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Randomized Controlled Trial
. 2018 Feb 8;18(1):31.
doi: 10.1186/s12890-018-0596-6.

Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol

Helge Hebestreit  1 , Larry C Lands  2 , Nancy Alarie  2 , Jonathan Schaeff  3 , Chantal Karila  4 , David M Orenstein  5 , Don S Urquhart  6 , Erik H J Hulzebos  7 , Lothar Stein  8 , Christian Schindler  9 , Susi Kriemler  10 , Thomas Radtke  10 ; ACTIVATE-CF Study Working Group
Affiliations
Randomized Controlled Trial

Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol

Helge Hebestreit et al. BMC Pulm Med. .

Abstract

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.

Keywords: Cystic fibrosis; Exercise intervention; Partially-supervised; Physical activity; Randomised controlled trial.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval was obtained from all respective ethical research committees from all participating institutions: Ethik-Kommission, Institut für Pharmakologie und Toxikologie, Würzburg, Wuerzburg, Germany; Ethik-Kommission der Medizinischen Fakultät, Ruhr Universität Bochum (RUB), Bochum, Germany; Ethik-Kommission an der Technischen Universität Dresden, Dresden, Germany; Ethik-Kommission, Medizinische Fakultät der Universität Duisburg-Essen, Essen, Germany; Ethik-Kommission der Ärztekammer Hamburg, Hamburg, Germany; Ethik-Kommission, Fachbereich Medizin Frankfurt, Goethe-Universität, Frankfurt; Germany; Ethik-Kommission, Medizinische Hochschule Hannover, Hannover, Germany; Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität, Münster, Muenster, Germany; Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität Tübingen, Tuebingen, Germany; Ländesärtzekammer Baden-Württemberg, Stuttgart, Germany; Ethik-Kommission, Landesärztekammer Rheinland-Pfalz, Mainz, Germany; Ethik-Kommission bei der Ludwig Maximilians Universität München, München, Germany; Ethik-Kommission der Medizinischen Universität Innsbruck, Innsbruck, Austria; Ethik-Kommission, Medizinische Universität Graz, Graz, Austria; Kantonale Ethik-Kommission, Kanton Zürich, Zurich, Switzerland; West of Scotland Research Ethics Service; Glasgow, UK; Comite de Protection des Personnes Ile De France III, Paris, France; Medisch Ethische Toetsingscommissie (METC) van het UMC Utrecht, Utrecht, Netherlands; Institutional Review Board for Human Use, The University of Alabama at Birmingham, Birmingham AL, US; Institutional Review Board, University of Pittsburgh, Pittsburgh, US; MUHC Research Ethics Board, Montreal, QC, Canada. The ethical commission of the Medical Faculty of the University of Wurzburg, Germany is the leading commission for this study (ref.no: 174/13). All study participants or their legal guardians, if participants are under age, will provide informed consent before any study-related procedures are performed. Participants under age will provide oral and written assent. The study protocol has been reviewed and accepted by the European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN) to run in ECFS-CTN sites.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1
Fig. 1
Study design and assessment time points
See this image and copyright information in PMC

References

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