Effects of Exercise on Patient Reported Outcomes in Newly Diagnosed Adults With Acute Leukemia During Induction Treatment: Exercise and Quality of Life in Leukemia Patients (EQUAL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Compare symptoms of fatigue in newly diagnosed acute leukemia patients
研究概览
简要总结
The purpose of this study is to evaluate the impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances among acute leukemia patients. The investigators hypothesize that exercise will reduce fatigue in acute leukemia patients.
详细描述
The purpose of this randomized, prospective, longitudinal study is to evaluate the impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances outcomes among acute leukemia patients. The study will include 2 groups for a total sample size of 30: n=15 control group and n=15 intervention group. Each patient enrolled in the intervention arm will participate in an exercise program for the duration of their hospitalization, 4-6 weeks on average during the first treatment (induction chemotherapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with acute leukemia by pathology report
- •Admitted for induction chemotherapy within in the previous 96 hours or +/- 3 days from initiation of induction chemotherapy
- •An expected hospital stay of 3-4 weeks or longer
- •Participation in the study must be approved by the physician directly responsible for the patient's care while at University of North Carolina -Hospitals
- •Age >21 years of age
- •Willing and able to provide, signed informed consent
- •Willing and able to use a computer to complete study questionnaires
- •Ability to understand and speak English
排除标准
- •The criteria below will be determined by the patient's physician and a review of the patient's medical history. If any of the exclusion criteria are observed, the patients will be informed and excluded from participating in the study.
- •Participation in this study will involve the same risks as any exercise regimen. Given the potential risks involved, patients will be screened for exclusion based upon the following criteria:
- •Cardiovascular disease (unless the disease would not compromise the patient's ability to participate in the exercise rehabilitation program)
- •Acute or chronic respiratory disease that would compromise the patient's ability to participate in the exercise rehabilitation program
- •Acute or chronic bone, joint, or muscular abnormalities that would compromise the patient's ability to participate in the exercise rehabilitation program
- •Inability to understand and speak English
- •Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
- •Another active malignancy
- •Patients will also be excluded if they have active bleeding, acute thrombosis, ischemia, hemodynamically unstable, and uncontrolled pain.
结局指标
主要结局
Compare symptoms of fatigue in newly diagnosed acute leukemia patients
时间窗: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Symptoms will be assessed by patient reported survey at baseline, weekly through patient hospitalization, and then again at patient's first appointment after hospital discharge. We are interested in how the symptom changes over time.
次要结局
- Changes in muscle strength(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Compare symptoms of depression between groups(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Compare sleep quality between groups(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Changes in cardiovascular function(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Evaluate health-related quality of life changes over time(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Compare symptoms of anxiety between groups(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Changes in body composition(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Changes in functional mobility(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Changes in muscle size(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)