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Effects of a 6-months partially supervised conditioning program in cystic fibrosis: an international multi-centre, randomized controlled trial (ACTIVATE-CF)

English title Effects of a 6-months partially supervised conditioning program in cystic fibrosis: an international multi-centre, randomized controlled trial (ACTIVATE-CF)
Applicant Kriemler Susi
Number 144175
Funding scheme Project funding (Div. I-III)
Research institution Institut für Sozial- und Präventivmedizin Universität Zürich
Institution of higher education University of Zurich - ZH
Main discipline Sport Medicine
Start/End 01.03.2014 - 28.02.2017
Approved amount 286'216.00
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All Disciplines (2)

Discipline
Sport Medicine
Internal Medicine

Keywords (6)

mutation; exercise; osteoporosis; cystic fibrosis; physical activity; lung function

Lay Summary (German)

Lead
Cystische Fibrose (CF) ist eine der häufigsten Erbkrankheiten, die mit einer erhöhten Sterblichkeit im jungen Erwachsenenalter einhergeht, meist durch eine durch chronische Infekte zerstörte Lunge. Regelmässiges körperliches Training kann neben einem verminderten Rückgang der Lungenfunktion, die Lebensqualität und körperliche Leistungsfähigkeit verbessern und gar die Sterblichkeit herauszögern.
Lay summary

Titel des Forschungsprojekts

Auswirkung eines teilweise überwachten Trainingsprogramms bei Patienten mit Cystischer Fibrose (CF): eine internationale, multizentrische randomisierte, kontrollierte Studie

 

Lead

Cystische Fibrose (CF) ist eine der häufigsten Erbkrankheiten, die mit einer erhöhten Sterblichkeit im jungen Erwachsenenalter einhergeht, meist durch eine durch chronische Infekte zerstörte Lunge. Regelmässiges körperliches Training kann neben einem verminderten Rückgang der Lungenfunktion, die Lebensqualität und körperliche Leistungsfähigkeit verbessern und gar die Sterblichkeit herauszögern.

 

Inhalt und Ziele des Forschungsprojekts

Körperliche Trainingsprogramme sind zu einem wichtigen Standpunkt der Therapie von chronischen Erkrankungen wie CF geworden, wobei das ideale Programm zur idealen Beeinflussung des Krankheitsverlaufs und der bestmöglichen Durchführbarkeit durch die Patienten noch unklar ist. Wir möchten deshalb untersuchen, ob ein teilweise überwachtes Trainingsprogramm (+3 Std/Woche über 12 Monate) auf der Basis von modernen, attraktiven Motivationsmethoden durch persönliche feedbacks mittels Schrittzählern und per Internet den Krankheitsverlauf von CF Patienten optimal zu beeinflussen vermögen. Die Studie wird wegen der seltenen Erkrankung und um die Generalisierbarkeit und schlussendliche Umsetzung bei Erfolg zu gewähren, weltweit in 7-9 Ländern (CH, D, AU, F, CAN, UK, ev. USA und NL) durchgeführt an 300 12-40-jährigen CF Patienten mit genügendem Gesundheitszustand für ein Training einschliessen.

 

Wissenschaftlicher und gesellschaftlicher Kontext des Forschungsprojekts

Das Projekt beschäftigt sich mit klinisch angewandter Forschung. Körperliches Training birgt ein minimales Risiko für die CF Patienten und ist eine kostengünstige Therapiemodalität, die geprüft werden sollte hinsichtlich des Krankheitsverlaufs diesen Patienten. Im Falle positiver Gesundheitseffekte wird das Programm interessierten CF Zentren kostenlos zur Verfügung stehen in verschiedenen Sprachen. 

Direct link to Lay Summary Last update: 17.02.2014

Responsible applicant and co-applicants

Employees

Publications

Publication
Physical exercise training for cystic fibrosis
Radtke T Nolan SJ Hebestreit H Kriemler S. (2016), Physical exercise training for cystic fibrosis, in Paediatric Respiratory Reviews, Jun(19), 42-45.
Exercise for all cystic fibrosis patients: is the evidence strengthening?
Hebestreit H Kriemler S Radtke T (2015), Exercise for all cystic fibrosis patients: is the evidence strengthening?, in Curr Opin Pulm Med, (21), 591-595.
Physical exercise training for cystic fibrosis
Radtke T Nolan SJ Hebestreit H Kriemler S (2015), Physical exercise training for cystic fibrosis, in Cochrane Database of Systematic Reviews, 1.

