Feasibility Of Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For Chimeric Antigen Receptor (CAR) T-Cell Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Objective physical functioning and fitness - Follow-up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Objective physical functioning and fitness - Follow-up
时间窗: 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.
Objective physical functioning and fitness - Baseline
时间窗: 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.
Participant Evaluation of Feasibility and Acceptability - Acceptability
时间窗: 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.
Adherence - Feasibility
时间窗: 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 Skeletal Muscle Index (SMI) - Baseline
时间窗: Baseline
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Participant Self Reported Exercise - At 3 Months
时间窗: 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
时间窗: 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
Participant Self-Reported Musculoskeletal Injuries - Safety
时间窗: 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
Participants Health-Related Quality of Life - Baseline
时间窗: Baseline
Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Participant Skeletal Muscle Index (SMI) - Follow-up
时间窗: After CAR-T Therapy, Up to 6 Months
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Participant Self Reported Exercise - Baseline
时间窗: Baseline
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Percentage of Participants that Enroll and Consent - Enrollment Feasibility
时间窗: 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
时间窗: Up to 3 Months
Retention will be considered feasible if ≥70% of participants complete study measures
Participants Health-Related Quality of Life - At 3 Months
时间窗: 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
时间窗: Up to 6 Months
Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
次要结局
未报告次要终点