Effects of a Partially Supervised Conditioning Program in CF

Cystic Fibrosis Clinical Trial

— ACTIVATE-CF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744561
• Other study ID #: ACT-CF-001
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: October 15, 2018

Study information

• Verified date: October 2018
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: October 15, 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Austria	Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde,	Graz
Austria	Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene	Innsbruck
Canada	Montreal Children's Hospital, McGill University Health Centre - Glen Site	Monrtreal	Quebec
France	Hôpital Renée Sabran, Service : Maladies respiratoires	Hyeres
France	Hôpital Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq	Lille cedex
France	Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques	Lille cedex
France	Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires	Montpellier cedex 5
France	Hôpital Necker, Service : Pneumologie et allergologie pédiatriques	Paris
France	Hôpital Maison Blanche, Service : Maladies respiratoires	Reims
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	Hannover
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	Olgahospital, Klinikum Stuttgart	Stuttgart	Baden-Württemberg
Germany	Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen	Tübingen	Baden-Württemberg
Germany	Children´s Hospital of the University	Würzburg	Bavaria
Netherlands	University Medical Center, Child Development & Exercise Center, Wilhelmina Children's Hospital	Utrecht
Switzerland	Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie	Bern
Switzerland	QuartierBleu, Praxis für Pneumologie am Lindenhofspital	Bern
Switzerland	Kinderspital, Pneumologie	Zurich
Switzerland	UniversitätsSpital, Klinik für Pneumologie	Zurich
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scottland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Countries where clinical trial is conducted

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

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance with the exercise goal	based on questionnaire and diary	baseline to 6 months and baseline to 12 months
Other	Change in lung clearance index	based on nitrogen multiple breath washout, in selected centres only	baseline to 6 months and baseline to 12 months
Other	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
Other	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
Other	Change in mucociliary clearance with exercise	based on nuclear medicine scans, US centres only	baseline to 6 months
Primary	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	Change in peak oxygen uptake (%predicted)		baseline to 6 months and baseline to 12 months
Secondary	Change in maximal aerobic power (%predicted)		baseline to 6 months and baseline to 12 months
Secondary	Change in measured steps per day		baseline to 6 months and baseline to 12 months
Secondary	Change in exercise steps per day		baseline to 6 months and baseline to 12 months
Secondary	Change in reported physical activity		baseline to 6 months and baseline to 12 months
Secondary	Change in forced expiratory volume in 1 second (FEV1; %predicted)		baseline to 6 months and baseline to 12 months
Secondary	Change in forced vital capacity (FVC; % predicted)		baseline to 6 months and baseline to 12 months
Secondary	Change in residual volume in percent of total lung capacity (RV/TLC; %)		baseline to 6 months and baseline to 12 months
Secondary	Time to first exacerbation		baseline to 6 months and baseline to 12 months
Secondary	Number of upper respiratory tract infections	from diary	baseline to 6 months and baseline to 12 months
Secondary	Days on additional oral / intravenous antibiotics	from questionnaire	baseline to 6 months and baseline to 12 months
Secondary	Change in body mass index (kg/m2)		baseline to 6 months and baseline to 12 months
Secondary	Change in muscle mass (kg)	estimated from skinfold thickness	baseline to 6 months and baseline to 12 months
Secondary	Change in percent body fat	estimated from skinfold thickness	baseline to 6 months and baseline to 12 months
Secondary	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
Secondary	Change in depression, anxiety and stress scores	from Depression Anxiety Stress Scales	baseline to 6 months and baseline to 12 months
Secondary	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
Secondary	Adverse events possibly or likely related to exercise	causality as judged by investigator	baseline to 6 months and baseline to 12 months
Secondary	Severe adverse events		baseline to 6 months and baseline to 12 months
Secondary	Serious adverse events		baseline to 6 months and baseline to 12 months