Collaboration

Group / person Country
Types of collaboration
Prof. Dr. C. Benden, UZH Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
Prof. Dr. Larry C. Lands Canada (North America)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
Prof. Dr. David Orenstein United States of America (North America)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
Dr. Chantal Karila France (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
Prof. Dr. H. Dressel, EBPI Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
Prof. Dr. M. Puhan, EBPI Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Swiss national CF centers Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
Dr. Don Urquhart Great Britain and Northern Ireland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
Prof. Dr. Helge Hebestreit Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Exchange of personnel

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
Annual meeting of the European Cystic Fibrosis Society Talk given at a conference Activitate CF 08.06.2016 Basel, Switzerland Kriemler Susi; Radtke Thomas;
General Assembly Talk given at a conference Exercise in CF 09.04.2016 Bern, Switzerland Radtke Thomas;
Annual meeting of the European Cystic Fibrosis Society Talk given at a conference Exercise interventions in CF 10.06.2015 Brussels, Belgium Kriemler Susi; Radtke Thomas;
National scientific CF meeting (Groupe Romandie) Talk given at a conference CF and exercise 02.10.2014 Geneva, Switzerland Kriemler Susi;
Annual Assembliy of the European Society for Cystic Fibrosis Talk given at a conference Kickoff meeting Activate-CF partners 11.06.2014 Goteborg, Sweden Kriemler Susi; Radtke Thomas;


Knowledge transfer events

Active participation

Title Type of contribution Date Place Persons involved
Körperliche Aktivität bei CF Talk 09.04.2016 Bern, Switzerland Radtke Thomas;
Wissenswertes über Sport bei CF Talk 20.06.2015 Bern, Switzerland Kriemler Susi;


Self-organised

Title Date Place
Workshop for CF patients 01.12.2016 Gran Canaria, Spain
Workshop for CF patients 28.11.2015 Gran Canaria, Spain
Workshop for CF patients 27.11.2014 Gran Canaria, Spain

Communication with the public

Communication Title Media Place Year
Talks/events/exhibitions Körperliches Training bei Cystischer Fibrose German-speaking Switzerland 2016

Associated projects

Number Title Start Funding scheme
124976 3-year follow up of a multicomponent physical activity intervention (KISS) in primary school 01.04.2009 Project funding (special)

Abstract

Introduction: Regular physical activity and exercise have become an important part in therapy of cystic fibrosis (CF) as it is associated with higher exercise capacity, a stabilisation or even an improvement in lung function and a higher quality of life. Moreover, exercise capacity is one of the best predictors of mortality in CF and if improved by exercise may lead to a prolonged life. Well designed small randomized controlled conditioning studies found an increase in forced vital capacity (FVC), but not in FEV1. Furthermore, important aspects of exercise effects on glucose control, osteoporosis, depression, clinical status or the moderating effect of the existing gene mutation have not been evaluated.Objectives: The primary objective of this study is to assess the effects of a partially supervised individualized exercise program supported by motivational feedback on FEV1. Secondary endpoints include physical activity, exercise performance, anthropometry, osteoporosis, glycemic control, quality of life, depression, clinical status including exacerbations, antibiotics use, adverse effects of exercise, and moderating effects by the CF mutation. Design of the study: For this international multicenter randomized controlled trial a total of 300 patients with CF 12 years and older with a FEV1 >35% predicted will be recruited from centres in Switzerland, Germany, Austria, Australia, Canada, France, United Kingdom, and United States. Following the baseline assessments (2 visits) patients will be randomized into an intervention and a control group 1:1 on the basis of a center-based computer generated random number table by a person not involved in the study. Thereafter, they will be seen every 3 months for 4 follow-up assessments over one year. The intervention group will be asked to increase physical activity by at least three hours of intense physical activity weekly, including at least 30 min of strength building exercises and two hours of aerobic exercises per week. In addition, they are told to reduce screen time by 25%. Regular feedback will be given via a step counter (pedometer), an individual web-based activity diary, and by the centre staff. The control group participants will keep their activity level constant. After 6 months, the control group will receive the full intervention while the intervention group will continue with the intervention at a lower level of supervision.CF-relevance: Based on previous work of our group and others it is expected that participants will increase their physical activity, their physical fitness, their quality of life and likely their pulmonary function. There is very little risk associated with the drug “exercise”, especially in patients with CF. The evaluation of the program will not only be able to show whether a partially supervised exercise intervention can improve lung health in CF, but will also allow to assess for the first time the effects of regular exercise on bone health, depression scores and glycemic control in patients with CF and whether exercise effects are moderated by the CF mutation. If the program shall prove effective, a complete package will become available to interested CF centres in English, French and German to promote exercise in almost all patients. The program will allow centres without previous experience in exercise counselling to improve the care for their patients.
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