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Chapel Hill, North Carolina 27599


Purpose:

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 summary:

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).


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.


NCT ID:

NCT02246907


Primary Contact:

Principal Investigator
Ashley Bryant, PhD, RN
UNC- Chapel Hill


Backup Contact:

N/A


Location Contact:

Chapel Hill, North Carolina 27599
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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