Exercise Training Study for Patients With Cystic Fibrosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Self-Regulated Exercise in CF: A Randomized Trial

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Self-Regulated Exercise with Telephone Reinforcement
* Behavioral: Standard Treatment
* Behavioral: Qualitative Approach


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Self-Regulated Exercise with Telephone Reinforcement | Behavioral: Self-Regulated Exercise with Telephone Reinforcement<br>* 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<br>Behavioral: Qualitative Approach<br>* 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.<br>|
| Active Comparator: 2<br>Attention Control | Behavioral: Standard Treatment<br>* 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.<br>Behavioral: Qualitative Approach<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary Fitness: Peak VO2 |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary fitness: VO2150 and peak power output |  | 1 year | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystic fibrosis, exercise, perceived exertion, aerobic fitness, lung function, health related quality of life, self-regulated exercise