Effects of a Partially Supervised Conditioning Program in CF

NCT01744561 | Completed DMC

• 1 other identifier: ACT-CF-001
• Study Type: interventional
• Target: 155
• Locations: 8 countries
• Sites: 28

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

Keywords

Exercise; Motivation; Feedback; web-based diary; pedometer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Change in peak oxygen uptake (%predicted)

  baseline to 6 months and baseline to 12 months

• Change in maximal aerobic power (%predicted)

  baseline to 6 months and baseline to 12 months

• Change in measured steps per day

  baseline to 6 months and baseline to 12 months

• Change in exercise steps per day

  baseline to 6 months and baseline to 12 months

• Change in reported physical activity

  baseline to 6 months and baseline to 12 months

Other Outcomes (5)

• Compliance with the exercise goal

  baseline to 6 months and baseline to 12 months

• Change in lung clearance index

  baseline to 6 months and baseline to 12 months

• Change in time spent in moderate-and-vigorous physical activity

  baseline to 6 months and baseline to 12 months

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Keep activity level constant

Interventions

Exercise Intervention 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.

Exercise Intervention

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (28)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-1212, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde,

Graz, 8036, Austria

Location

Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene

Innsbruck, 6020, Austria

Location

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

Monrtreal, Quebec, H4A 3J1, Canada

Location

Hôpital Renée Sabran, Service : Maladies respiratoires

Hyères, 83406, France

Location

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

Lille, 59037, France

Location

Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques

Lille, 59037, France

Location

Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires

Montpellier, 34295, France

Location

Hôpital Necker, Service : Pneumologie et allergologie pédiatriques

Paris, 75015, France

Location

Hôpital Maison Blanche, Service : Maladies respiratoires

Reims, 51092, France

Location

Olgahospital, Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, 70174, Germany

Location

Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Children´s Hospital of the University

Würzburg, Bavaria, 97080, Germany

Location

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

Bochum, 44791, Germany

Location

Klinik und Poliklinik für Kinderheilkunde - Universitäts-Mukoviszidose-Centrum

Dresden, 01307, Germany

Location

Christiane Herzog CF-Zentrum, Goethe Universität

Frankfurt, 60323, Germany

Location

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

Hamburg, 22763, Germany

Location

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

Hanover, 30625, Germany

Location

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

Mainz, 55101, Germany

Location

Praxis für Lungen- und Bronchialheilkunde

Munich, 81241, Germany

Location

Klinik für Kinder- und Jugendmedizin / Universitätsklinikum

Münster, 48149, Germany

Location

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

Utrecht, Netherlands

Location

QuartierBleu, Praxis für Pneumologie am Lindenhofspital

Bern, 3001, Switzerland

Location

Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie

Bern, Switzerland

Location

Kinderspital, Pneumologie

Zurich, 8032, Switzerland

Location

UniversitätsSpital, Klinik für Pneumologie

Zurich, 8091, Switzerland

Location

Royal Hospital for Sick Children

Edinburgh, Scottland, EH9 1LF, United Kingdom

Location

Related 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.

  PMID: 29422091 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Officials

• Helge U Hebestreit, Dr. med.

  Wuerzburg University Hosptitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 6, 2012
• Study Start: July 1, 2014
• Primary Completion: October 15, 2018
• Study Completion: October 15, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Locations

GB (1); AU (2); DE (11); NL (1); CA (1); CH (4); US (2); FR (6)