Exercise and Quality of Life in Leukemia Patients

Not Applicable

Completed

• Conditions: Acute Leukemia

• Registration Number: NCT02246907
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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).

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-23
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare symptoms of fatigue in newly diagnosed acute leukemia patients	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 Outcome Measures

Name	Time	Method
Changes in muscle strength	participants will be followed for the duration of hospital stay, an expected average of 6 weeks	Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
Compare symptoms of depression between groups	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 during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.
Compare sleep quality between groups	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 during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.
Changes in cardiovascular function	participants will be followed for the duration of hospital stay, an expected average of 6 weeks	Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
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	Health related quality of life will be assessed by patient reported survey at baseline, and at the week 4 timepoint. We are interested in change over time between groups
Compare symptoms of anxiety between groups	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 during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.
Changes in functional mobility	participants will be followed for the duration of hospital stay, an expected average of 6 weeks	Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
Changes in muscle size	participants will be followed for the duration of hospital stay, an expected average of 6 weeks	Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
Changes in body composition	participants will be followed for the duration of hospital stay, an expected average of 6 weeks	Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.

Trial Locations

Locations (1)

University of North Carolina Lineberger Comprehenisive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States