Effects of a Partially Supervised Conditioning Program in CF: an International Multi-centre, Randomized Controlled Trial

Status: Completed
Location: See all (28) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: No
View:

• Confirmed diagnosis of Cystic Fibrosis

• Age ≥12 years

• Forced expiratory volume in 1 second (FEV1) ≥ 35% predicted

• Access to the internet

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh
Other Locations
Austria
Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde,
Graz
Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene
Innsbruck
Canada
Montreal Children's Hospital, McGill University Health Centre - Glen Site
Monrtreal
France
Hôpital Renée Sabran, Service : Maladies respiratoires
Hyeres
Hôpital Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq
Lille Cedex
Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques
Lille Cedex
Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires
Montpellier Cedex 5
Hôpital Necker, Service : Pneumologie et allergologie pédiatriques
Paris
Hôpital Maison Blanche, Service : Maladies respiratoires
Reims
Germany
Pediatric Pulmonology and CF centre, Children´s Hospital, Ruhr University
Bochum
Klinik und Poliklinik für Kinderheilkunde - Universitäts-Mukoviszidose-Centrum
Dresden
Christiane Herzog CF-Zentrum, Goethe Universität
Frankfurt
CF Zentrum Hamburg-Altona, Kinderarztpraxis Runge, Sextro,Held
Hamburg
CF- Ambulanz, Kinderklinik, Pädiatrische Pneumologie, Allergologie und Neonatologie
Hannover
Zentrum für Kinder- und Jugendmedizin, Pädiatrische Pneumologie, Allergologie und Mukoviszidose
Mainz
Praxis für Lungen- und Bronchialheilkunde
Munich
Klinik für Kinder- und Jugendmedizin / Universitätsklinikum
Münster
Olgahospital, Klinikum Stuttgart
Stuttgart
Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen
Tübingen
Children´s Hospital of the University
Würzburg
Netherlands
University Medical Center, Child Development & Exercise Center, Wilhelmina Children's Hospital
Utrecht
Switzerland
Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie
Bern
QuartierBleu, Praxis für Pneumologie am Lindenhofspital
Bern
Kinderspital, Pneumologie
Zurich
UniversitätsSpital, Klinik für Pneumologie
Zurich
United Kingdom
Royal Hospital for Sick Children
Edinburgh
Time Frame
Start Date: July 1, 2014
Completion Date: October 15, 2018
Participants
Target number of participants: 155
Treatments
Experimental: Exercise Intervention
Add three hours of intense physical activities per week to baseline activities. Weekly exercise should include at least 30 minutes of strength building activities and at least two hours of aerobic activities. Exercise bouts lasting 20 min or longer will be counted with respect to total weekly training time.
No Intervention: Control
Keep activity level constant
Authors
John D Lowman, Steven M Rowe, Pradeep G Bhambhvani, Joachim Riethmüller, Bruno Ravoninjatovo, Anne Prevotat, Laurent Mely, Cordula Koerner-Rettberg, Rainald Fischer, Helge U Hebestreit, Stephan Illing, Jutta Hammermann, Raphaël Chiron, Caroline Thumerelle, Justyna Winiarska-Kiefer, Christina Smaczny, Krystyna Poplawska, Reta Fischer Biner, Sibylle Junge, Larry Lands, David M. Orenstein, Chantal Karila, Don Urquhart, Christian Benden, Jörg Große-Onnebrinck, Erik HJ Hulzebos, Anne Wegner, Helmut Ellemunter, Ernst Eber, Alexander Möller, Marcas M Bamman, Wolfgang Sextro, Nancy Alarie, Carmen Casaulta
Related Therapeutic Areas
Sponsors
Leads: Wuerzburg University Hospital

This content was sourced from clinicaltrials.gov

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