The Effects of a Prehabilitation Exercise Program in Adults Receiving a Hematopoietic Stem Cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Feasibility of the exercise intervention: 50% of included patients actually complete at least one third of the exercise sessions
研究概览
简要总结
The purpose of this study is to determine whether patients are able to participate in a prehabilitation program (prior to the beginning of treatment) which includes: (1) a home-based exercise program or (2) just a prehabilitation education session.
详细描述
Hematopoietic stem cell transplant may have the potential for severe side effects, including functional (reduced aerobic capacity, reduced muscle strength) and psychosocial (e.g. reduced quality of life, increased fatigue) detriments.
Evidence shows that exercise is considered to be an effective treatment approach in hematopoietic stem cell transplant patients during and after treatment with regard to the above mentioned side-effects. Also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and effective. However, no experience exists with regard to prehabilitation exercise in hematopoietic stem cell transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Hematological cancer (e.g. Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Myeloma, Non-Hodgkin Lymphoma, etc.)
- •Hematological cancer in remission
- •Females and males ≥18 years of age
- •Fluent in written and spoken English
- •Must be able to provide and understand informed consent
- •Must have an ECOG score of ≤ 2
- •Scheduled for an inpatient autologous or allogeneic stem cell transplant at Penn State Cancer Institute
- •≥ 2 weeks until scheduled transplant
- •Primary attending physician approval
排除标准
- •Hematological cancer not in remission
- •Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency > NYHA III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability) for exercise
- •Any other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist
- •Uncontrolled hypertension
- •Receiving non-transplant related chemotherapy and/or radiotherapy
- •Not fluent in written and spoken English
- •Active infections, hemorrhages, and cytopenias that could place transplant patients at risk for further adverse events, deemed by the exercise interventionist, physician and/or nurse
结局指标
主要结局
Feasibility of the exercise intervention: 50% of included patients actually complete at least one third of the exercise sessions
时间窗: Through study completion, an average of 18 months
The exercise intervention will be considered feasible if 50% of included patients actually complete at least one third of the exercise sessions prescribed for 2 weeks or more.
Safety of the exercise intervention: questionnaire
时间窗: Through the study completion, an average of 18 months
Within the questionnaire we will assess whether musculoskeletal occur (yes/no; ongoing; location; severity (mild-life threatening); daily activities affected). The intervention will be considered as safe if less than 25% of included patients report mild musculoskeletal impairments and less than 5% experienced musculoskeletal injuries (defined as symptoms lasting a week or longer and or requiring the attention of a medical professional).
Acceptability of the exercise intervention: more than 50% of the patients approached
时间窗: During recruitment
The exercise intervention will be considered acceptable if more than 50% of the patients approached agree to receive at least the first exercise session.
次要结局
- Health-related Quality of Life: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0)(Through study completion, an average of 18 months)
- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events(Through study completion, an average of 18 months)
- Physical Function: Timed-Up-and-Go Test(Through study completion, an average of 18 months)
- Fatigue(Through study completion, an average of 18 months)
- Sleep(Through study completion, an average of 18 months)
- Depression(Through study completion, an average of 18 months)
- Bone Marrow Transplant-related Quality of Life: EORTC QLQ-HDC29(Through study completion, an average of 18 months)
- Short Questionnaire to Assess Health-Enhancing Physical Activity(Through study completion, an average of 18 months)
- Godin Physical Activity Questionnaire(Through study completion, an average of 18 months)
- Body Pain: Brief Pain Inventory- Short form(Through study completion, an average of 18 months)
- Fall Risk(Through study completion, an average of 18 months)
- Physical Function: Short Physical Performance Battery(Through study completion, an average of 18 months)
- Aerobic Capacity: Six Minute Walk Test(Through study completion, an average of 18 months)
研究者
Shin Mineishi
Professor, Public Health Science
Milton S. Hershey Medical Center