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

NCT05763563 | Completed

• 1 other identifier: MCC-22115
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma; Leukemia; Myeloma

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (1)

Exercise prehabilitation

EXPERIMENTAL

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; Behavioral: Aerobic Exercise; Behavioral: Optional Aerobic Exercise Procedure; Radiation: Optional In-Person Exercise Sessions

Interventions

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.

Exercise prehabilitation

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

Exercise prehabilitation

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.

Exercise prehabilitation

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.

Exercise prehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Cancer and Aging Research Group: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trial Search

MeSH Terms

Conditions

Lymphoma; Leukemia; Neoplasms, Plasma Cell

Interventions

Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nathan Parker, PhD, MPH

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Ciara Freeman, MD, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: February 21, 2023
• Primary Completion: January 19, 2025
• Study Completion: January 19, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)