LymphomaNCT05763563
Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For CAR-T Cell Immunotherapy
A study testing Resistance Training, Aerobic Exercise and Optional Aerobic Exercise Procedure in people with Lymphoma and Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Resistance Training, Aerobic Exercise and Optional Aerobic Exercise Procedure
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 19 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Of Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For Chimeric Antigen Receptor (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.
- Being tested
- Resistance Training, Aerobic Exercise, Optional Aerobic Exercise Procedure, Optional In-Person Exercise Sessions
- Medical subject headings
- Lymphoma, Leukemia, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
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 ExerciseBehavioural
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 ProcedureBehavioural
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 SessionsRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Resistance Training; Behavioral: Aerobic Exercise; Behavioral: Optional Aerobic Exercise Procedure; Radiation: Optional In-Person Exercise Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline
Participant Skeletal Muscle Index (SMI) - Follow-up
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start21 Feb 2023
- Primary completion19 Jan 2025
- Study completion19 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer and Aging Research Group
- Responsible party
- Sponsor
- Investigators
- Nathan Parker, PhD, MPH, Principal investigator, Moffitt Cancer CenterCiara Freeman, MD, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763563
- Sponsor's protocol ID
- MCC-22115
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Of Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For Chimeric Antigen Receptor (CAR) T-Cell Immunotherapy
- ClinicalTrials.gov ID
- NCT05763563
- Acronym / sponsor ID
- MCC-22115
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Cancer and Aging Research Group
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 19 Jan 2025 (actual)
- Study completion
- 19 Jan 2025 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise prehabilitation | Experimental | Behavioral: Resistance Training, Behavioral: Aerobic Exercise, Behavioral: Optional Aerobic Exercise Procedure, Radiation: Optional In-Person Exercise SessionsParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance TrainingParticipants 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. | Behavioural | Exercise prehabilitation |
| Aerobic ExerciseParticipants 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 | Behavioural | Exercise prehabilitation |
| Optional Aerobic Exercise ProcedureParticipants 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. | Behavioural | Exercise prehabilitation |
| Optional In-Person Exercise SessionsParticipants 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. | Radiation | Exercise prehabilitation |
Primary outcome
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
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
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
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.
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
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.
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.
Participant Skeletal Muscle Index (SMI) - Baseline
Time frame: Baseline
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Parker, PhD, MPH principal investigator
Moffitt Cancer Center
Ciara Freeman, MD, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training, Aerobic Exercise and Optional Aerobic Exercise Procedure in people with Lymphoma and Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants that Enroll and Consent - Enrollment Feasibility (time frame: Up to 12 Months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.