High Intensity Interval Training for Bone Marrow Transplant

(REMM-HIIT Trial)

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

126 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Remotely Monitored, Mobile Health-supported, High Intensity Interval Training for Bone Marrow Transplant?

Research shows that exercise, including high-intensity interval training, can improve physical fitness and reduce fatigue in patients undergoing stem cell transplants. A study found that a home-based aerobic exercise program improved aerobic fitness and physical well-being in cancer survivors who had stem cell transplants, suggesting that structured exercise programs can be beneficial. ^{1 2 3 4 5}

Is high intensity interval training safe for people undergoing bone marrow transplant?

Research on exercise programs, including high intensity interval training, for people undergoing bone marrow transplants shows that these programs are generally safe. In several studies, no exercise-related adverse events were reported, indicating that such exercise interventions can be safely implemented in this population. ^{3 4 6 7 8}

How is the treatment of High Intensity Interval Training for Bone Marrow Transplant different from other treatments?

This treatment is unique because it uses high intensity interval training (short bursts of intense exercise) that is remotely monitored and supported by mobile health technology, making it more accessible and potentially more engaging for patients compared to traditional exercise programs. It leverages wearable technology to help overcome barriers to exercise, which is not commonly used in standard treatments for bone marrow transplant patients. ^{1 2 4 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to learn how a remotely monitored high-intensity interval training (REMM-HIIT) affects the cardiorespiratory fitness and physical function for patients planning to undergo stem cell transplantation. The main questions it aims to answer are: Is there a change in the participant's cardiorespiratory fitness level? Is there a change in the participant's physical function? Researchers will compare the REMM-HIIT program to a control group of participants who do not take part in the training program to see if REMM-HIIT helps improve stem cell transplantation outcomes. Participants will: * Complete cardiopulmonary exercise testing (CPET) 4 times during the study * Do basic tests to measure physical function 6 times during the study * Answer questions about their life and how they are feeling 6 times during the study * Wear a device to keep track of step counts and heart rate daily * Keep a log of every time they exercise throughout the study * Optionally, provide blood and stool samples 6 times during the study

Research Team

Anthony Sung, MD

Principal Investigator

The University of Kansas Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. United States 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. [2013]

2. England pubmed.ncbi.nlm.nih.gov

A randomized control trial of a supervised versus a self-directed exercise program for allogeneic stem cell transplant patients. [2009]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise before, during, and after Hospitalization for Allogeneic Hematological Stem Cell Transplant: A Feasibility Randomized Controlled Trial. [2020]

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

Pilot study of a home-based aerobic exercise program for sedentary cancer survivors treated with hematopoietic stem cell transplantation. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Motivation for physical activity before and after allogeneic hematopoietic stem cell transplantation. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Personalized home-based interval exercise training may improve cardiorespiratory fitness in cancer patients preparing to undergo hematopoietic cell transplantation. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Lessons learned from a pilot randomized clinical trial of home-based exercise prescription before allogeneic hematopoietic cell transplantation. [2021]

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

Physical Activity and Sleep Measures Using a Fitness Tracking Device during Hematopoietic Cell Transplantation: A Pilot Study. [2021]

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

Wearable Monitors Facilitate Exercise in Adult and Pediatric Stem Cell Transplant. [2023]