Exercise and Quality of Life in Leukemia Patients

NCT ID: NCT02246907

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Leukemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Health related quality of life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise

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

Group Type OTHER

Exercise

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Exercise and Quality of Life in Acute Leukemia Patients

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ashley Bryant, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

UNC- Chapel Hill

Claudio Battaglini, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC- Chapel Hill

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of North Carolina Lineberger Comprehenisive Cancer Center

Chapel Hill, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LCCC1234

Identifier Type: -

Identifier Source: org_study_id