Clinical trial · Interventional
Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For CAR-T Cell Immunotherapy
Feasibility Of Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For Chimeric Antigen Receptor (CAR) T-Cell Immunotherapy
NCT05763563CI-TRIAL-00106854completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aerobic Exercise | Behavioral | — | UNRESOLVED |
| Optional Aerobic Exercise Procedure | Behavioral | — | UNRESOLVED |
| Optional In-Person Exercise Sessions | Radiation | — | UNRESOLVED |
| Resistance Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exercise prehabilitation
- description
- 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.
- interventionNames
- Behavioral: Resistance Training
- Behavioral: Aerobic Exercise
- Behavioral: Optional Aerobic Exercise Procedure
- Radiation: Optional In-Person Exercise Sessions
Primary outcomes (15)
- measure
- Percentage of Participants that Enroll and Consent - Enrollment Feasibility
- timeFrame
- Up to 12 Months
- description
- Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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 * 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: * 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).
References
Publications (0)
Data not yet available
No reference posted for this study.