Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For CAR-T Cell Immunotherapy
- Conditions
- LeukemiaMyelomaLymphoma
- Interventions
- Behavioral: Resistance TrainingBehavioral: Aerobic ExerciseBehavioral: Optional Aerobic Exercise ProcedureRadiation: Optional In-Person Exercise Sessions
- Registration Number
- NCT05763563
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exercise prehabilitation Optional In-Person Exercise Sessions 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. Exercise prehabilitation Resistance Training 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. Exercise prehabilitation Aerobic Exercise 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. Exercise prehabilitation Optional Aerobic Exercise Procedure 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.
- Primary Outcome Measures
Name Time Method Objective physical functioning and fitness - Follow-up Up to 3 Months 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.
Objective physical functioning and fitness - Baseline At 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.
Participant Evaluation of Feasibility and Acceptability - Acceptability Up to 3 Months 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.
Adherence - Feasibility Up to 3 Months 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
Participant Skeletal Muscle Index (SMI) - Baseline Baseline Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Participant Self Reported Exercise - At 3 Months Up to 3 Months Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participant Self Reported Exercise - At 6 Months Up to 6 Months Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participant Self-Reported Musculoskeletal Injuries - Safety Up to 3 Months 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
Participants Health-Related Quality of Life - Baseline Baseline Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Percentage of Participants that Enroll and Consent - Enrollment Feasibility Up to 12 Months Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll
Percentage of Participants that Complete Study Assessments - Retention Feasibility Up to 3 Months Retention will be considered feasible if ≥70% of participants complete study measures
Participant Skeletal Muscle Index (SMI) - Follow-up After CAR-T Therapy, Up to 6 Months Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Participant Self Reported Exercise - Baseline Baseline Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participants Health-Related Quality of Life - At 3 Months Up to 3 Months Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Participants Health-Related Quality of Life - At 6 Months Up to 6 Months Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States