Effects of a Partially Supervised Conditioning Program in CF

NCT ID: NCT01744561

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-01
• Study Completion Date: 2018-10-15

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: 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.

Control

Keep activity level constant

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of Cystic Fibrosis
• Age ≥12 years
• Forced expiratory volume in 1 second (FEV1) ≥ 35% predicted
• Access to the internet

Exclusion Criteria

• 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuerzburg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Prof. Helge Hebestreit

Professor Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helge U Hebestreit, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hosptitals

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde,

Graz, , Austria

Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene

Innsbruck, , Austria

Montreal Children's Hospital, McGill University Health Centre - Glen Site

Monrtreal, Quebec, Canada

Hôpital Renée Sabran, Service : Maladies respiratoires

Hyères, , France

Hôpital Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq

Lille, , France

Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques

Lille, , France

Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires

Montpellier, , France

Hôpital Necker, Service : Pneumologie et allergologie pédiatriques

Paris, , France

Hôpital Maison Blanche, Service : Maladies respiratoires

Reims, , France

Olgahospital, Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Children´s Hospital of the University

Würzburg, Bavaria, Germany

Pediatric Pulmonology and CF centre, Children´s Hospital, Ruhr University

Bochum, , Germany

Klinik und Poliklinik für Kinderheilkunde - Universitäts-Mukoviszidose-Centrum

Dresden, , Germany

Christiane Herzog CF-Zentrum, Goethe Universität

Frankfurt, , Germany

CF Zentrum Hamburg-Altona, Kinderarztpraxis Runge, Sextro,Held

Hamburg, , Germany

CF- Ambulanz, Kinderklinik, Pädiatrische Pneumologie, Allergologie und Neonatologie

Hanover, , Germany

Zentrum für Kinder- und Jugendmedizin, Pädiatrische Pneumologie, Allergologie und Mukoviszidose

Mainz, , Germany

Praxis für Lungen- und Bronchialheilkunde

Munich, , Germany

Klinik für Kinder- und Jugendmedizin / Universitätsklinikum

Münster, , Germany

University Medical Center, Child Development & Exercise Center, Wilhelmina Children's Hospital

Utrecht, , Netherlands

QuartierBleu, Praxis für Pneumologie am Lindenhofspital

Bern, , Switzerland

Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie

Bern, , Switzerland

Kinderspital, Pneumologie

Zurich, , Switzerland

UniversitätsSpital, Klinik für Pneumologie

Zurich, , Switzerland

Royal Hospital for Sick Children

Edinburgh, Scottland, United Kingdom

Countries

United States; Austria; Canada; France; Germany; Netherlands; Switzerland; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 29422091 (View on PubMed)

Other Identifiers

ACT-CF-001

Identifier Type: -

Identifier Source: org_study_id