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CompletedNCT00840554Updated Jul 11, 2012

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

An interventional study of Clinic-based physical therapy program. and Home exercise program. in Fatigue, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-11.

Sponsored by University of Florida · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fatigue

Keywords

  • Fatigue
  • Cancer-related fatigue
  • High grade glioma
  • Quality of life
  • Exercise
  • Physical Therapy
  • HGG
  • QOL
03

In context

Fatigue

1,912 studies on the registry are indexed under Fatigue; 381 are open to participants now.

This study's enrollment of 20 is below the median of 53 across 1,479 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.

Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Physical Therapy

    Other: Clinic-based physical therapy program.

  • Experimental
    Home Exercise

    Other: Home exercise program.

Interventions

  • OtherClinic-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.

    Also known as: PT

  • OtherHome 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.

    Also known as: Exercise

06

What researchers measure

Primary outcomes

  1. 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 outcomes

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

    Time frame: 6 Weeks

  2. 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

07

Study locations

1 site
  • University of Florida
    Gainesville, Florida 32610, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2009, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2009
First posted
Feb 10, 2009
Start
Feb 2009
Primary completionActual
Dec 2011
CompletionActual
Dec 2011
Last update
Jul 11, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00840554
Responsible party
Sponsor
First posted
Feb 10, 2009
Start date
Feb 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Jul 11, 2012

Study contacts

Erin M Dunbar, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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