Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For CAR-T Cell Immunotherapy
NCT ID: NCT05763563
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
20 participants
INTERVENTIONAL
2023-02-21
2026-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Exercise prehabilitation
Participants will take part in an exercise program in which they will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week until they undergo CAR-T therapy (Approximately 4-6 weeks). Participants will also be encouraged to perform moderate aerobic exercise such as brisk walking or using stationary aerobic equipment at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise.
Resistance Training
Participants will be encouraged to perform approximately 30 minutes of resistance training exercises twice per week, until they undergo CART-T therapy. Exercises will be performed using resistance tubes (Bodylastics Resistance Bands Set) and a connectable bar (Bionic Body Workout Bar) that mimics a weighted barbell when tubes are attached. The tubes provide up to 142 pounds of resistance (adjustable in increments between 3-10 pounds) when simultaneously connected to handles or bar, and multiple tubes can be attached simultaneously.
Aerobic Exercise
Participants will be encouraged to perform ≥30 minutes of moderate-intensity aerobic exercise on ≥3 days per week. Aerobic exercise intensity will be guided by heart rate zones, with participants exercising at 50-70% of their age-predicted maximum heart rate in bouts of at least 10 minutes at a time. Participants will be encouraged to gradually increase exercise intensity and duration until they are meeting the recommendation
Optional Aerobic Exercise Procedure
Participants will be encouraged to complete 3 tele-supervised aerobic training sessions per week, each lasting 30 minutes. Participants will be encouraged to achieve moderate exercise intensity based on heart rate visualized on PM5 monitors. Participants will report their heart rates every 3-5 minutes during an exercise session and be encouraged to adjust pedaling cadence or flywheel resistance accordingly to achieve moderate intensity.
Exercise trainers will access logged heart rate ranges (64-76% of age-predicted maximum heart rate) to provide individualized and appropriate guidance during sessions.
Participants who are untrained or otherwise uncomfortable maintaining moderate aerobic intensity for 30 minutes will be encouraged to gradually increase the duration and intensity of their sessions until they are meeting these guidelines.
Optional In-Person Exercise Sessions
Participants who prefer to complete RT and/or aerobic exercise sessions in-person will be allowed to do so. These sessions will be conducted in the Moffitt Promotes Resilience in Oncology Via Exercise (MPROVE) Laboratory using the same equipment participants would use for Zoom sessions, with guidance and supervision from certified exercise trainers.
Interventions
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Resistance Training
Participants will be encouraged to perform approximately 30 minutes of resistance training exercises twice per week, until they undergo CART-T therapy. Exercises will be performed using resistance tubes (Bodylastics Resistance Bands Set) and a connectable bar (Bionic Body Workout Bar) that mimics a weighted barbell when tubes are attached. The tubes provide up to 142 pounds of resistance (adjustable in increments between 3-10 pounds) when simultaneously connected to handles or bar, and multiple tubes can be attached simultaneously.
Aerobic Exercise
Participants will be encouraged to perform ≥30 minutes of moderate-intensity aerobic exercise on ≥3 days per week. Aerobic exercise intensity will be guided by heart rate zones, with participants exercising at 50-70% of their age-predicted maximum heart rate in bouts of at least 10 minutes at a time. Participants will be encouraged to gradually increase exercise intensity and duration until they are meeting the recommendation
Optional Aerobic Exercise Procedure
Participants will be encouraged to complete 3 tele-supervised aerobic training sessions per week, each lasting 30 minutes. Participants will be encouraged to achieve moderate exercise intensity based on heart rate visualized on PM5 monitors. Participants will report their heart rates every 3-5 minutes during an exercise session and be encouraged to adjust pedaling cadence or flywheel resistance accordingly to achieve moderate intensity.
Exercise trainers will access logged heart rate ranges (64-76% of age-predicted maximum heart rate) to provide individualized and appropriate guidance during sessions.
Participants who are untrained or otherwise uncomfortable maintaining moderate aerobic intensity for 30 minutes will be encouraged to gradually increase the duration and intensity of their sessions until they are meeting these guidelines.
Optional In-Person Exercise Sessions
Participants who prefer to complete RT and/or aerobic exercise sessions in-person will be allowed to do so. These sessions will be conducted in the Moffitt Promotes Resilience in Oncology Via Exercise (MPROVE) Laboratory using the same equipment participants would use for Zoom sessions, with guidance and supervision from certified exercise trainers.
Eligibility Criteria
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Inclusion Criteria
* Lymphoma, leukemia, or myeloma with commercial FDA-approved CAR-T delivery planned for ≥4 weeks following enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Able to read and speak English fluently
* Capable of providing informed consent
* For optional, tele-supervised aerobic training procedure involving stationary bicycle delivery, participants must live within a 2-hour drive of Moffitt Cancer Center as determined via Google Maps.
Exclusion Criteria
* Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and Patient-Reported Measurement Information System (PROMIS) screening questions
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV).
* Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT using body weight
* Numeric pain rating scale of ≥ 7 out of 10
* Myopathic or rheumatologic disease that impacts physical function
* Cognitive, visual, or auditory limitations that preclude safe engagement in remotely-supervised resistance training sessions or independent aerobic exercise (as determined by patients' treating oncologists and specified in clinic notes outlining disease history).
65 Years
ALL
No
Sponsors
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Cancer and Aging Research Group
UNKNOWN
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Nathan Parker, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Ciara Freeman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Countries
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Related Links
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Moffitt Cancer Center Clinical Trial Search
Other Identifiers
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MCC-22115
Identifier Type: -
Identifier Source: org_study_id
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