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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Leukemia
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Compare symptoms of fatigue in newly diagnosed acute leukemia patients
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Compare symptoms of fatigue in newly diagnosed acute leukemia patients
Time Frame: 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.
Secondary Outcomes
- 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)