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Completed

NCT Number: NCT05763563

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

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.

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Key information

Conditions

Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoproliferative Disorders Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Resistance training

Behavioral

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

Behavioral

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

Behavioral

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

Radiation

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.

Primary outcomes

  1. Percentage of Participants that Enroll and Consent - Enrollment Feasibility

    Time frame: Up to 12 Months

    Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll

  2. Percentage of Participants that Complete Study Assessments - Retention Feasibility

    Time frame: Up to 3 Months

    Retention will be considered feasible if ≥70% of participants complete study measures

  3. Adherence - Feasibility

    Time frame: 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

  4. Participant Evaluation of Feasibility and Acceptability - Acceptability

    Time frame: 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.

  5. Participant Self-Reported Musculoskeletal Injuries - Safety

    Time frame: 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

  6. Objective physical functioning and fitness - Baseline

    Time frame: 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.

  7. Objective physical functioning and fitness - Follow-up

    Time frame: 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.

  8. Participant Skeletal Muscle Index (SMI) - Baseline

    Time frame: Baseline

    Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans

  9. Participant Skeletal Muscle Index (SMI) - Follow-up

    Time frame: After CAR-T Therapy, Up to 6 Months

    Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans

  10. Participants Health-Related Quality of Life - Baseline

    Time frame: Baseline

    Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey

  11. Participants Health-Related Quality of Life - At 3 Months

    Time frame: Up to 3 Months

    Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey

  12. Participants Health-Related Quality of Life - At 6 Months

    Time frame: Up to 6 Months

    Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey

  13. Participant Self Reported Exercise - Baseline

    Time frame: Baseline

    Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise

  14. Participant Self Reported Exercise - At 3 Months

    Time frame: 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

  15. Participant Self Reported Exercise - At 6 Months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Cancer and Aging Research Group

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2023
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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