Status:
COMPLETED
The Effects of Adding a Home Exercise Program to a Clinical Physical Therapy Program on Cancer-Related Fatigue
Lead Sponsor:
University of Florida
Conditions:
Fatigue
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to find out if adding a home exercise program to a clinic physical therapy program will improve the fatigue experienced by patients being treated with concurrent chemother...
Detailed Description
Cancer-related fatigue is a common and disabling symptom in patients undergoing outpatient therapies to treat their cancers. Despite a consistent increase in both awareness and research, cancer-relate...
Eligibility Criteria
Inclusion
- Greater than 18 years old on day of enrollment, male or female.
- Histological confirmation of a high grade glioma (HGG). The patient's treatment plan must include plans for concurrent radiation and chemotherapy at the University of Florida.
- Patients otherwise meeting standard medical criteria for referral to physical therapy.
- Physically capable of trial participation, defined as:
- Ambulatory, without assist-devices.
- Able to maintain a specified walking pace for 15-30 minutes.
- Adequate medical health to participate in this study.
- Absence of factors that have been documented to possibly confound the assessment of fatigue:
- Hematocrit (Hct) \<30.
- Thyroid Stimulating Hormone (TSH) \> 2.5 wnl.
- Absence of other factors, such as inadequate nutritional level, pain control, electrolyte levels, depression, that are felt insufficient for trial participation.
- Karnofsky Performance Status \>60 or ECOG Performance Status \<2.
- Ability to read and understand the patient informed consent form.
- Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed, and completion of all diaries and forms.
- Signed informed consent.
Exclusion
- Failure to meet inclusion criteria
- Physical and medical issues that would interfere with trial participation, such as:
- History of major cardiopulmonary symptoms.
- Orthopedic problem limiting participation.
- Dementia or poor mental status.
- Neurological deficit limiting participation physically or cognitively.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00840554
Start Date
February 1 2009
End Date
December 1 2011
Last Update
July 11 2012
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610