Effects of a Partially Supervised Conditioning Program in CF

Study Overview
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Brief Summary
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Physical activity and exercise have become an accepted and valued component of Cystic Fibrosis care. Regular physical activity and exercise can slow the rate of decline of pulmonary function, improve physical fitness, and enhance quality of life. However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labor intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a 12-months partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 second (FEV1) in a large international group of cystic fibrosis patients. Secondary endpoints include patient reported quality of life, as well as levels of anxiety and depression, and control of blood sugar. A total of 292 patients with cystic fibrosis 12 years and older with a FEV1 ≥35% predicted will be recruited. Following baseline assessments (2 visits) patients will be randomized into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counseling to increase vigorous physical activity by at least 3 hours per week on each clinic visit, the intervention group will document daily exercise and inactivity time and will receive a step counter and they will record their progress with a web-based program. They will also receive monthly phone calls from the study staff. After 6 months, they will continue with the step counter and web-based program for a further 6 months. The control group will receive access to this intervention after 12 months of standardized care. Should this relatively simple program prove successful, this will be made available on a wider scale internationally.

Official Title
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Effects of a Partially Supervised Conditioning Program in CF: an International Multi-centre, Randomized Controlled Trial

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of Cystic Fibrosis Age ≥12 years Forced expiratory volume in 1 second (FEV1) ≥ 35% predicted Access to the internet Exclusion Criteria: Participation in another clinical trial up to 4 weeks prior to the first baseline visit Pregnancy/Breastfeeding Inability to exercise More than 4 hours of reported strenuous physical activities per week currently or up to 3 months prior to baseline measurements and not already planned within the coming 6 months. Unstable condition precluding exercise (major hemoptysis or pneumothorax within the last 3 months, acute exacerbation and iv-antibiotics during the last 4 weeks, planned surgery, listed for lung transplantation, major musculoskeletal injuries such as fractures or sprains during the last 2 months, others according to the impression of the doctor) Cardiac arrhythmias with exercise Requiring additional oxygen with exercise Recent diagnosis of diabetes 3 months prior to screening or at screening Recent changes in medication 1 month or less prior to screening (systemic steroids, ibuprofen, inhaled antibiotics, mannitol, DNAse, hypertonic saline) At least one G551D mutation and not on ivacaftor (VX770) yet but planned start or planned stop of ivacaftor during the trial Colonization with Burkholderia cenocepacia

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention<br>Add three hours of intense physical activities per week to baseline activities. Weekly exercise should include at least 30 minutes of strength building activities and at least two hours of aerobic activities. Exercise bouts lasting 20 min or longer will be counted with respect to total weekly training time. | Behavioral: Exercise Intervention<br>* Add three hours of intense physical activities per week to baseline activities. Weekly exercise should include at least 30 minutes of strength building activities and at least two hours of aerobic activities. Exercise bouts lasting 20 min or longer will be counted with respect to total weekly training time.<br>|
| No Intervention: Control<br>Keep activity level constant | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls. |  | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak oxygen uptake (%predicted) |  | baseline to 6 months and baseline to 12 months | 
| Change in maximal aerobic power (%predicted) |  | baseline to 6 months and baseline to 12 months | 
| Change in measured steps per day |  | baseline to 6 months and baseline to 12 months | 
| Change in exercise steps per day |  | baseline to 6 months and baseline to 12 months | 
| Change in reported physical activity |  | baseline to 6 months and baseline to 12 months | 
| Change in forced expiratory volume in 1 second (FEV1; %predicted) |  | baseline to 6 months and baseline to 12 months | 
| Change in forced vital capacity (FVC; % predicted) |  | baseline to 6 months and baseline to 12 months | 
| Change in residual volume in percent of total lung capacity (RV/TLC; %) |  | baseline to 6 months and baseline to 12 months | 
| Time to first exacerbation |  | baseline to 6 months and baseline to 12 months | 
| Number of upper respiratory tract infections | from diary | baseline to 6 months and baseline to 12 months | 
| Days on additional oral / intravenous antibiotics | from questionnaire | baseline to 6 months and baseline to 12 months | 
| Change in body mass index (kg/m2) |  | baseline to 6 months and baseline to 12 months | 
| Change in muscle mass (kg) | estimated from skinfold thickness | baseline to 6 months and baseline to 12 months | 
| Change in percent body fat | estimated from skinfold thickness | baseline to 6 months and baseline to 12 months | 
| Change in Quality of Life scales | from the revised Cystic Fibrosis health-related quality of life Questionnaire (CFQ-R questionnaire) | baseline to 6 months and baseline to 12 months | 
| Change in depression, anxiety and stress scores | from Depression Anxiety Stress Scales | baseline to 6 months and baseline to 12 months | 
| Change in plasma glucose concentrations 1 and 2 hours after a standardized glucose load | standardized oral glucose tolerance test only patients without diabetes mellitus | baseline to 9 months | 
| Adverse events possibly or likely related to exercise | causality as judged by investigator | baseline to 6 months and baseline to 12 months | 
| Severe adverse events |  | baseline to 6 months and baseline to 12 months | 
| Serious adverse events |  | baseline to 6 months and baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Motivation, Feedback, web-based diary, pedometer