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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 September 2017 by Prof. Helge Hebestreit, 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: September 7, 2017
Last verified: September 2017
  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
Cystic Fibrosis Behavioral: Exercise Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Prof. Helge Hebestreit, 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 ]

Secondary Outcome Measures:
  • Change in peak oxygen uptake (%predicted) [ Time Frame: baseline to 6 months and baseline to 12 months ]
  • Change in maximal aerobic power (%predicted) [ Time Frame: baseline to 6 months and baseline to 12 months ]
  • Change in measured steps per day [ Time Frame: baseline to 6 months and baseline to 12 months ]
  • Change in exercise steps per day [ Time Frame: baseline to 6 months and baseline to 12 months ]
  • Change in reported physical activity [ Time Frame: baseline to 6 months and baseline to 12 months ]
  • Change in forced expiratory volume in 1 second (FEV1; %predicted) [ Time Frame: baseline to 6 months and baseline to 12 months ]
  • Change in forced vital capacity (FVC; % predicted) [ Time Frame: baseline to 6 months and baseline to 12 months ]
  • Change in residual volume in percent of total lung capacity (RV/TLC; %) [ Time Frame: baseline to 6 months and baseline to 12 months ]
  • Time to first exacerbation [ Time Frame: baseline to 6 months and baseline to 12 months ]
  • Number of upper respiratory tract infections [ Time Frame: baseline to 6 months and baseline to 12 months ]
    from diary

  • Days on additional oral / intravenous antibiotics [ Time Frame: baseline to 6 months and baseline to 12 months ]
    from questionnaire

  • Change in body mass index (kg/m2) [ Time Frame: baseline to 6 months and baseline to 12 months ]
  • Change in muscle mass (kg) [ Time Frame: baseline to 6 months and baseline to 12 months ]
    estimated from skinfold thickness

  • Change in percent body fat [ Time Frame: baseline to 6 months and baseline to 12 months ]
    estimated from skinfold thickness

  • Change in Quality of Life scales [ Time Frame: baseline to 6 months and baseline to 12 months ]
    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 ]
    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 ]
    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 ]
    causality as judged by investigator

  • Severe adverse events [ Time Frame: baseline to 6 months and baseline to 12 months ]
  • Serious adverse events [ Time Frame: baseline to 6 months and baseline to 12 months ]

Other Outcome Measures:
  • Compliance with the exercise goal [ Time Frame: baseline to 6 months and baseline to 12 months ]
    based on questionnaire and diary

  • Change in lung clearance index [ Time Frame: baseline to 6 months and baseline to 12 months ]
    based on nitrogen multiple breath washout, in selected centres only

  • Change in time spent in moderate-and-vigorous physical activity [ Time Frame: baseline to 6 months and baseline to 12 months ]
    based on accelerometry, in selected centres only

  • Change in bone mineral density and body composition [ Time Frame: baseline to 6 months and baseline to 12 months ]
    based on dual energy x-ray absorptiometry, in selected centres only

  • Change in mucociliary clearance with exercise [ Time Frame: baseline to 6 months ]
    based on nuclear medicine scans, US centres only


Estimated Enrollment: 292
Study Start Date: July 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-1212
Contact: John D Lowman, PT, PhD    205-934-5892    jlowman@uab.edu   
Contact: Margaret M Harviley    +1 205-934-4644    mmh@uab.edu   
Principal Investigator: John D Lowman, PT, PhD         
Sub-Investigator: Steven M Rowe, MD         
Sub-Investigator: Marcas M Bamman, PhD         
Sub-Investigator: Pradeep G Bhambhvani, MD         
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Paul J. Rebovich, MS    412-692-5873    paul.rebovich@chp.edu   
Contact: Elizabeth Hartigan, MPH, RN, CRM    +1 412-692-7060    elizabeth.hartigan@chp.edu   
Principal Investigator: David M. Orenstein, MD, MA         
Austria
Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde, Active, not recruiting
Graz, Austria, 8036
Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene Completed
Innsbruck, Austria, 6020
Canada, Quebec
Montreal Children's Hospital, McGill University Health Centre - Glen Site Recruiting
Monrtreal, Quebec, Canada, H4A 3J1
Contact: Daniel Aintabi    +1 514-412-4400 ext 22109    daniel.aintabi@mail.mcgill.ca   
Contact: Nancy Alarie, PT    +1 514-412-4400 ext 22109    nancy.alarie@muhc.mcgill.ca   
Principal Investigator: Larry Lands, MD, PhD         
Principal Investigator: Nancy Alarie, PT         
France
Hôpital Renée Sabran, Service : Maladies respiratoires 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 Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq Recruiting
Lille cedex, France, 59037
Contact: Anne Prevotat, MD    +33 3 20 44 59 48    anne.prevotat@chru-lille.fr   
Principal Investigator: Anne Prevotat, MD         
Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques 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 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.         
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 Recruiting
Reims, France, 51092
Contact: Bruno Ravoninjatovo, Dr.    +33 6 09 27 05 75    bravoninjatovo@chu-reims.fr   
Principal Investigator: Bruno Ravoninjatovo, Dr.         
Germany
Olgahospital, Klinikum Stuttgart Completed
Stuttgart, Baden-Württemberg, Germany, 70174
Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen Completed
Tübingen, Baden-Württemberg, Germany, 72076
Children´s Hospital of the University Completed
Würzburg, Bavaria, Germany, 97080
Pediatric Pulmonology and CF centre, Children´s Hospital, Ruhr University Completed
Bochum, Germany, 44791
Klinik und Poliklinik für Kinderheilkunde - Universitäts-Mukoviszidose-Centrum Active, not recruiting
Dresden, Germany, 01307
Christiane Herzog CF-Zentrum, Goethe Universität Completed
Frankfurt, Germany, 60323
CF Zentrum Hamburg-Altona, Kinderarztpraxis Runge, Sextro,Held Completed
Hamburg, Germany, 22763
CF- Ambulanz, Kinderklinik, Pädiatrische Pneumologie, Allergologie und Neonatologie Active, not recruiting
Hannover, Germany, 30625
Zentrum für Kinder- und Jugendmedizin, Pädiatrische Pneumologie, Allergologie und Mukoviszidose Completed
Mainz, Germany, 55101
Praxis für Lungen- und Bronchialheilkunde Completed
Munich, Germany, 81241
Klinik für Kinder- und Jugendmedizin / Universitätsklinikum Completed
Münster, Germany, 48149
Netherlands
University Medical Center, Child Development & Exercise Center, Wilhelmina Children's Hospital Recruiting
Utrecht, Netherlands
Contact: Erik HJ Hulzebos, PhD       H.Hulzebos@umcutrecht.nl   
Contact: Marcella Burghard       M.Burghard@umcutrecht.nl   
Principal Investigator: Erik HJ Hulzebos, PhD         
Switzerland
QuartierBleu, Praxis für Pneumologie am Lindenhofspital Completed
Bern, Switzerland, 3001
Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie Completed
Bern, Switzerland
Kinderspital, Pneumologie Completed
Zurich, Switzerland, 8032
UniversitätsSpital, Klinik für Pneumologie Completed
Zurich, Switzerland, 8091
United Kingdom
Royal Hospital for Sick Children Completed
Edinburgh, Scottland, United Kingdom, EH9 1LF
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
Principal Investigator: Helge U Hebestreit, Dr. med. Wuerzburg University Hosptitals
  More Information

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: September 7, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Helge Hebestreit, Wuerzburg University Hospital:
Exercise
Motivation
Feedback
web-based diary
pedometer

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

ClinicalTrials.gov processed this record on September 21, 2017