Clinical trial NCT00609050: Exercise Training Study for Patients With Cystic Fibrosis
Official title: Self-Regulated Exercise in CF: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
exercise
perceived exertion
aerobic fitness
lung function
health related quality of life
self-regulated exercise
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2008-02-06
Enrollment: 38
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Cardiopulmonary Fitness: Peak VO2
timeFrame: 1 year
Secondary outcomes:
measure: Cardiopulmonary fitness: VO2150 and peak power output
timeFrame: 1 year
measure: Pulmonary function: FEV1 and sustained phonation time
timeFrame: 1 year
measure: Health-related quality of life: Quality of well-being scale and cystic fibrosis questionnaire
timeFrame: 1 Year
measure: Exercise experiences of children and parents: Interviews
timeFrame: 1 Year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Antiono J & Janet Palumbo Cystic Fibrosis Center; Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David M Orenstein, MD
role: PRINCIPAL_INVESTIGATOR
References: