Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Exercise Training Study for Patients With Cystic Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Pittsburgh.
Recruitment status was  Recruiting
Information provided by:
University of Pittsburgh Identifier:
First received: January 31, 2008
Last updated: March 3, 2010
Last verified: March 2010

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 Intervention Phase
Cystic Fibrosis
Self Regulated Exercise
Behavioral: Self-Regulated Exercise with Telephone Reinforcement
Behavioral: Standard Treatment
Behavioral: Qualitative Approach
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self-Regulated Exercise in CF: A Randomized Trial

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Cardiopulmonary Fitness: Peak VO2 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiopulmonary fitness: VO2150 and peak power output [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Pulmonary function: FEV1 and sustained phonation time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Health-related quality of life: Quality of well-being scale and cystic fibrosis questionnaire [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Exercise experiences of children and parents: Interviews [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00609050

Contact: Linda W Higgins, PhD, RN 412-692-5872

United States, Pennsylvania
Antiono J & Janet Palumbo Cystic Fibrosis Center; Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: David M Orenstein, MD Children's Hospital of Pittsburgh
  More Information

No publications provided

Responsible Party: David M. Orenstein, MD, Children's Hospital of Pittsburgh Identifier: NCT00609050     History of Changes
Other Study ID Numbers: R01NR009285, R01NR009285
Study First Received: January 31, 2008
Last Updated: March 3, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
cystic fibrosis
perceived exertion
aerobic fitness
lung function
health related quality of life

Additional relevant MeSH terms:
Cystic Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases processed this record on February 27, 2015