

Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week

My doctor or a certified exercise expert has approved me for exercise.

Written informed consent prior to any study-related procedures

Exclusion Criteria

Patients who are pregnant

Actively on a weight loss diet

Participate in more than 60 minutes of moderate or vigorous structured exercise/week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants in the HIIT group undergo a 16-week home-based, virtually supervised High-Intensity Interval Training program

16 weeks

3 visits (in-person) at Week 1, 18, and 34

Follow-up

Participants are monitored for safety and effectiveness after the treatment period, including a self-directed exercise follow-up period

16 weeks

2 visits (in-person) at Week 18 and 34

Optional Extension

Control group participants have the option to complete a 16-week HIIT exercise program after the initial period

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-Intensity Interval Training (HIIT)

Trial Overview The study tests a virtual 16-week high-intensity interval training (HIIT) program against a control group to see if it improves physical, cognitive, and emotional health in survivors of pediatric brain tumors.

How Is the Trial Designed?

Group I: HIIT Exercise Program Group Experimental Treatment 1 Intervention

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

Group II: Control Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Pedals For Pediatrics

Collaborator

Trials

1

Recruited

30+

Stahl Family Charitable Foundation

Collaborator

Trials

1

Recruited

30+

The Childhood Brain Tumor Foundation

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

High-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) both improved aerobic capacity (VO2peak) and waist circumference in breast cancer survivors over a 12-week program, but there were no significant differences between the two training methods.

While HIIT led to increases in minute ventilation and peak workload, it did not result in a greater improvement in VO2peak compared to MICT, suggesting that both training intensities are beneficial for previously trained breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional cardiovascular fitness when progressing from moderate- to high-intensity exercise training in previously trained breast cancer survivors. Bell, RA., Baldi, JC., Jones, LM.[2021]

High-intensity interval training (HIIT) has been shown to significantly improve cardiorespiratory fitness in breast cancer survivors, based on a review of 13 randomized controlled trials.

All HIIT interventions were supervised and lab-based, indicating a need for further research into the feasibility and effectiveness of home-based or unsupervised HIIT programs for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training in breast cancer survivors: a systematic review. Tsuji, K., Matsuoka, YJ., Ochi, E.[2021]

High-intensity resistance training (HIRT) can be safely implemented in cancer survivors, with no significant difference in safety or feasibility compared to moderate-intensity resistance training (MIRT), based on a study involving 23 participants who completed a 12-week training program.

Both HIRT and MIRT sessions were well-received, with high enjoyment levels reported, although training-related pain should be monitored, as 14 minor adverse events occurred during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of High-Intensity Resistance Training Sessions in Cancer Survivors. Schlüter, K., Schneider, J., Rosenberger, F., et al.[2023]

A submaximal exercise program for glioma patients, consisting of individualized sessions of bicycle ergometry and resistance training, was found to be safe and feasible, with only two minor epileptic events reported during 1828 training sessions.

Patients participating in the program achieved significant cardiorespiratory fitness, with a median survival of 24.1 months for glioblastoma patients, suggesting that exercise may positively impact their overall health and longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conceptual development of an intensive exercise program for glioma patients (ActiNO): summary of clinical experience. Jost, J., Müther, M., Brandt, R., et al.[2023]

High-intensity interval training (HIIT) is safe and feasible for 40 cancer survivors (20 breast and 20 prostate) shortly after completing primary therapy, with 95% of participants successfully completing the protocols and only minor adverse events reported.

Among the two HIIT protocols tested, the 4 × 4 minute protocol resulted in higher energy expenditure and greater physiological strain compared to the 10 × 1 minute protocol, making it potentially more effective for those seeking a higher training stimulus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Two High-Intensity Interval Training Protocols in Cancer Survivors. Schlüter, K., Schneider, J., Sprave, T., et al.[2020]

High-intensity interval training (HIIT) significantly improves cardiorespiratory fitness (CRF) in cancer patients when added to standard cancer treatments, with a small clinical effect size (SMD = 0.45).

