Effects of a Partially Supervised Conditioning Program in CF

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.