ACTIVATE-CF
Research type
Research Study
Full title
Effects of a partially supervised conditioning program in Cystic Fibrosis: an international multi-centre, randomized controlled trial
IRAS ID
156423
Contact name
Don Urquhart
Contact email
Sponsor organisation
Würzburg University Hospital
Clinicaltrials.gov Identifier
Research summary
Exercise is an accepted and valued component of Cystic Fibrosis (CF) 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 labour 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 partially supervised exercise intervention along with regular motivation on FEV1 at 6 months in CF 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 CF aged 12 years and older will be studied. 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 counselling 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 during the first 6 months of the study. After 6 months, they will continue with the step counter and web-based program for a further 6 months. The control group will receive standard care and keep their activity level constant during the study period. Thereafter, they will receive this intervention. Should this relatively simple program prove successful, this will be made available on a wider scale internationally.
REC name
West of Scotland REC 3
REC reference
14/WS/1102
Date of REC Opinion
10 Dec 2014
REC opinion
Further Information Favourable Opinion