HIIT is safe for cancer patients, showing high adherence rates (54% to 100%) and minimal adverse effects, making it a beneficial addition to cancer care for enhancing quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of HIIT in patients with cancer or cancer survivors: An umbrella and mapping review with meta-meta-analysis. Herranz-Gómez, A., Cuenca-Martínez, F., Suso-Martí, L., et al.[2023]

High-intensity interval training (HIIT) is safe and feasible for a small group of pediatric cancer patients aged 6 to 18, with 11 out of 212 eligible patients successfully completing the exercise without serious adverse events.

During HIIT, patients achieved high heart rates (up to 90% of their maximum) and significant increases in blood lactate levels, indicating that while HIIT can be performed, individualized exercise protocols are necessary to accommodate the varying health conditions of childhood cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Bout of High-Intensity Interval Training (HIIT) in Children and Adolescents during Acute Cancer Treatment-A Pilot Feasibility Study. Kesting, S., Weeber, P., Schönfelder, M., et al.[2023]

A 12-week structured exercise program was well tolerated by two female brain cancer patients, with no adverse effects reported, indicating that exercise can be safely integrated into their treatment plans.

Both participants showed significant improvements in physical strength, cardiovascular fitness, and psychological well-being, including reduced anxiety and depression, suggesting that exercise may enhance quality of life for brain cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Improves Physical Function and Mental Health of Brain Cancer Survivors: Two Exploratory Case Studies. Levin, GT., Greenwood, KM., Singh, F., et al.[2018]

Acute high-intensity interval exercise (HIIE) significantly reduced colon cancer cell numbers immediately after exercise in a study involving 20 colorectal cancer survivors, suggesting that exercise may have a direct anti-cancer effect through transient changes in serum composition.

Following HIIE, there were notable increases in inflammatory cytokines like interleukin-6 and tumor necrosis factor-α, indicating that these cytokines may play a role in mediating the exercise's beneficial effects on colorectal cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute high intensity interval exercise reduces colon cancer cell growth. Devin, JL., Hill, MM., Mourtzakis, M., et al.[2020]

High-intensity interval training (HIIT) was found to be feasible and well-tolerated by fatigued adults aged 20-40 with acquired brain injury, with 60% of participants completing the 18-session program.

Participants showed significant improvements in their VO2max and reported increased motivation to exercise, indicating that HIIT may effectively help manage fatigue in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing fatigue following acquired brain injury: A feasibility study of high intensity interval training for young adults. Dornonville de la Cour, FL., Bærentzen, MB., Forchhammer, B., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9804206/

Effectiveness of HIIT in patients with cancer or ... HIIT training seemed to be effective to improve cardiorespiratory fitness in cancer survivors. However, during active treatment, there were contrasting results.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1440244023004218

Clinical updates on the effects of high intensity interval ... High retention rates were recorded at 95 % (79 % to 100 %) for the HIIT groups and 92 % (48 % to 100 %) for control groups, amongst different types of cancer ...

3. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2025.1594574/full

Effects of high-intensity interval training (HIIT) versus ... The results of this study showed that, compared to MICT, HIIT led to a statistically significant increase in VO2 peak in cancer survivors.

4. withpower.com withpower.com/trial/phase-brain-neoplasms-4-2023-2fd08

HIIT Exercise for Brain Cancer Survivors (HYPE Trial) Research suggests that high-intensity interval training (HIIT) is generally safe for cancer survivors, with studies showing no serious adverse events in both ...

5. nature.com nature.com/articles/s41598-021-94476-y

Effects of high-intensity training on the quality of life ... Results showed HIT improved global quality of life, physical functioning, role functioning, social functioning, cognitive functioning, fatigue, pain, dyspnea, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05740839

NCT05740839 | High-Intensity Interval Exercise in Young ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10584719/

Effects of high-intensity interval training on functional ... In terms of relV̇O2PEAK, the performance of cancer patients was improved by HIIT (10.68±6.48%) and MICT (7.4±4.29%). HIIT can be favored to ...