The Effects of Adding a Home Exercise Program to a Clinical Physical Therapy Program on Cancer-Related Fatigue

Completed · Not applicable

Conditions studied: Fatigue

In brief

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.

Key facts

Study ID

NCT00840554

Run by

University of Florida

People needed

20

Starts

2009-02-01

Expected to finish

2011-12-01

Last updated by the study team

2012-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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