Exercise Training Study for Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Self-Regulated Exercise in CF: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609050
• Other study ID #: R01NR009285
• Secondary ID: R01NR009285
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: February 18, 2016
• Start date: March 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
United States	Antiono J & Janet Palumbo Cystic Fibrosis Center; Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary Fitness: Peak VO2		1 year	No
Secondary	Cardiopulmonary fitness: VO2150 and peak power output		1 year	No
Secondary	Pulmonary function: FEV1 and sustained phonation time		1 year	No
Secondary	Health-related quality of life: Quality of well-being scale and cystic fibrosis questionnaire		1 Year	No
Secondary	Exercise experiences of children and parents: Interviews		1 Year	No