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Effects of a Partially Supervised Conditioning Program in CF (ACTIVATE-CF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Wuerzburg University Hospital
Sponsor:
Information provided by (Responsible Party):
Prof. Helge Hebestreit, Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT01744561
First received: December 5, 2012
Last updated: November 10, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Behavioral: Exercise Intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of a Partially Supervised Conditioning Program in CF: an International Multi-centre, Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in peak oxygen uptake (%predicted) [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in maximal aerobic power (%predicted) [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in measured steps per day [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in exercise steps per day [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in reported physical activity [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in forced expiratory volume in 1 second (FEV1; %predicted) [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in forced vital capacity (FVC; % predicted) [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in residual volume in percent of total lung capacity (RV/TLC; %) [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
  • Time to first exacerbation [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
  • Number of upper respiratory tract infections [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
    from diary

  • Days on additional oral / intravenous antibiotics [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
    from questionnaire

  • Change in body mass index (kg/m2) [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in muscle mass (kg) [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
    estimated from skinfold thickness

  • Change in percent body fat [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
    estimated from skinfold thickness

  • Change in Quality of Life scales [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
    from the revised Cystic Fibrosis health-related quality of life Questionnaire (CFQ-R questionnaire)

  • Change in depression, anxiety and stress scores [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
    from Depression Anxiety Stress Scales

  • Change in plasma glucose concentrations 1 and 2 hours after a standardized glucose load [ Time Frame: baseline to 9 months ] [ Designated as safety issue: No ]
    standardized oral glucose tolerance test only patients without diabetes mellitus

  • Adverse events possibly or likely related to exercise [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: Yes ]
    causality as judged by investigator

  • Severe adverse events [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Compliance with the exercise goal [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
    based on questionnaire and diary


Estimated Enrollment: 292
Study Start Date: July 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
No Intervention: Control
Keep activity level constant

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744561

Contacts
Contact: Helge U Hebestreit, Prof. Dr. +49 931 201 27728 hebestreit@uni-wuerzburg.de

Locations
Austria
Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde, Not yet recruiting
Graz, Austria, 8036
Contact: Ernst Eber, Prof. Dr.       ernst.eber@medunigraz.at   
Principal Investigator: Ernst Eber, Prof. Dr.         
Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene Recruiting
Innsbruck, Austria, 6020
Contact: Helmut Ellemunter, Prof. Dr.    +43 512 504 24902    helmut.ellemunter@i-med.ac.at   
Contact: Bianca Rabanser, BSc       Bianca.Rabanser@student.uibk.ac.at   
Principal Investigator: Helmut Ellemunter, Prof. Dr.         
France
CHU de Grenoble, Service : Pneumologie Not yet recruiting
Grenoble cedex, France, 38043
Contact: Sébastien Quetant, Dr.    +33 4 76 76 72 02    squetant@chu-grenoble.fr   
Principal Investigator: Sébastien Quetant, Dr.         
Hôpital Renée Sabran, Service : Maladies respiratoires Not yet recruiting
Hyeres, France, 83406
Contact: Laurent Mely, Dr.    +33 4 94 38 17 40    Laurent.mely@chu-lyon.fr   
Principal Investigator: Laurent Mely, Dr.         
Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques Not yet recruiting
Lille cedex, France, 59037
Contact: Caroline Thumerelle, Dr.    +33 3 20 44 50 72    Caroline.thumerelle@chru-lille.fr   
Principal Investigator: Caroline Thumerelle, Dr.         
Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires Not yet recruiting
Montpellier cedex 5, France, 34295
Contact: Raphaël Chiron, Dr.    +33 4 67 33 60 89    r-chiron@chu-montpellier.fr   
Principal Investigator: Raphaël Chiron, Dr.         
Hôpitaux pédiatriques de Nice CHU-LENVAL, Service : Explorations fonctionnelles Not yet recruiting
Nice, France, 06200
Contact: Marie Giànnantonio, Dr.    +33 6 50 23 31 22    giannantonio.m@pediatrie-chulenval-nice.fr   
Principal Investigator: Marie Giànnantonio, Dr.         
Hôpital Necker, Service : Pneumologie et allergologie pédiatriques Recruiting
Paris, France, 75015
Contact: Chantal Karila, Dr.    +33 1 49 09 58 30    chantal.karila@nck.aphp.fr   
Contact: Clotilde Simon       clotilde.simon@cch.aphp.fr   
Principal Investigator: Chantal Karila, Dr.         
Hôpital Maison Blanche, Service : Maladies respiratoires Not yet recruiting
Reims, France, 51092
Contact: Bruno Ravoninjatovo, Dr.    +33 6 09 27 05 75    bravoninjatovo@chu-reims.fr   
Principal Investigator: Bruno Ravoninjatovo, Dr.         
Germany
Children´s Hospital of the University Recruiting
Würzburg, Bavaria, Germany, 97080
Contact: Helge U Hebestreit, Prof. Dr.    +49 931 201 27728    hebestreit@uni-wuerzburg.de   
Principal Investigator: Helge U Hebestreit, Prof. Dr.         
CF- Ambulanz, Kinderklinik, Pädiatrische Pneumologie, Allergologie und Neonatologie Not yet recruiting
Hannover, Germany, 30625
Contact: Sibylle Junge, Dr.    +49 511 532 3220    Junge.Sibylle@mh-hannover.de   
Contact: Lothar Stein    +49 511 532 9217    Stein.Lothar@MH-Hannover.de   
Principal Investigator: Sibylle Junge, Dr.         
Switzerland
Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie Not yet recruiting
Bern, Switzerland
Contact: Carmen Casaulta, Dr.    +41 31 632 94 93    carmen.casaulta@insel.ch   
Principal Investigator: Carmen Casaulta, Dr.         
QuartierBleu, Praxis für Pneumologie am Lindenhofspital Not yet recruiting
Bern, Switzerland, 3001
Contact: Reta Fischer Biner, Dr.    +41 31 300 50 80    info@quartierbleu.ch   
Principal Investigator: Reta Fischer Biner, Dr.         
Kinderspital, Pneumologie Recruiting
Zurich, Switzerland, 8032
Contact: Alexander Möller, PD Dr.    +41 44 266 70 79    alexander.moeller@kispi.uzh.ch   
Principal Investigator: Alexander Möller, PD Dr.         
UniversitätsSpital, Klinik für Pneumologie Recruiting
Zurich, Switzerland, 8091
Contact: Christian Benden, PD Dr.    +41 44 255 41 83    christian.benden@usz.ch   
Principal Investigator: Christian Benden, PD Dr.         
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
Principal Investigator: Helge U Hebestreit, Dr. med. Wuerzburg University Hosptitals
  More Information

No publications provided

Responsible Party: Prof. Helge Hebestreit, Professor Dr. med., Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01744561     History of Changes
Other Study ID Numbers: ACT-CF-001
Study First Received: December 5, 2012
Last Updated: November 10, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Wuerzburg University Hospital:
Exercise
Motivation
Feedback
web-based diary
pedometer

Additional relevant MeSH terms:
Cystic Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014