Remotely Monitored, Mobile Health-supported, High Intensity Interval Training Before Hematopoietic Stem Cell Transplant

NCT06953648 | Not Yet Recruiting DMC

• 1 other identifier: REMM-HIIT
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hematopoietic Stem Cell Transplantation; Cardiorespiratory Fitness

Keywords

High Intensity Interval Training; HIIT; Hematopoietic Stem Cell Transplantation; Remote Monitoring; Mobile Health; Exercise; Cardiorespiratory Fitness

Outcome Measures

Primary Outcomes (2)

• Change in Cardiorespiratory Fitness

  Change in cardiorespiratory fitness as measured by the difference in peak rate of oxygen consumption (VO2peak) in mL/(kg\*min) from baseline to the pre-hematopoietic stem cell transplant (HCT) timepoint; a higher number for VO2 peak indicates greater cardiorespiratory fitness.

  At Baseline, Day -10, Day 90, and Day 365

• Change in Physical Function (Six Minute Walk Test Distance)

  The change in physical function as measured by the difference in six minute walk test distance in meters from baseline to the pre-hematopoietic stem cell transplantation (HCT) timepoint; a greater number of meters walked indicates a higher level of physical function.

  At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365

Secondary Outcomes (24)

• Effect on Health-related Quality of Life (Physical Activity/Short Physical Performance Battery)

  At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365

• Effect on Health-related Quality of Life (Physical Activity/30-Second Sit-to-Stand Test)

  At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365

• Effect on Health-related Quality of Life (Physical Activity/Fried Frailty)

  At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365

• Effect on Health-related Quality of Life (Physical Activity/Fall Question)

  At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365

• Effect on Health-related Quality of Life (Physical Activity/Physical Function Questionnaire)

  At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365

Other Outcomes (5)

• Effect on Muscle Health (Resting Energy Expenditure)

  At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365

• Effect on Muscle Health (Intramuscular Adipose Tissue)

  At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365

• Effect on Muscle Health (Glycogen Stores)

  At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365

Study Arms (2)

HIIT Group

EXPERIMENTAL

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).

Behavioral: High Intensity Interval Training

Control Group

NO INTERVENTION

Participants will receive a handout and information on exercise.

Interventions

High Intensity Interval Training BEHAVIORAL

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). As participants' fitness improves, the interval intensity will increase accordingly.

HIIT Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Plan to undergo allogeneic hematopoietic stem cell transplant in 4-12 weeks after enrollment on this study.
• Age 18-80 years
• Able to read/write English (as many participant-reported outcome measures lack validated translations in other languages)

You may not qualify if:

• Unable or unwilling to follow coaching
• Functional impairment resulting in inability to exercise
• Any absolute contraindications to exercise:
• recent (\<6 months) acute cardiac event;
• unstable angina;
• uncontrolled dysrhythmias causing symptoms;
• symptomatic aortic stenosis;
• uncontrolled symptomatic heart failure;
• acute pulmonary embolus;
• acute myocarditis or pericarditis;
• suspected or known dissecting aneurysm

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (3)

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

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MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anthony Sung, MD

  The University of Kansas Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Sung

CONTACT

913-588-6030; asung2@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: May 1, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)