Fatigue Clinical Trial
Official title:
The Effects of Adding a Home Exercise Program (HEP) to a Clinical Physical Therapy Program (CPTP) on the Cancer-Related Fatigue Reported by Patients Undergoing Concurrent Radiation and Chemotherapy for High-Grade Glioma (HGG)
Verified date | July 2012 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 chemotherapy and radiation therapy for high grade gliomas.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Greater than 18 years old on day of enrollment, male or female. 2. 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. 3. Patients otherwise meeting standard medical criteria for referral to physical therapy. 4. Physically capable of trial participation, defined as: - Ambulatory, without assist-devices. - Able to maintain a specified walking pace for 15-30 minutes. 5. Adequate medical health to participate in this study. 6. Absence of factors that have been documented to possibly confound the assessment of fatigue: - Hematocrit (Hct) <30. - Thyroid Stimulating Hormone (TSH) > 2.5 wnl. 7. Absence of other factors, such as inadequate nutritional level, pain control, electrolyte levels, depression, that are felt insufficient for trial participation. 8. Karnofsky Performance Status >60 or ECOG Performance Status <2. 9. Ability to read and understand the patient informed consent form. 10. 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. 11. Signed informed consent. Exclusion Criteria: 1. Failure to meet inclusion criteria 2. 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the effect of a 6-week Physical Therapist-directed home exercise program on the pattern of patient reported fatigue. | 6 Weeks | No | |
Secondary | Determine the effect of a 6-week Physical Therapist-directed home exercise program on the severity of patient reported fatigue. | 6 Weeks | No | |
Secondary | Determine the effect of a 6-week Physical Therapist-directed home exercise program on routine quality of life measurements and outcome. | 6 Weeks | No |
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