Clinical trial NCT00840554: The Effects of Adding a Home Exercise Program to a Clinical Physical Therapy Program on Cancer-Related Fatigue
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: Fatigue
Cancer-related fatigue
High grade glioma
Quality of life
Exercise
Physical Therapy
HGG
QOL
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 chemotherapy and radiation therapy for high grade gliomas.

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-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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the effect of a 6-week Physical Therapist-directed home exercise program on the pattern of patient reported fatigue.
timeFrame: 6 Weeks
Secondary outcomes:
measure: Determine the effect of a 6-week Physical Therapist-directed home exercise program on the severity of patient reported fatigue.
timeFrame: 6 Weeks
measure: Determine the effect of a 6-week Physical Therapist-directed home exercise program on routine quality of life measurements and outcome.
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Erin M Dunbar, MD
role: PRINCIPAL_INVESTIGATOR
References: