TY  - JOUR
A1  - Hebestreit, Helge
A1  - Lands, Larry C.
A1  - Alarie, Nancy
A1  - Schaeff, Jonathan
A1  - Karila, Chantal
A1  - Orenstein, David M.
A1  - Urquhart, Don S.
A1  - Hulzebos, Erik H. J.
A1  - Stein, Lothar
A1  - Schindler, Christian
A1  - Kriemler, Susi
A1  - Radtke, Thomas
T1  - Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol
JF  - BMC Pulmonary Medicine
N2  - Background
Physical activity (PA) and exercise have become an accepted and valued component of cystic fibrosis (CF) care. Regular PA and exercise can positively impact pulmonary function, improve physical fitness, and enhance health-related quality of life (HRQoL). 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 forced expiratory volume in 1 s (FEV1) at 6 months in a large international group of CF patients. Secondary endpoints include patient reported HRQoL, as well as levels of anxiety and depression, and control of blood sugar.

Methods/design
It is planned that a total of 292 patients with CF 12 years and older with a FEV1 ≥ 35% predicted shall be randomised. Following baseline assessments (2 visits) patients are randomised 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 PA by at least 3 h per week on each clinic visit, the intervention group documents daily PA and inactivity time and receives a step counter to record their progress within a web-based diary. They also receive monthly phone calls from the study staff during the first 6 months of the study. After 6 months, they continue with the step counter and web-based programme for a further 6 months. The control group receives standard care and keeps their PA level constant during the study period. Thereafter, they receive the intervention as well.

Discussion
This is the first large, international multi-centre study to investigate the effects of a PA intervention in CF with motivational feedback on several health outcomes using modern technology. Should this relatively simple programme prove successful, it will be made available on a wider scale internationally.

Trial registration
ClinicalTrials.gov Identifier: NCT01744561; Registration date: December 6, 2012.
KW  - physical activity
KW  - exercise intervention
KW  - randomised controlled trial
KW  - partially-supervised
KW  - cystic fibrosis
Y1  - 2018
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-227960
VL  - 18
ER  -