Clinical trial NCT02246907: Exercise and Quality of Life in Leukemia Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Leukemia
Keywords: Health related quality of life
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-09-23
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Compare symptoms of fatigue in newly diagnosed acute leukemia patients
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary outcomes:
measure: Evaluate health-related quality of life changes over time
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Compare symptoms of anxiety between groups
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Compare symptoms of depression between groups
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Compare sleep quality between groups
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Changes in cardiovascular function
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Changes in muscle strength
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Changes in body composition
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Changes in functional mobility
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Changes in muscle size
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Lineberger Comprehenisive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC- Chapel Hill
name: Ashley Bryant, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC- Chapel Hill
name: Claudio Battaglini, PhD
role: PRINCIPAL_INVESTIGATOR
References: