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

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinic-based physical therapy program.
Home exercise program.
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Fatigue, Cancer-related fatigue, High grade glioma, Quality of life, Exercise, Physical Therapy, HGG, QOL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Physical Therapy

Home Exercise

Arm Description

Outcomes

Primary Outcome Measures

Determine the effect of a 6-week Physical Therapist-directed home exercise program on the pattern of patient reported fatigue.

Secondary Outcome Measures

Determine the effect of a 6-week Physical Therapist-directed home exercise program on the severity of patient reported fatigue.
Determine the effect of a 6-week Physical Therapist-directed home exercise program on routine quality of life measurements and outcome.

Full Information

First Posted
February 6, 2009
Last Updated
July 10, 2012
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00840554
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Fatigue, Cancer-related fatigue, High grade glioma, Quality of life, Exercise, Physical Therapy, HGG, QOL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Title
Home Exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Clinic-based physical therapy program.
Other Intervention Name(s)
PT
Intervention Description
All patients will receive a routine clinic-based physical therapy program. This program may include supervised aerobic conditioning, strengthening exercise, balance retraining, functional activity training, therapeutic exercise, and manual therapy.
Intervention Type
Other
Intervention Name(s)
Home exercise program.
Other Intervention Name(s)
Exercise
Intervention Description
In addition to the clinic-based physical therapy program, patients will perform home exercises. Home exercise will include a walking and strengthening program 5 days per week. The home exercise routine will be recorded in an exercise diary.
Primary Outcome Measure Information:
Title
Determine the effect of a 6-week Physical Therapist-directed home exercise program on the pattern of patient reported fatigue.
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Determine the effect of a 6-week Physical Therapist-directed home exercise program on the severity of patient reported fatigue.
Time Frame
6 Weeks
Title
Determine the effect of a 6-week Physical Therapist-directed home exercise program on routine quality of life measurements and outcome.
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin M Dunbar, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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

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