Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2014-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control Group
The control group will receive standard of care which includes recreational therapy and standard encouragement.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
ALL
No
Sponsors
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UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ashley Bryant, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
UNC- Chapel Hill
Claudio Battaglini, PhD
Role: PRINCIPAL_INVESTIGATOR
UNC- Chapel Hill
Locations
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University of North Carolina Lineberger Comprehenisive Cancer Center
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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LCCC1234
Identifier Type: -
Identifier Source: org_study_id