High Intensity Interval Training for Bone Marrow Transplant

(REMM-HIIT Trial)

Not yet recruiting at 2 trial locations

Overseen By Anthony Sung

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Recent cardiac event, Unstable angina, Uncontrolled dysrhythmias, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether high-intensity interval training, performed at home and monitored remotely, can improve fitness and physical function for individuals preparing for stem cell transplants. The researchers aim to determine if this exercise program benefits participants compared to those who do not exercise. Suitable candidates for this trial are adults planning a stem cell transplant in the next 4-12 weeks who can read and write English. Participants will track their exercise, heart rate, and steps, and may provide blood and stool samples. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance pre-transplant care.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this high-intensity interval training is safe for patients undergoing stem cell transplantation?

Research shows that high-intensity interval training (HIIT) is generally safe for most people, including those undergoing stem cell transplants. A small initial study tested a similar remotely monitored HIIT program and found that participants handled it well, with no serious safety issues reported. Participants managed the exercise routine, which included both high- and low-intensity activities, suggesting that the HIIT program in this trial could be safe.

Additionally, exercise programs supported by telemedicine, like this one, have shown good results in similar patient groups without major safety problems. This is encouraging for those considering joining the trial, as it suggests the training is likely safe and manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the High Intensity Interval Training (HIIT) protocol for bone marrow transplant patients because it offers a fresh approach to rehabilitation. Unlike traditional exercise regimens that may be less intensive or structured, this HIIT program is remotely monitored and supported by mobile health technology, allowing for personalized feedback and adjustments. The combination of high-intensity bursts and rest periods is designed to maximize cardiovascular benefits in a shorter time, potentially improving patient outcomes and recovery speed. This approach is innovative in its use of technology and intensity to support recovery after a bone marrow transplant.

What evidence suggests that this high-intensity interval training is effective for improving cardiorespiratory fitness and physical function in stem cell transplant patients?

Research shows that high-intensity interval training (HIIT) can enhance heart and lung health, as well as physical abilities, in people recovering from cancer. Studies have found that HIIT helps cancer survivors become healthier and stronger, making it a suitable option for those undergoing stem cell transplants. These improvements are crucial because they can lead to better recovery and a higher quality of life. In this trial, participants in the HIIT Group will engage in remotely monitored, mobile health-supported HIIT sessions. Early results from similar programs suggest that remote monitoring of HIIT can be effective and manageable for patients. This approach may lead to real benefits in participants' fitness and daily activities. ^{1 2 3 6 7}

Who Is on the Research Team?

Anthony Sung, MD

Principal Investigator

The University of Kansas Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients preparing for stem cell transplantation who want to participate in a study evaluating the effects of high-intensity interval training on their fitness and physical function. Participants must be able to complete exercise testing, wear a monitoring device, and keep an exercise log.

Inclusion Criteria

Able to read/write English (as many participant-reported outcome measures lack validated translations in other languages)

I am scheduled for a stem cell transplant from a donor within 4-12 weeks after joining this study.

Exclusion Criteria

I don't have any recent severe heart or lung conditions.

I cannot exercise due to my health condition.

I cannot or will not follow coaching.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-HCT High Intensity Interval Training (HIIT)

Participants engage in a remotely monitored high-intensity interval training program to improve cardiorespiratory fitness before hematopoietic stem cell transplantation.

Approximately 12-16 weeks

Remote monitoring with initial and as-needed videoconference sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cardiorespiratory fitness and quality of life.

12 months

Multiple assessments at Day -10, Day 30, Day 90, Day 180, and Day 365

What Are the Treatments Tested in This Trial?

Interventions

• Remotely Monitored, Mobile Health-supported, High Intensity Interval Training

Trial Overview The study tests if remotely monitored high-intensity interval training (REMM-HIIT) can improve cardiorespiratory fitness and physical function before stem cell transplant. It compares REMM-HIIT participants with a control group not doing the program.

How Is the Trial Designed?

Group I: HIIT Group Experimental Treatment 1 Intervention

The intervention will consist of three 30-minute training sessions/week, each starting with a five-minute warm-up, followed by 20 minutes of interval training, and ending with a five-minute cool-down. The interval training will consist of 10 alternating high- and low-intensity intervals, with a 1:1 work-to-rest ratio (one minute of high intensity followed by one minute of low-moderate intensity).

Group II: Control Group Active Control 1 Intervention

Participants will receive a handout and information on exercise.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

A pilot study involving 17 adult hematopoietic stem cell transplant (HSCT) recipients showed that a home-based aerobic exercise program was safe and led to significant improvements in aerobic fitness, fatigue severity, and physical well-being over 12 weeks.

No exercise-related adverse events were reported, indicating that this individualized exercise approach is an acceptable and potentially effective intervention for enhancing physical functioning in sedentary HSCT recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a home-based aerobic exercise program for sedentary cancer survivors treated with hematopoietic stem cell transplantation. Wilson, RW., Jacobsen, PB., Fields, KK.[2022]

A study involving 83 patients undergoing hematopoietic cell transplantation (HCT) found that physical activity significantly declines during hospital admission, with allogeneic HCT patients being less active than those undergoing autologous HCT.

