Exercise Training Study for Patients With Cystic Fibrosis

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT00609050

Collaborator

National Institute of Nursing Research (NINR) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Behavioral: Self-Regulated Exercise with Telephone Reinforcement Behavioral: Standard Treatment Behavioral: Qualitative Approach	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Self-Regulated Exercise in CF: A Randomized Trial

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 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.
Active Comparator: 2 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.

Arm

Intervention/Treatment

Active Comparator: 1

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.

Active Comparator: 2

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.

Outcome Measures

Primary Outcome Measures

Cardiopulmonary Fitness: Peak VO2 [1 year]

Secondary Outcome Measures

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]