NCT05649371尚未招募不适用
A Multiphasic Prehabilitation Exercise Program For Allogeneic Hematopoietic Stem Cell Transplant Recipients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Feasibility of Implementing an Exercise Program for Patients Undergoing Allogeneic-HSCT, Measured by Participant Attendance
研究概览
简要总结
The purpose of this study is to implement a prehabilitation intervention to enhance recovery for people undergoing allogeneic stem cell transplant for hematologic malignancies. All participants in this study will receive a prehabilation intervention in addition to usual care (no change to their chemotherapy protocols or transplant) and several quality of life and fitness scores will be measured throughout the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 18 years or older, undergoing an allo-HSCT for acute leukemia.
- •Approval to engage in exercise as per screening by the CSEP or ACSM certified CEP and/or clinician
- •Ability to provide written informed consent and understand study information.
排除标准
- •Less than 18 years old
- •Diagnosed with acute leukemia but not undergoing work-up for allo-HSCT
- •Unable to read/communicate in English (i.e., unable to complete experimental procedures such as patient-reported outcomes).
- •Neurological or musculoskeletal comorbidity inhibiting exercise.
- •Diagnosed psychotic, addictive, or major cognitive disorders.
- •Severe coronary artery disease (Canadian Cardiovascular Society class III or greater).
- •Significant congestive heart failure (New York Heart Association class III or greater).
- •Severe thrombocytopenia (platelets <10) - ok if transfused platelets prior to exercise.
结局指标
主要结局
Feasibility of Implementing an Exercise Program for Patients Undergoing Allogeneic-HSCT, Measured by Participant Attendance
时间窗: 6-9 months
Review participant attendance/participation in the program and the questionnaires.
次要结局
- Amount of Physical Activity Measured With Activity Tracker(6-9 months)
- Exercise Behaviour Measured with Modified Godin Leisure Time Exercise Questionnaire(6-9 months)
- Patient Quality of Life Measured with the Functional Assessment of Cancer Therapy-Bone Marrow Transplant and EuroQol 5 Dimension 5 Level Questionnaire(6-9 months)
- Level of Fatigue Measured with the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) Questionnaire(6-9 months)
- Amount of Anxiety and depression Measured with the Hospital Anxiety and Depression Scale (HADS) Questionnaire(6-9 months)
- Amount of Symptom burden Measured with the Edmonton Symptom Assessment System-revised (ESAS-r) Questionnaire(6-9 months)
- Patient's Performance Status Measured by the Eastern Cooperative Oncology Group (ECOG) Scale(6-9 months)
- Handgrip Strength Measured by Handgrip Dynamometry(6-9 months)
- Balance Measured by Single Leg Stance Test(6-9 months)
- Lower Limb Muscular Endurance Measured with 30-second sit-to-stand Test(6-9 months)
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