FatigueNCT00840554
The Effects of Adding a Home Exercise Program to a Clinical Physical Therapy Program on Cancer-Related Fatigue
A study testing Clinic-based physical therapy program. and Home exercise program. in people with Fatigue, run by University of Florida at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue
- What is being tested?
- Clinic-based physical therapy program. and Home exercise program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Fatigue
- Being tested
- Clinic-based physical therapy program., Home exercise program.
- Keywords
- Fatigue, Cancer-related fatigue, High grade glioma, Quality of life, Exercise, Physical Therapy, HGG, QOL
- Medical subject headings
- Fatigue, Glioma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic-based physical therapy program.Other
Also called PT
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.
Home exercise program.Other
Also called Exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy | Active comparator | Not described Receives: Other: Clinic-based physical therapy program. |
| Home Exercise | Experimental | Not described Receives: Other: Home exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of a 6-week Physical Therapist-directed home exercise program on the pattern of patient reported fatigue.
Measured: 6 Weeks
Secondary outcomes (2)
Determine the effect of a 6-week Physical Therapist-directed home exercise program on the severity of patient reported fatigue.
Measured: 6 Weeks
Determine the effect of a 6-week Physical Therapist-directed home exercise program on routine quality of life measurements and outcome.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin M Dunbar, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840554
- Sponsor's protocol ID
- HEP-001
- Status last verified
- Jul 2012
- First submitted
- 6 Feb 2009
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00840554
- Acronym / sponsor ID
- HEP-001
- Conditions
- Fatigue
- Keywords
- Fatigue, Cancer-related fatigue, High grade glioma, Quality of life, Exercise, Physical Therapy, HGG, QOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy | Active comparator | Other: Clinic-based physical therapy program. |
| Home Exercise | Experimental | Other: Home exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Adequate medical health to participate in this study.
Key exclusion criteria (6 listed)
- Failure to meet inclusion criteria
- Physical and medical issues that would interfere with trial participation, such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinic-based physical therapy program.Also: PTAll 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 | Physical Therapy |
| Home exercise program.Also: ExerciseIn 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 | Home Exercise |
Primary outcome
Determine the effect of a 6-week Physical Therapist-directed home exercise program on the pattern of patient reported fatigue.
Time frame: 6 Weeks
2 secondary outcomes
Determine the effect of a 6-week Physical Therapist-directed home exercise program on the severity of patient reported fatigue.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin M Dunbar, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic-based physical therapy program. and Home exercise program. in people with Fatigue, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the effect of a 6-week Physical Therapist-directed home exercise program on the pattern of patient reported fatigue. (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.