View Clinical Trial (Medical Research Study)
Self-Regulated Exercise in CF: A Randomized Trial
| City: |
|
Pittsburgh |
| State: |
|
Pennsylvania |
| Zip Code: |
|
15213 |
| Conditions: |
|
Cystic Fibrosis - Self Regulated Exercise |
| Purpose: |
|
The aim of this study is to test the effect of a 6-month program of self-regulated,
home-based exercise with telephone reinforcement on the cardiorespiratory fitness, pulmonary
function and health-related quality of life of children with cystic fibrosis (CF), compared
to controls. Exploring the exercise experiences of the children and parents is a secondary
aim.
|
| Study Summary: |
|
CF is a life-long illness that requires complex and dynamic adjustment by the patient and
family. The nursing role is vital to the multidisciplinary team approach required in
providing comprehensive, individualized care for these patients. Nurses facilitate the
coordination of health care efforts and support the patient and family across physical and
psychosocial domains. With the well-documented correlation between exercise tolerance and
both survival and HRQoL, exercise represents a critical treatment focus for CF patients.
Nurses contribute to standard exercise rehabilitation programs, through education,
psychosocial support, and communication. In this exercise training study, the nursing role
will include: a) teaching the patients and families how to use the OMNI scale, b) confirming
that they understand the home-based exercise regimen, and c) ensuring that the home-care
program is properly followed by placing weekly telephone calls to assess progress and
barriers. Long-term nursing application will occur via dissemination of the OMNI training
manual, to be developed as part of this study, for use by CF nurses in clinics worldwide.
|
| Criteria: |
|
Inclusion Criteria:
- CF diagnosis
- age 10-18 years
- reliable pulmonary function tests
- living at home
- able to read
- able to ride a stationary bike
- able to walk and/or run on a treadmill.
Exclusion Criteria:
- Enrolled in another intervention study
- in structured aerobic activity for 30 continuous minutes 3 times per week
- sibling enrolled in study.
|
| NCT ID: |
|
NCT00609050 |
| Primary Contact: |
|
Principal Investigator David M Orenstein, MD Children's Hospital of Pittsburgh
Linda W Higgins, PhD, RN Phone: 412-692-5872 Email: linda.higgins@chp.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Pittsburgh, Pennsylvania 15213 United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 21, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|