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

October 18, 2018 updated by: Prof. Helge Hebestreit, Wuerzburg University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde,
      • Innsbruck, Austria, 6020
        • Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene
  • Canada
    • Quebec
      • Monrtreal, Quebec, Canada, H4A 3J1
        • Montreal Children's Hospital, McGill University Health Centre - Glen Site
  • France
      • Hyeres, France, 83406
        • Hôpital Renée Sabran, Service : Maladies respiratoires
      • Lille cedex, France, 59037
        • Hôpital Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq
      • Lille cedex, France, 59037
        • Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques
      • Montpellier cedex 5, France, 34295
        • Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires
      • Paris, France, 75015
        • Hôpital Necker, Service : Pneumologie et allergologie pédiatriques
      • Reims, France, 51092
        • Hôpital Maison Blanche, Service : Maladies respiratoires
  • Germany
      • Bochum, Germany, 44791
        • Pediatric Pulmonology and CF centre, Children´s Hospital, Ruhr University
      • Dresden, Germany, 01307
        • Klinik und Poliklinik für Kinderheilkunde - Universitäts-Mukoviszidose-Centrum
      • Frankfurt, Germany, 60323
        • Christiane Herzog CF-Zentrum, Goethe Universität
      • Hamburg, Germany, 22763
        • CF Zentrum Hamburg-Altona, Kinderarztpraxis Runge, Sextro,Held
      • Hannover, Germany, 30625
        • CF- Ambulanz, Kinderklinik, Pädiatrische Pneumologie, Allergologie und Neonatologie
      • Mainz, Germany, 55101
        • Zentrum für Kinder- und Jugendmedizin, Pädiatrische Pneumologie, Allergologie und Mukoviszidose
      • Munich, Germany, 81241
        • Praxis für Lungen- und Bronchialheilkunde
      • Münster, Germany, 48149
        • Klinik für Kinder- und Jugendmedizin / Universitätsklinikum
    • Baden-Württemberg
      • Stuttgart, Baden-Württemberg, Germany, 70174
        • Olgahospital, Klinikum Stuttgart
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Children´s Hospital of the University
  • Netherlands
      • Utrecht, Netherlands
        • University Medical Center, Child Development & Exercise Center, Wilhelmina Children's Hospital
  • Switzerland
      • Bern, Switzerland, 3001
        • QuartierBleu, Praxis für Pneumologie am Lindenhofspital
      • Bern, Switzerland
        • Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie
      • Zurich, Switzerland, 8032
        • Kinderspital, Pneumologie
      • Zurich, Switzerland, 8091
        • UniversitätsSpital, Klinik für Pneumologie
  • United Kingdom
    • Scottland
      • Edinburgh, Scottland, United Kingdom, EH9 1LF
        • Royal Hospital for Sick Children
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-1212
        • University of Alabama at Birmingham
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh of UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
baseline and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in peak oxygen uptake (%predicted)
Time Frame: baseline to 6 months and baseline to 12 months
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
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
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
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
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
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
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
baseline to 6 months and baseline to 12 months
Time to first exacerbation
Time Frame: baseline to 6 months and baseline to 12 months
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
baseline to 6 months and baseline to 12 months
Days on additional oral / intravenous antibiotics
Time Frame: baseline to 6 months and baseline to 12 months
from questionnaire
baseline to 6 months and baseline to 12 months
Change in body mass index (kg/m2)
Time Frame: baseline to 6 months and baseline to 12 months
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
baseline to 6 months and baseline to 12 months
Change in percent body fat
Time Frame: baseline to 6 months and baseline to 12 months
estimated from skinfold thickness
baseline to 6 months and baseline to 12 months
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)
baseline to 6 months and baseline to 12 months
Change in depression, anxiety and stress scores
Time Frame: baseline to 6 months and baseline to 12 months
from Depression Anxiety Stress Scales
baseline to 6 months and baseline to 12 months
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
baseline to 9 months
Adverse events possibly or likely related to exercise
Time Frame: baseline to 6 months and baseline to 12 months
causality as judged by investigator
baseline to 6 months and baseline to 12 months
Severe adverse events
Time Frame: baseline to 6 months and baseline to 12 months
baseline to 6 months and baseline to 12 months
Serious adverse events
Time Frame: baseline to 6 months and baseline to 12 months
baseline to 6 months and baseline to 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compliance with the exercise goal
Time Frame: baseline to 6 months and baseline to 12 months
based on questionnaire and diary
baseline to 6 months and baseline to 12 months
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
baseline to 6 months and baseline to 12 months
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
baseline to 6 months and baseline to 12 months
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
baseline to 6 months and baseline to 12 months
Change in mucociliary clearance with exercise
Time Frame: baseline to 6 months
based on nuclear medicine scans, US centres only
baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuerzburg University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Helge U Hebestreit, Dr. med., Wuerzburg University Hosptitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACT-CF-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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