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Completed

NCT Number: NCT00609050

Exercise Training Study for Patients With Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Motor Activity Pancreatic Diseases Respiratory Tract Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antiono J & Janet Palumbo Cystic Fibrosis Center; Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-Regulated Exercise with Telephone Reinforcement

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Cardiopulmonary Fitness: Peak VO2

    Time frame: 1 year

Secondary outcomes

  1. Cardiopulmonary fitness: VO2150 and peak power output

    Time frame: 1 year

  2. Pulmonary function: FEV1 and sustained phonation time

    Time frame: 1 year

  3. Health-related quality of life: Quality of well-being scale and cystic fibrosis questionnaire

    Time frame: 1 Year

  4. Exercise experiences of children and parents: Interviews

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Self-Regulated Exercise in CF: A Randomized Trial

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 6, 2008
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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