Exercise Training Study for Patients With Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: Self-Regulated Exercise with Telephone Reinforcement; Behavioral: Standard Treatment; Behavioral: Qualitative Approach

• Registration Number: NCT00609050
• Lead Sponsor: University of Pittsburgh

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-01
• Study First Posted: 2008-02-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

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Exclusion Criteria

• Enrolled in another intervention study
• in structured aerobic activity for 30 continuous minutes 3 times per week
• sibling enrolled in study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Self-Regulated Exercise with Telephone Reinforcement	Self-Regulated Exercise with Telephone Reinforcement
2	Qualitative Approach	Attention Control
2	Standard Treatment	Attention Control
1	Qualitative Approach	Self-Regulated Exercise with Telephone Reinforcement

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary Fitness: Peak VO2	1 year

Secondary Outcome Measures

Name	Time	Method
Pulmonary function: FEV1 and sustained phonation time	1 year
Health-related quality of life: Quality of well-being scale and cystic fibrosis questionnaire	1 Year
Exercise experiences of children and parents: Interviews	1 Year
Cardiopulmonary fitness: VO2150 and peak power output	1 year

Trial Locations

Locations (1)

Antiono J & Janet Palumbo Cystic Fibrosis Center; Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States