NCT01744561: ACTIVATE-CF

Effects of a Partially Supervised Conditioning Program in CF

Completed NA Last updated 22 October 2018

What this trial tests

NA trial testing Exercise Intervention in Cystic Fibrosis in 155 participants. Completed in 15 October 2018.

Timeline

1 July 2014

Primary endpoint
15 October 2018

15 October 2018

Quick facts

Lead sponsor	Wuerzburg University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	155
Start date	1 July 2014
Primary completion	15 October 2018
Estimated completion	15 October 2018
Sites	28 locations across France, Netherlands, Austria, United Kingdom, Germany, Canada, Switzerland, United States

Drugs / interventions tested

• Exercise Intervention

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Wuerzburg University Hospital

Who can join

12 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Physical exercise training for cystic fibrosis.
   Radtke T, Nevitt SJ, Hebestreit H, Kriemler S. · · 2017 · cited 81× · PMID 29090734 · DOI 10.1002/14651858.cd002768.pub4
2. Physical activity and exercise training in cystic fibrosis.
   Radtke T, Smith S, Nevitt SJ, Hebestreit H, et al · · 2022 · cited 31× · PMID 35943025 · DOI 10.1002/14651858.cd002768.pub5
3. Current and future treatment options for cystic fibrosis lung disease: latest evidence and clinical implications.
   Edmondson C, Davies JC. · · 2016 · cited 29× · PMID 27347364 · DOI 10.1177/2040622316641352
4. Effects of a Partially Supervised Conditioning Program in Cystic Fibrosis: An International Multicenter, Randomized Controlled Trial (ACTIVATE-CF).
   Hebestreit H, Kriemler S, Schindler C, Stein L, et al · · 2022 · cited 21× · PMID 34735776 · DOI 10.1164/rccm.202106-1419oc
5. Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol.
   Hebestreit H, Lands LC, Alarie N, Schaeff J, et al · · 2018 · cited 17× · PMID 29422091 · DOI 10.1186/s12890-018-0596-6
6. The 2025 European Cystic Fibrosis Society position statement on physical activity assessment in cystic fibrosis.
   Williams CA, Button B, Dwyer TJ, Hatziagorou E, et al · · 2025 · PMID 40633976 · DOI 10.1183/16000617.0279-2024