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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention | Experimental | 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. |
|
| Control | No Intervention | Keep activity level constant |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with the exercise goal | based on questionnaire and diary | baseline to 6 months and baseline to 12 months |
| Change in lung clearance index | based on nitrogen multiple breath washout, in selected centres only |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helge U Hebestreit, Dr. med. | Wuerzburg University Hosptitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-1212 | United States | ||
| Children's Hospital of Pittsburgh of UPMC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29422091 | Background | Hebestreit H, Lands LC, Alarie N, Schaeff J, Karila C, Orenstein DM, Urquhart DS, Hulzebos EHJ, Stein L, Schindler C, Kriemler S, Radtke T; ACTIVATE-CF Study Working Group. Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol. BMC Pulm Med. 2018 Feb 8;18(1):31. doi: 10.1186/s12890-018-0596-6. |
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|
| 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 |
| Change in reported physical activity | baseline to 6 months and baseline to 12 months |
| Change in forced expiratory volume in 1 second (FEV1; %predicted) | 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 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 |
| Number of upper respiratory tract infections | from diary | baseline to 6 months and baseline to 12 months |
| Days on additional oral / intravenous antibiotics | from questionnaire | 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) | estimated from skinfold thickness | baseline to 6 months and baseline to 12 months |
| Change in percent body fat | estimated from skinfold thickness | baseline to 6 months and baseline to 12 months |
| Change in Quality of Life scales | from the revised Cystic Fibrosis health-related quality of life Questionnaire (CFQ-R questionnaire) | baseline to 6 months and baseline to 12 months |
| Change in depression, anxiety and stress scores | from Depression Anxiety Stress Scales | baseline to 6 months and baseline to 12 months |
| Change in plasma glucose concentrations 1 and 2 hours after a standardized glucose load | standardized oral glucose tolerance test only patients without diabetes mellitus | baseline to 9 months |
| Adverse events possibly or likely related to exercise | causality as judged by investigator | baseline to 6 months and baseline to 12 months |
| Severe adverse events | baseline to 6 months and baseline to 12 months |
| Serious adverse events | baseline to 6 months and baseline to 12 months |
| baseline to 6 months and baseline to 12 months |
| Change in time spent in moderate-and-vigorous physical activity | based on accelerometry, in selected centres only | baseline to 6 months and baseline to 12 months |
| Change in bone mineral density and body composition | based on dual energy x-ray absorptiometry, in selected centres only | baseline to 6 months and baseline to 12 months |
| Change in mucociliary clearance with exercise | based on nuclear medicine scans, US centres only | baseline to 6 months |
| Pittsburgh |
| Pennsylvania |
| 15224 |
| United States |
| Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde, | Graz | 8036 | Austria |
| Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene | Innsbruck | 6020 | Austria |
| Montreal Children's Hospital, McGill University Health Centre - Glen Site | Monrtreal | Quebec | H4A 3J1 | Canada |
| Hôpital Renée Sabran, Service : Maladies respiratoires | Hyères | 83406 | France |
| Hôpital Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq | Lille | 59037 | France |
| Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques | Lille | 59037 | France |
| Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires | Montpellier | 34295 | France |
| Hôpital Necker, Service : Pneumologie et allergologie pédiatriques | Paris | 75015 | France |
| Hôpital Maison Blanche, Service : Maladies respiratoires | Reims | 51092 | France |
| Olgahospital, Klinikum Stuttgart | Stuttgart | Baden-Wurttemberg | 70174 | Germany |
| Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Children´s Hospital of the University | Würzburg | Bavaria | 97080 | Germany |
| Pediatric Pulmonology and CF centre, Children´s Hospital, Ruhr University | Bochum | 44791 | Germany |
| Klinik und Poliklinik für Kinderheilkunde - Universitäts-Mukoviszidose-Centrum | Dresden | 01307 | Germany |
| Christiane Herzog CF-Zentrum, Goethe Universität | Frankfurt | 60323 | Germany |
| CF Zentrum Hamburg-Altona, Kinderarztpraxis Runge, Sextro,Held | Hamburg | 22763 | Germany |
| CF- Ambulanz, Kinderklinik, Pädiatrische Pneumologie, Allergologie und Neonatologie | Hanover | 30625 | Germany |
| Zentrum für Kinder- und Jugendmedizin, Pädiatrische Pneumologie, Allergologie und Mukoviszidose | Mainz | 55101 | Germany |
| Praxis für Lungen- und Bronchialheilkunde | Munich | 81241 | Germany |
| Klinik für Kinder- und Jugendmedizin / Universitätsklinikum | Münster | 48149 | Germany |
| University Medical Center, Child Development & Exercise Center, Wilhelmina Children's Hospital | Utrecht | Netherlands |
| QuartierBleu, Praxis für Pneumologie am Lindenhofspital | Bern | 3001 | Switzerland |
| Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie | Bern | Switzerland |
| Kinderspital, Pneumologie | Zurich | 8032 | Switzerland |
| UniversitätsSpital, Klinik für Pneumologie | Zurich | 8091 | Switzerland |
| Royal Hospital for Sick Children | Edinburgh | Scottland | EH9 1LF | United Kingdom |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001519 | Behavior |
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