Exercise Training Study for Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

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.
    

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.
    

Intervention name(s): Self-Regulated Exercise with Telephone Reinforcement; Standard Treatment; Qualitative Approach
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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; 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cystic fibrosis; exercise; perceived exertion; aerobic fitness; lung function; health related quality of life; self-regulated exercise