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

July 10, 2012 updated by: University of Florida

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physical Therapy
Other: Clinic-based physical therapy program.
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.
Other Names:
  • PT
Experimental: Home Exercise
Other: Home exercise program.
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.
Other Names:
  • Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the effect of a 6-week Physical Therapist-directed home exercise program on the pattern of patient reported fatigue.
Time Frame: 6 Weeks
6 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the effect of a 6-week Physical Therapist-directed home exercise program on the severity of patient reported fatigue.
Time Frame: 6 Weeks
6 Weeks
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
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

July 11, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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