Exercise Training Study for Patients With Cystic Fibrosis

University of Pittsburgh

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Behavioral: Self-Regulated Exercise with Telephone Reinforcement; Behavioral: Qualitative Approach; Behavioral: Standard Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00609050

R01NR009285 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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38 participants in 2 patient groups

1

Active Comparator group

Description:

Self-Regulated Exercise with Telephone Reinforcement

Treatment:

Behavioral: Self-Regulated Exercise with Telephone Reinforcement

Behavioral: Qualitative Approach

2

Active Comparator group

Description:

Attention Control

Treatment:

Behavioral: Standard Treatment

Behavioral: Qualitative Approach