|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
National Institute of Nursing Research (NINR) University of Pittsburgh |
|---|---|
| Information provided by: | National Institute of Nursing Research (NINR) |
| ClinicalTrials.gov Identifier: | NCT00609050 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis Self Regulated Exercise |
Behavioral: Self-Regulated Exercise with Telephone Reinforcement Behavioral: Standard Treatment Behavioral: Qualitative Approach |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
| Official Title: | Self-Regulated Exercise in CF: A Randomized Trial |
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Self-Regulated Exercise with Telephone Reinforcement
|
Behavioral: Self-Regulated Exercise with Telephone Reinforcement
The self-regulated exercise with telephone reinforcement group will engage in a three-times-a-week (or more) at home exercise regimen for 6 months during which they may choose the mode of exercise. They will receive weekly telephone calls about exercise and airway clearance. After 6 months, they will be instructed to maintain their self-regulated exercise activity for the remaining 6 months of the study, but they will not receive telephone calls
Behavioral: Qualitative Approach
A qualitative naturalistic approach is nested within the primary experimental framework to explore the experiences of the children and parents, in both groups, with the exercise regimen.
|
|
2: Active Comparator
Attention Control
|
Behavioral: Standard Treatment
The attention control group will receive standard recommendations for exercise activity, during the first 6 months, as is common in our clinic. Also during the first 6 months, they will receive weekly telephone calls about airway clearance. For the final 6 months of the study, the attention control group will cross over to self-regulated exercise without telephone reinforcement.
Behavioral: Qualitative Approach
A qualitative naturalistic approach is nested within the primary experimental framework to explore the experiences of the children and parents, in both groups, with the exercise regimen.
|
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.
Eligibility| Ages Eligible for Study: | 10 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Linda W Higgins, PhD, RN | 412-692-5872 | linda.higgins@chp.edu |
| United States, Pennsylvania | |
| Antiono J & Janet Palumbo Cystic Fibrosis Center; Children's Hospital of Pittsburgh of UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | David M Orenstein, MD | Children's Hospital of Pittsburgh |
More Information
| Responsible Party: | Children's Hospital of Pittsburgh ( David M. Orenstein, MD ) |
| Study ID Numbers: | R01NR009285, R01NR009285 |
| Study First Received: | January 31, 2008 |
| Last Updated: | August 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00609050 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
|
cystic fibrosis exercise perceived exertion |
aerobic fitness lung function health related quality of life |
|
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis Lung Diseases |
Benzocaine Quality of Life Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
|
Pathologic Processes |
