Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For CAR-T Cell Immunotherapy

Study Overview
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Brief Summary
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The purpose of the study is to evaluate an exercise program for individuals preparing for Chimeric Antigen Receptor (CAR) T-cell immunotherapy for hematological malignancies.

Official Title
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Feasibility Of Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For Chimeric Antigen Receptor (CAR) T-Cell Immunotherapy

Conditions
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Lymphoma, Leukemia, Myeloma

Intervention / Treatment
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* Behavioral: Resistance Training
* Behavioral: Aerobic Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥65 years 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 Exclusion Criteria: Regular engagement in Resistance training (2x/week targeting all major muscle groups) 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).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise prehabilitation<br>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. | Behavioral: Resistance Training<br>* 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.<br>Behavioral: Aerobic Exercise<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants that Enroll and Consent - Enrollment Feasibility | Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll | Up to 12 Months | 
| Percentage of Participants that Complete Study Assessments - Retention Feasibility | Retention will be considered feasible if ≥70% of participants complete study measures | Up to 3 Months | 
| Adherence - Feasibility | Adherence will be based on participants attending ≥ 70% of tele-RT sessions on average and performing ≥ 70% of prescribed moderate-intensity aerobic exercise per week | Up to 3 Months | 
| Participant Evaluation of Feasibility and Acceptability - Acceptability | Participants evaluation of feasibility and acceptability will be assessed with a questionnaire, adapted to fit the intervention. The questionnaire includes both Likert Scale and open-ended questions. An item-by-item basis and as average item score, with scores ≥4 (agree to strongly agree) indicating acceptability. Open-ended responses will be analyzed qualitatively to inform intervention improvement. | Up to 3 Months | 
| Participant Self-Reported Musculoskeletal Injuries - Safety | The numerator of the safety variable will be the number of musculoskeletal injuries or adverse health events reported as likely related or definitely related the exercise programming and that caused at least some limitation of daily activity lasting more than 3 days. The denominator of the safety variable will be the number of exercise sessions performed by the participant (tele-resistance training plus aerobic exercise sessions lasting ≥10 minutes). The intervention will be considered safe if the rate of musculoskeletal injuries (i.e., muscle strains or pulls, sprains, exacerbated bone pain, fractures or breaks, or other adverse health events incurred during exercise sessions) is lower than the published metric of 11.9 injuries per 1000 sessions, as used as a benchmark in previous exercise oncology research | Up to 3 Months | 
| Objective physical functioning and fitness - Baseline | Physical functioning and fitness will be assessed using the 30-second chair stand test,30-second arm curl test, and treadmill 6-minute walk test. | At Baseline | 
| Objective physical functioning and fitness - Follow-up | Physical functioning and fitness will be assessed using the 30-second chair stand test,30-second arm curl test, and treadmill 6-minute walk test. | Up to 3 Months | 
| Participant Skeletal Muscle Index (SMI) - Baseline | Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans | Baseline | 
| Participant Skeletal Muscle Index (SMI) - Follow-up | Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans | After CAR-T Therapy, Up to 6 Months | 
| Participants Health-Related Quality of Life - Baseline | Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey | Baseline | 
| Participants Health-Related Quality of Life - At 3 Months | Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey | Up to 3 Months | 
| Participants Health-Related Quality of Life - At 6 Months | Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey | Up to 6 Months | 
| Participant Self Reported Exercise - Baseline | Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise | Baseline | 
| Participant Self Reported Exercise - At 3 Months | Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise | Up to 3 Months | 
| Participant Self Reported Exercise - At 6 Months | Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise | Up to 6 Months |