NCT00840554

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 11, 2012

Status Verified

July 1, 2012

Enrollment Period

2.8 years

First QC Date

February 6, 2009

Last Update Submit

July 10, 2012

Conditions

Fatigue

Keywords

FatigueCancer-related fatigueHigh grade gliomaQuality of lifeExercisePhysical TherapyHGGQOL

Outcome Measures

Primary Outcomes (1)

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

    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.

    6 Weeks

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

    6 Weeks

Study Arms (2)

Physical Therapy

ACTIVE COMPARATOR
Other: Clinic-based physical therapy program.

Home Exercise

EXPERIMENTAL
Other: Home exercise program.

Interventions

Clinic-based physical therapy program.OTHER

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
Physical Therapy
Home exercise program.OTHER

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
Home Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

FatigueGliomaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Erin M Dunbar, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 10, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 11, 2012

Record last verified: 2012-07

Locations

US(1)