Despite the decline in physical activity, the study revealed that this decrease did not correlate with HCT-related outcomes such as readmission or survival, indicating that while activity levels drop, they may not impact recovery as previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Sleep Measures Using a Fitness Tracking Device during Hematopoietic Cell Transplantation: A Pilot Study. Jurdi, NE., Nock, N., Fu, P., et al.[2021]

Hematopoietic stem cell transplant (HSCT) can be a curative treatment for blood cancers, but it often leads to decreased quality of life and performance status in patients.

The use of wearable technologies may help overcome barriers to exercise, making it easier for HSCT patients to participate in exercise therapy, which has been shown to improve their outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Monitors Facilitate Exercise in Adult and Pediatric Stem Cell Transplant. Pottebaum, E., Warmoth, A., Ayyappan, S., et al.[2023]

In a study of 61 allogeneic stem cell transplant patients, both therapist-supervised and patient-directed exercise programs led to significant improvements in physical performance, with the supervised group showing slightly better results in walking distances after 4 weeks of training.

Both groups experienced a reduction in fatigue levels, although this change was not statistically significant, indicating that exercise can be beneficial for functional outcomes in transplant patients regardless of supervision style.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized control trial of a supervised versus a self-directed exercise program for allogeneic stem cell transplant patients. Shelton, ML., Lee, JQ., Morris, GS., et al.[2009]

A feasibility randomized controlled trial involving patients undergoing allogeneic hematological stem cell transplant (allo-HSCT) showed that an exercise program delivered before, during, and after the transplant was safe, with no adverse events linked to the exercise intervention.

Participants in the exercise group improved their six-minute walk test distances by an average of 45 meters before the transplant, suggesting that exercise may enhance physical function in this patient population and warrants further research with larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise before, during, and after Hospitalization for Allogeneic Hematological Stem Cell Transplant: A Feasibility Randomized Controlled Trial. Santa Mina, D., Dolan, LB., Lipton, JH., et al.[2020]

Eighteen adolescent and young adult patients undergoing hematopoietic stem cell transplant engaged in exercise during hospitalization, averaging 76% of days and 36.5 minutes per day, primarily using standard activities like walking and resistance training.

Despite high participation rates in exercise, there were no improvements in functional capacity or quality of life, indicating that supervision and structured programs may be necessary to enhance the benefits of exercise for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of voluntary exercise behavior and active video gaming among adolescent and young adult patients during hematopoietic stem cell transplantation. Rosipal, NC., Mingle, L., Smith, J., et al.[2013]

A pilot study tested a 5- to 12-week home-based aerobic exercise program for patients preparing for allogeneic hematopoietic cell transplantation (alloHCT), but it did not show significant improvements in physical function measures like peak oxygen consumption (VO2peak) or 6-minute walk distance (6MWD).

The small number of participants (34 randomized, with only 16 and 12 evaluable for VO2peak and 6MWD, respectively) limited the ability to draw strong conclusions about the efficacy of the exercise intervention, indicating that future studies need better design and participant recruitment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from a pilot randomized clinical trial of home-based exercise prescription before allogeneic hematopoietic cell transplantation. Wood, WA., Weaver, M., Smith-Ryan, AE., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06953648

Remotely Monitored, Mobile Health-supported, High ... The investigators hypothesize that patients undergoing REMM-HIIT program will experience improved CRF, physical function, and QOL pre-HCT, leading to better ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10688680/

A pilot study to assess the feasibility of a remotely ... A pilot study to assess the feasibility of a remotely monitored high-intensity interval training program prior to allogeneic hematopoietic stem cell ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/603816

Remotely Monitored, Mobile Health-supported, High ... The goal of this clinical trial is to learn how a remotely monitored high-intensity interval training (REMM-HIIT) affects the ...

4. withpower.com withpower.com/trial/high-intensity-interval-training-for-bone-marrow-transplant-02129

High Intensity Interval Training for Bone Marrow Transplant ... The goal of this clinical trial is to learn how a remotely monitored high-intensity interval training (REMM-HIIT) affects the cardiorespiratory fitness and ...

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

Clinical updates on the effects of high intensity interval ... To provide an updated critical evaluation on the effectiveness of high intensity interval training (HIIT) on health outcomes amongst cancer survivors.

6. dovepress.com dovepress.com/telemedicine-supported-exercise-interventions-in-hematopoietic-stem-ce-peer-reviewed-fulltext-article-IJGM

Telemedicine-supported Exercise Interventions in ... The outcome improvements resulting from telemedicine-supported exercise programs in HSCT patients are analogous to the outcome improvements ...

7. astctjournal.org astctjournal.org/issue/S2666-6367(20)X0012-1?pageStart=10

March 2021 A Phase 1 Study of the Safety and Feasibility of Improving Cardiorespiratory Fitness through a Remotely Monitored, Mobile Health Supported High Intensity ...