Exercise and Quality of Life in Leukemia Patients (EQUAL)

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)

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.

Study Overview

• Status: Completed
• Conditions: Acute Leukemia
• Intervention / Treatment: Other: Exercise

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Lineberger Comprehenisive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The control group will receive standard of care which includes recreational therapy and standard encouragement.
Other: Exercise; Participants in this arm will receive standard of care plus exercise for the duration of their inpatient stay for induction chemotherapy.	Other: Exercise; All intervention patients will participate in an individualized prescriptive exercise intervention 2 to 4 times per week for a period of the induction chemotherapy/in-hospital recovery. The exercise intervention will begin on week 1 of the study, the day after the first batteries of initial assessments are concluded. Each exercise session will be divided into two parts. One part will be administered in the morning and the second one late in the afternoon. There will be a period of rest of at least 36 hours between each exercise session.; Other Names: Exercise and Quality of Life in Acute Leukemia Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare symptoms of fatigue in newly diagnosed acute leukemia patients	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.	participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate health-related quality of life changes over time	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	participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Compare symptoms of anxiety between groups	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.	participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Compare symptoms of depression between groups	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.	participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Compare sleep quality between groups	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.	participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in cardiovascular function	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.	participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in muscle strength	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.	participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in body composition	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.	participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in functional mobility	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.	participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in muscle size	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.	participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Ashley Bryant, PhD, RN, UNC- Chapel Hill; Principal Investigator: Claudio Battaglini, PhD, UNC- Chapel Hill

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 23, 2014

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Health related quality of life
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: LCCC1234