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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Kansas Medical Center

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Unable or unwilling to follow coaching

Functional impairment resulting in inability to exercise

recent (<6 months) acute cardiac event;

unstable angina;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: HIIT GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At Baseline, Day -10, Day 90, and Day 365
2

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.

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

Secondary outcomes

1

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

Effect on health-related quality of life (physical activity) as measured by performance on the Short Physical Performance Battery, which results in a score from 0 to 12 points, with a higher number indicating better physical performance.

Time frame
At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365
2

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

Effect on health-related qulaity of life (physical activity) as measured by the 30-second sit-to-stand test, which measures the number of times an individual can stand up from a chair and sit back down within 30 seconds, with a higher number indicating greater fitness.

Time frame
At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365
3

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

Effect on health-related quality of life (physical activity) as measured by the Fried Frailty assessment, which results in a score from 0 to 5, with a higher number indicating greater frailty.

Time frame
At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365
4

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

Effect on health-related quality of life (physical activity) as measured by the Fall Question, a structured questionnaire asking about any history of falls, with a higher number of falls indicating greater fall risk and physical vulnerability.

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

Other outcomes

1

Effect on Muscle Health (Resting Energy Expenditure)

The effect on muscle health as measured by resting energy expenditure.

Time frame
At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365
2

Effect on Muscle Health (Intramuscular Adipose Tissue)

The effect on muscle health as measured by amount of intramuscular adipose tissue assessed using biopsied muscle tissue.

Time frame
At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365
3

Effect on Muscle Health (Glycogen Stores)

The effect on muscle health as measured by amount of glycogen stores in muscle assessed using biopsied muscle tissue.

Time frame
At Baseline, Day -10, Day 30, Day 90, Day 180, and Day 365
4

Effect on Muscle Health (Muscle Mitochondrial Metabolism)

The effect on muscle health as measured by muscle mitochondrial metabolism assessed in biopsied muscle tissue.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: