Exercise Training Study for Patients With Cystic Fibrosis

Self-Regulated Exercise in CF: A Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: Self-Regulated Exercise with Telephone Reinforcement; Behavioral: Qualitative Approach; Behavioral: Standard Treatment

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Antiono J & Janet Palumbo Cystic Fibrosis Center; Children's Hospital of Pittsburgh of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiopulmonary Fitness: Peak VO2	1 year

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: David M Orenstein, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 31, 2008
• First Submitted That Met QC Criteria: February 1, 2008
• First Posted (Estimate): February 6, 2008

Study Record Updates

• Last Update Posted (Estimate): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: lung function; exercise; cystic fibrosis; health related quality of life; aerobic fitness; perceived exertion; self-regulated exercise
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: R01NR009285 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED