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

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06953648
Status
Not Yet Recruiting

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Conditions

  • Cardiorespiratory Fitness
  • Hematopoietic Stem Cell Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
May 31, 2025
Status verified
Apr 2025
Primary completion
Oct 31, 2028
Completion
Mar 31, 2030

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: HIIT Group
    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).
  • No Intervention: Control Group
    Participants will receive a handout and information on exercise.

Primary Outcome Measure

Change in Cardiorespiratory Fitness [ Time Frame: At Baseline, Day -10, Day 90, and Day 365 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer CenterKansas CityKansas66160
Anthony Sung, MD
[email protected]
913-588-6030
Anthony Sung, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27705
Amy Pastva, MD
[email protected]
919-681-4380
Amy Pastva, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Ajay Sheshadri, MD
[email protected]
713-563-1987
Ajay Sheshadri, MD (PRINCIPAL_INVESTIGATOR)

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University of Kansas Cancer Center· Kansas City, KSDuke University· Durham, NCThe University of Texas MD Anderson Cancer Center· Houston, TX

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