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)
18 Years
N/A
Both
Fatigue
Trial Information
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)
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-related fatigue remains poorly understood and poorly treated by the
worldwide medical community.
The physical and emotional impact of cancer-related fatigue on Activities of Daily Living
and Independent Activities of Daily Living can be profound. Simple tasks such as preparing
meals and performing household chores become laborious. Walking up and down the aisles of
grocery stores may send a patient directly to bed for the rest of the day upon returning
home. In addition, if cancer-related fatigue contributes to prolonged bed rest, the
secondary development of other medical problems can further impact quality of life and
possibly length of life. Furthermore, the economic impact of cancer-related fatigue includes
patients taking more days off work and reducing the number of hours they are able to work.
Lastly, cancer-related fatigue often impacts the psychosocial well-being and family dynamics
of patients, caregivers and their families.
Exercise is the strongest non-pharmacological intervention for management of cancer-related
fatigue. Certain exercises have specifically demonstrated reduction in fatigue. An exercise
program that incorporates strengthening and aerobic conditioning can decrease fatigue
scores. Improvements in patient-reported cancer-related fatigue through the use of exercise
has been demonstrated in various diseases, such as anemia, and several cancer types, most
notably breast cancer. Furthermore, home exercise programs have shown meaningful
improvements in patient reported fatigue.
This study will determine the effect that the addition of a 6-week Physical
Therapist-directed home exercise program has on the pattern, severity, and quality of life
of patient reported fatigue.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Outcome Measure:
Determine the effect of a 6-week Physical Therapist-directed home exercise program on the pattern of patient reported fatigue.
Outcome Time Frame:
6 Weeks
Safety Issue:
No
Principal Investigator
Erin M Dunbar, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Florida
Authority:
United States: Institutional Review Board
Study ID:
HEP-001
NCT ID:
NCT00840554
Start Date:
February 2009
Completion Date:
December 2011
Related Keywords:
- Fatigue
- Fatigue
- Cancer-related fatigue
- High grade glioma
- Quality of life
- Exercise
- Physical Therapy
- HGG
- QOL
- Fatigue
Name | Location |
|---|---|
| University of Florida | Gainesville, Florida 32610-0277 |
