Implementation of a Physician-prescribed Exercise Program as Standard of Care in Allogeneic Stem Cell Transplant Patients in British Columbia: a Pilot Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quality of Life
研究概览
简要总结
This study is a preliminary study to assess whether it is possible to introduce an exercise program for BMT patients after discharge from hospital. The exercise program will include 3 endurance (stationary bike, walking) and 2 resistance (weights, stretch bands) training sessions/week, until 100 days after BMT. Our second plan is to test changes in QoL, aerobic fitness, muscle strength, total body fat and mineral composition, and blood immune markers with exercise in the 100 days after BMT. The investigators anticipate this study will improve the QoL, mobility, and strength of patients after BMT, therefore allowing a faster and healthier recovery.
详细描述
PURPOSE: Our long-term goal is to conduct a randomized clinical trial to investigate whether a physician-prescribed supervised exercise intervention in allogeneic stem cell transplant (alloHSCT) patients within the Leukemia/Bone Marrow Transplant (LBMT) Program of BC results in improved QoL compared to no intervention. This current study is a pilot study with the primary aim of determining the feasibility, including recruitment, retention, and adherence, of delivering such an intervention as standard of care.
HYPOTHESES:
- The physician-prescribed exercise intervention will be feasible in terms of recruitment (goal of 20 patients recruited over study period), retention (≥70%), and adherence (≥70%) of participants.
- The intervention will be safe and highly acceptable to participants.
JUSTIFICATION: Allogeneic hematopoeitic stem cell transplantation (alloHSCT) is used to treat malignant and non-malignant hematopoeitic diseases including leukemia, lymphoma, and bone marrow failure syndromes. Recent advances in alloHSCT have led to improved relapse-free and overall survival (OS); however alloHSCT remains associated with significant morbidity including chronic graft-versus-host disease (GVHD), infectious and immune complications, reduced physical performance and functioning due to deconditioning, sarcopenia, and bone loss, and particularly high levels of fatigue and psycho-social stress, all of which negatively impact patients' quality of life (QoL). There is an accumulating body of evidence emphasizing that physical activity (PA) may be one modifiable lifestyle factor that has the potential to positively influence QoL, physical functioning and other health-related outcomes in HSCT survivors. Currently alloHSCT patients in Canada, including in BC, have little access to exercise programs that address the unique barriers within this population, particularly during the early post-transplant period where the need is greatest. These include concerns about using a public gym due to an immunocompromised state, supervision by trained professionals, and ability to exercise with low blood counts and other post-transplant complications.
OBJECTIVES:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years of age
- •Undergoing alloHSCT for any indication through the LBMT Program of BC at VGH
- •Good comprehension of English (must be able to fill out questionnaires in English)
排除标准
- •Contraindications to entrance into an exercise program (i.e., known cardiovascular disease, musculoskeletal issue or not cleared for exercise by the attending physician)
- •Mobility impairment requiring use of mobility aids
结局指标
主要结局
Quality of Life
时间窗: Approximately 12-weeks
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
次要结局
- Immune Function(Approximately 12-weeks)
- Baseline Demographics(Baseline: pre-BMT visit.)
- Body Composition(Approximately 12-weeks)
- Aerobic Fitness(Approximately 12-weeks)
- Muscle Strength(Approximately 12-weeks)