Clinical trial · Interventional
The Effects of Adding a Home Exercise Program to a Clinical Physical Therapy Program on Cancer-Related Fatigue
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)
NCT00840554CI-TRIAL-00007369completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinic-based physical therapy program. | Other | — | UNRESOLVED |
| Home exercise program. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Physical Therapy
- interventionNames
- Other: Clinic-based physical therapy program.
- type
- EXPERIMENTAL
- label
- Home Exercise
- interventionNames
- Other: Home exercise program.
Primary outcomes (1)
- 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 (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.