Effects of a Partially Supervised Conditioning Program in CF
- Conditions
- Cystic Fibrosis
- Interventions
- Behavioral: Exercise Intervention
- Registration Number
- NCT01744561
- Lead Sponsor
- Wuerzburg University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
- Confirmed diagnosis of Cystic Fibrosis
- Age ≥12 years
- Forced expiratory volume in 1 second (FEV1) ≥ 35% predicted
- Access to the internet
- Participation in another clinical trial up to 4 weeks prior to the first baseline visit
- Pregnancy/Breastfeeding
- Inability to exercise
- More than 4 hours of reported strenuous physical activities per week currently or up to 3 months prior to baseline measurements and not already planned within the coming 6 months.
- Unstable condition precluding exercise (major hemoptysis or pneumothorax within the last 3 months, acute exacerbation and iv-antibiotics during the last 4 weeks, planned surgery, listed for lung transplantation, major musculoskeletal injuries such as fractures or sprains during the last 2 months, others according to the impression of the doctor)
- Cardiac arrhythmias with exercise
- Requiring additional oxygen with exercise
- Recent diagnosis of diabetes 3 months prior to screening or at screening
- Recent changes in medication 1 month or less prior to screening (systemic steroids, ibuprofen, inhaled antibiotics, mannitol, DNAse, hypertonic saline)
- At least one G551D mutation and not on ivacaftor (VX770) yet but planned start or planned stop of ivacaftor during the trial
- Colonization with Burkholderia cenocepacia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise Intervention 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.
- Primary Outcome Measures
Name Time Method Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls. baseline and 6 months
- Secondary Outcome Measures
Name Time Method Change in measured steps per day baseline to 6 months and baseline to 12 months Change in exercise steps per day baseline to 6 months and baseline to 12 months Days on additional oral / intravenous antibiotics baseline to 6 months and baseline to 12 months from questionnaire
Change in percent body fat baseline to 6 months and baseline to 12 months estimated from skinfold thickness
Change in depression, anxiety and stress scores baseline to 6 months and baseline to 12 months from Depression Anxiety Stress Scales
Serious adverse events baseline to 6 months and baseline to 12 months Change in reported physical activity baseline to 6 months and baseline to 12 months Change in forced vital capacity (FVC; % predicted) baseline to 6 months and baseline to 12 months Change in body mass index (kg/m2) baseline to 6 months and baseline to 12 months Change in muscle mass (kg) baseline to 6 months and baseline to 12 months estimated from skinfold thickness
Change in plasma glucose concentrations 1 and 2 hours after a standardized glucose load baseline to 9 months standardized oral glucose tolerance test only patients without diabetes mellitus
Change in peak oxygen uptake (%predicted) baseline to 6 months and baseline to 12 months Change in maximal aerobic power (%predicted) baseline to 6 months and baseline to 12 months Change in residual volume in percent of total lung capacity (RV/TLC; %) baseline to 6 months and baseline to 12 months Time to first exacerbation baseline to 6 months and baseline to 12 months Adverse events possibly or likely related to exercise baseline to 6 months and baseline to 12 months causality as judged by investigator
Change in forced expiratory volume in 1 second (FEV1; %predicted) baseline to 6 months and baseline to 12 months Number of upper respiratory tract infections baseline to 6 months and baseline to 12 months from diary
Severe adverse events baseline to 6 months and baseline to 12 months Change in Quality of Life scales baseline to 6 months and baseline to 12 months from the revised Cystic Fibrosis health-related quality of life Questionnaire (CFQ-R questionnaire)
Trial Locations
- Locations (28)
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Hôpital Maison Blanche, Service : Maladies respiratoires
🇫🇷Reims, France
Pediatric Pulmonology and CF centre, Children´s Hospital, Ruhr University
🇩🇪Bochum, Germany
CF- Ambulanz, Kinderklinik, Pädiatrische Pneumologie, Allergologie und Neonatologie
🇩🇪Hannover, Germany
CF Zentrum Hamburg-Altona, Kinderarztpraxis Runge, Sextro,Held
🇩🇪Hamburg, Germany
Praxis für Lungen- und Bronchialheilkunde
🇩🇪Munich, Germany
Kinderspital, Pneumologie
🇨🇭Zurich, Switzerland
Royal Hospital for Sick Children
🇬🇧Edinburgh, Scottland, United Kingdom
UniversitätsSpital, Klinik für Pneumologie
🇨🇭Zurich, Switzerland
Zentrum für Kinder- und Jugendmedizin, Pädiatrische Pneumologie, Allergologie und Mukoviszidose
🇩🇪Mainz, Germany
QuartierBleu, Praxis für Pneumologie am Lindenhofspital
🇨🇭Bern, Switzerland
Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde,
🇦🇹Graz, Austria
Christiane Herzog CF-Zentrum, Goethe Universität
🇩🇪Frankfurt, Germany
Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene
🇦🇹Innsbruck, Austria
Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires
🇫🇷Montpellier cedex 5, France
University Medical Center, Child Development & Exercise Center, Wilhelmina Children's Hospital
🇳🇱Utrecht, Netherlands
Montreal Children's Hospital, McGill University Health Centre - Glen Site
🇨🇦Monrtreal, Quebec, Canada
Hôpital Renée Sabran, Service : Maladies respiratoires
🇫🇷Hyeres, France
Hôpital Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq
🇫🇷Lille cedex, France
Klinik und Poliklinik für Kinderheilkunde - Universitäts-Mukoviszidose-Centrum
🇩🇪Dresden, Germany
Klinik für Kinder- und Jugendmedizin / Universitätsklinikum
🇩🇪Münster, Germany
Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques
🇫🇷Lille cedex, France
Olgahospital, Klinikum Stuttgart
🇩🇪Stuttgart, Baden-Württemberg, Germany
Children´s Hospital of the University
🇩🇪Würzburg, Bavaria, Germany
Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie
🇨🇭Bern, Switzerland
Hôpital Necker, Service : Pneumologie et allergologie pédiatriques
🇫🇷Paris, France
Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany