Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-25 @ 2:41 PM
Study NCT ID:
NCT00609050
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2008-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Training Study for Patients With Cystic Fibrosis
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Self-Regulated Exercise in CF: A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01NR009285 | NIH | None | https://reporter.nih.gov/quic… | View |