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

Trial Summary

What is the purpose of this trial?

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)

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 data supports the effectiveness of the treatment High-Intensity Interval Training (HIIT) for brain cancer survivors?

Research shows that exercise, including HIIT, can improve physical function and mental health in cancer survivors. In breast cancer survivors, HIIT has been linked to significant improvements in aerobic capacity, which is crucial for overall health. Additionally, exercise has been shown to be safe and beneficial for brain cancer survivors, improving strength, cardiovascular fitness, and psychological well-being. ^{1 2 3 4 5}

Is high-intensity interval training (HIIT) safe for cancer survivors?

Research suggests that high-intensity interval training (HIIT) is generally safe for cancer survivors, with studies showing no serious adverse events in both adult and pediatric cancer patients. However, minor adverse events and increased physical exhaustion have been reported, indicating the need for individually adapted exercise protocols. ^{1 5 6 7 8}

How is HIIT exercise different from other treatments for brain cancer survivors?

HIIT exercise is unique because it focuses on short bursts of high-intensity activity followed by rest, which can improve cardiovascular fitness and mental health without the need for medication. Unlike traditional treatments, it offers a non-drug approach to enhance quality of life and reduce treatment-related health declines in brain cancer survivors. ^{1 2 3 9 10}

Research Team

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

I have heart, lung, or metabolic conditions that worsen with exercise.

Patients who are pregnant

Actively on a weight loss diet

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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 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]

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) 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 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) 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Additional cardiovascular fitness when progressing from moderate- to high-intensity exercise training in previously trained breast cancer survivors. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Exercise Improves Physical Function and Mental Health of Brain Cancer Survivors: Two Exploratory Case Studies. [2018]

3. England pubmed.ncbi.nlm.nih.gov

High-intensity interval training in breast cancer survivors: a systematic review. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Acute high intensity interval exercise reduces colon cancer cell growth. [2020]

5. Denmark pubmed.ncbi.nlm.nih.gov

Effectiveness of HIIT in patients with cancer or cancer survivors: An umbrella and mapping review with meta-meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility of High-Intensity Resistance Training Sessions in Cancer Survivors. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Two High-Intensity Interval Training Protocols in Cancer Survivors. [2020]

8. Switzerland 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Conceptual development of an intensive exercise program for glioma patients (ActiNO): summary of clinical experience. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Reducing fatigue following acquired brain injury: A feasibility study of high intensity interval training for young adults. [2022]