Prehabilitation With Aerobic and Resistance Exercise for Improving Physical Fitness and Quality of Life Outcomes in Older Patients Undergoing CAR-T Therapy for Relapsed or Refractory Multiple Myeloma

Enrollment rate

Enrollment rate will be evaluated as the number of patients eligible versus the number of patients enrolled.

Time frame: Up to 1 year

Retention rate

Retention rate will be evaluated as the proportion of enrolled patients who complete assessments at visit 2 (at 2 days prior to CAR-T infusion) and visit 3 (30 days post-CAR-T infusion).

Time frame: Up to 30 days post-chimeric antigen receptor (CAR)-T infusion

Program completion

Will be evaluated according to the completion of weekly phone calls, the frequency, intensity, and duration of exercise engagement, and accelerometer summary outcomes. The program will be considered feasible if there is \> 70% program completion, based on weekly phone calls.

Time frame: Up to 30 days post-CAR-T infusion

Incidence of adverse events

The program will be considered feasible if there are no serious adverse events due to the intervention.

Time frame: Up to 30 days post-CAR-T infusion

Patient satisfaction

Patient satisfaction will be determined using post-program satisfaction phone interviews. Qualitative interviews will be analyzed using thematic analysis.

Time frame: Up to 30 days post-CAR-T infusion

Change in muscle strength

Assessed as grip strength, as measured (in kg) by maximal force generated by forearm muscles using calibrated handheld dynamometer

Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)

Change in muscle mass

Assessed via SOZO by ImpediMed \[bioimpedance spectroscopy (BIS)\] and Positron Emission Tomography (PET) Computed Tomography (CT) CT scan images, obtained as part of the patient's usual care.

Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)

Change in physical performance

Assessed via short physical performance test (approximately 90 minutes) followed by wearing an activity monitor (Actigraph) for 7 days following each of 3 in-person physical assessments. Participants receive a postage-paid envelope to return the monitor after wearing it.

Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)

Change in quality of life - EORTC QLQ-C30

Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, a 30-item questionnaire where 28 questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much) and 2 two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life.

Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)

Change in physical activity - monitor

Assessed using Polar heart rate monitor with data collected through the Connected mHealth app.

Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)

Change in physical activity - RPE Scale

Assessed using patient self-reported Rate of Perceived Exertion (RPE) scale score within the Connected mHealth app after exercise: 1=very light activity; 2-3=light activity; 4-5=moderate activity; 7-8=vigorous activity; 9=very hard activity; and 10=maximal effort.

Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)

Changes in frailty status - IMWG-FI

Assessed using International Myeloma Working Group (IMWG) Frailty Index (FI) scores. The IMWG-FI assigns scores based on age, comorbidities, and the ability to perform activities of daily living (ADL) and instrumental activities of daily living (IADL). Patients are categorized as follows: Fit: Score of 0; Intermediate-fit: Score of 1; Frail: Score of 2 or higher.

Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)

Changes in frailty status - FP

The Fried frailty phenotype (FP) defines frailty as the presence of three or more of the following: unintentional weight loss ≥10 lb in previous year; self-reported exhaustion; weakness measured by grip strength; slow walking speed ;and low physical activity (less than 3 days of physical activity per week defined by the Department of Health Services \& Human Services). The presence of: 1) ≥3 criteria indicates frail status, 2) 1 or 2 criteria indicates intermediate or pre-frail status, and 3) 0 criteria indicates robust status.

Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)