Exercise Training Study for Patients With Cystic Fibrosis

NCT00609050 | Completed DMC

• 1 other identifier: R01NR009285
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; exercise; perceived exertion; aerobic fitness; lung function; health related quality of life; self-regulated exercise

Outcome Measures

Primary Outcomes (1)

• Cardiopulmonary Fitness: Peak VO2

  1 year

Secondary Outcomes (4)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Self-Regulated Exercise with Telephone Reinforcement

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

2

ACTIVE COMPARATOR

Attention Control

Behavioral: Standard Treatment; Behavioral: Qualitative Approach

Interventions

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

1

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.

2

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.

1; 2

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Enrolled in another intervention study
• in structured aerobic activity for 30 continuous minutes 3 times per week
• sibling enrolled in study.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

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

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Officials

• David M Orenstein, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 6, 2008
• Study Start: March 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

US (1)