Exercise and Quality of Life in Leukemia Patients

NCT02246907 | Completed DMC

• 1 other identifier: LCCC1234
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Leukemia

Keywords

Health related quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

Study Arms (2)

Control Group

NO INTERVENTION

The control group will receive standard of care which includes recreational therapy and standard encouragement.

Exercise

OTHER

Participants in this arm will receive standard of care plus exercise for the duration of their inpatient stay for induction chemotherapy.

Other: Exercise

Interventions

Exercise OTHER

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.

Also known as: Exercise and Quality of Life in Acute Leukemia Patients

Exercise

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina Lineberger Comprehenisive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Exercise; Quality of Life

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ashley Bryant, PhD, RN

  UNC- Chapel Hill

  PRINCIPAL INVESTIGATOR

• Claudio Battaglini, PhD

  UNC- Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: September 23, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 23, 2016

Record last verified: 2016-11

Locations

US (1)