Clinical trial NCT01744561: Effects of a Partially Supervised Conditioning Program in CF
Official title: Effects of a Partially Supervised Conditioning Program in CF: an International Multi-centre, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Exercise
Motivation
Feedback
web-based diary
pedometer
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 155
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change in peak oxygen uptake (%predicted)
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in maximal aerobic power (%predicted)
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in measured steps per day
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in exercise steps per day
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in reported physical activity
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in forced expiratory volume in 1 second (FEV1; %predicted)
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in forced vital capacity (FVC; % predicted)
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in residual volume in percent of total lung capacity (RV/TLC; %)
timeFrame: baseline to 6 months and baseline to 12 months
measure: Time to first exacerbation
timeFrame: baseline to 6 months and baseline to 12 months
measure: Number of upper respiratory tract infections
timeFrame: baseline to 6 months and baseline to 12 months
measure: Days on additional oral / intravenous antibiotics
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in body mass index (kg/m2)
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in muscle mass (kg)
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in percent body fat
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in Quality of Life scales
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in depression, anxiety and stress scores
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in plasma glucose concentrations 1 and 2 hours after a standardized glucose load
timeFrame: baseline to 9 months
measure: Adverse events possibly or likely related to exercise
timeFrame: baseline to 6 months and baseline to 12 months
measure: Severe adverse events
timeFrame: baseline to 6 months and baseline to 12 months
measure: Serious adverse events
timeFrame: baseline to 6 months and baseline to 12 months
Other outcomes:
measure: Compliance with the exercise goal
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in lung clearance index
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in time spent in moderate-and-vigorous physical activity
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in bone mineral density and body composition
timeFrame: baseline to 6 months and baseline to 12 months
measure: Change in mucociliary clearance with exercise
timeFrame: baseline to 6 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Graz
country: Austria
facility: Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde,
city: Innsbruck
country: Austria
facility: Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene
city: Monrtreal
country: Canada
facility: Montreal Children's Hospital, McGill University Health Centre - Glen Site
state: Quebec
city: Hyeres
country: France
facility: Hôpital Renée Sabran, Service : Maladies respiratoires
city: Lille cedex
country: France
facility: Hôpital Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq
city: Lille cedex
country: France
facility: Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques
city: Montpellier cedex 5
country: France
facility: Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires
city: Paris
country: France
facility: Hôpital Necker, Service : Pneumologie et allergologie pédiatriques
city: Reims
country: France
facility: Hôpital Maison Blanche, Service : Maladies respiratoires
city: Stuttgart
country: Germany
facility: Olgahospital, Klinikum Stuttgart
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Würzburg
country: Germany
facility: Children´s Hospital of the University
state: Bavaria
city: Bochum
country: Germany
facility: Pediatric Pulmonology and CF centre, Children´s Hospital, Ruhr University
city: Dresden
country: Germany
facility: Klinik und Poliklinik für Kinderheilkunde - Universitäts-Mukoviszidose-Centrum
city: Frankfurt
country: Germany
facility: Christiane Herzog CF-Zentrum, Goethe Universität
city: Hamburg
country: Germany
facility: CF Zentrum Hamburg-Altona, Kinderarztpraxis Runge, Sextro,Held
city: Hannover
country: Germany
facility: CF- Ambulanz, Kinderklinik, Pädiatrische Pneumologie, Allergologie und Neonatologie
city: Mainz
country: Germany
facility: Zentrum für Kinder- und Jugendmedizin, Pädiatrische Pneumologie, Allergologie und Mukoviszidose
city: Munich
country: Germany
facility: Praxis für Lungen- und Bronchialheilkunde
city: Münster
country: Germany
facility: Klinik für Kinder- und Jugendmedizin / Universitätsklinikum
city: Utrecht
country: Netherlands
facility: University Medical Center, Child Development & Exercise Center, Wilhelmina Children's Hospital
city: Bern
country: Switzerland
facility: QuartierBleu, Praxis für Pneumologie am Lindenhofspital
city: Bern
country: Switzerland
facility: Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie
city: Zurich
country: Switzerland
facility: Kinderspital, Pneumologie
city: Zurich
country: Switzerland
facility: UniversitätsSpital, Klinik für Pneumologie
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scottland
Study officials:
affiliation: Wuerzburg University Hosptitals
name: Helge U Hebestreit, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.