Cystic FibrosisACTIVATE-CFNCT01744561
Effects of a Partially Supervised Conditioning Program in CF
A study testing Exercise Intervention in people with Cystic Fibrosis, run by Wuerzburg University Hospital at 28 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 28 sitesin 8 countries
- Study dates
- 1 Jul 2014to 15 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Cystic Fibrosis
- Age ≥12 years
- Forced expiratory volume in 1 second (FEV1) ≥ 35% predicted
- Access to the internet
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
28 sites in 8 countries.
28 sites in 8 countries
Germany11 sites
Pediatric Pulmonology and CF centre, Children´s Hospital, Ruhr University
Bochum, 44791
Klinik und Poliklinik für Kinderheilkunde - Universitäts-Mukoviszidose-Centrum
Dresden, 01307
Christiane Herzog CF-Zentrum, Goethe Universität
Frankfurt, 60323
CF Zentrum Hamburg-Altona, Kinderarztpraxis Runge, Sextro,Held
Hamburg, 22763
CF- Ambulanz, Kinderklinik, Pädiatrische Pneumologie, Allergologie und Neonatologie
Hanover, 30625
Zentrum für Kinder- und Jugendmedizin, Pädiatrische Pneumologie, Allergologie und Mukoviszidose
Mainz, 55101
Praxis für Lungen- und Bronchialheilkunde
Munich, 81241
Klinik für Kinder- und Jugendmedizin / Universitätsklinikum
Münster, 48149
Olgahospital, Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, 70174
Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076
Children´s Hospital of the University
Würzburg, Bavaria, 97080
France6 sites
Hôpital Renée Sabran, Service : Maladies respiratoires
Hyères, 83406
Hôpital Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq
Lille, 59037
Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques
Lille, 59037
Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires
Montpellier, 34295
Hôpital Necker, Service : Pneumologie et allergologie pédiatriques
Paris, 75015
Hôpital Maison Blanche, Service : Maladies respiratoires
Reims, 51092
Switzerland4 sites
QuartierBleu, Praxis für Pneumologie am Lindenhofspital
Bern, 3001
Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie
Bern
Kinderspital, Pneumologie
Zurich, 8032
UniversitätsSpital, Klinik für Pneumologie
Zurich, 8091
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-1212
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Austria2 sites
Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde,
Graz, 8036
Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene
Innsbruck, 6020
Canada1 site
Montreal Children's Hospital, McGill University Health Centre - Glen Site
Monrtreal, Quebec, H4A 3J1
Netherlands1 site
University Medical Center, Child Development & Exercise Center, Wilhelmina Children's Hospital
Utrecht
United Kingdom1 site
Royal Hospital for Sick Children
Edinburgh, Scottland, EH9 1LF
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Exercise Intervention
- Keywords
- Exercise, Motivation, Feedback, web-based diary, pedometer
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise Intervention |
| Control | No intervention | Keep activity level constant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6 months
Secondary outcomes (20)
Change in peak oxygen uptake (%predicted)
Measured: baseline to 6 months and baseline to 12 months
Change in maximal aerobic power (%predicted)
Measured: baseline to 6 months and baseline to 12 months
Change in measured steps per day
Measured: baseline to 6 months and baseline to 12 months
Change in exercise steps per day
Measured: baseline to 6 months and baseline to 12 months
Change in reported physical activity
Measured: baseline to 6 months and baseline to 12 months
Change in forced expiratory volume in 1 second (FEV1; %predicted)
Measured: baseline to 6 months and baseline to 12 months
Change in forced vital capacity (FVC; % predicted)
Measured: baseline to 6 months and baseline to 12 months
Change in residual volume in percent of total lung capacity (RV/TLC; %)
Measured: baseline to 6 months and baseline to 12 months
Time to first exacerbation
Measured: baseline to 6 months and baseline to 12 months
Number of upper respiratory tract infections
from diary
Measured: baseline to 6 months and baseline to 12 months
Days on additional oral / intravenous antibiotics
from questionnaire
Measured: baseline to 6 months and baseline to 12 months
Change in body mass index (kg/m2)
Measured: baseline to 6 months and baseline to 12 months
Change in muscle mass (kg)
estimated from skinfold thickness
Measured: baseline to 6 months and baseline to 12 months
Change in percent body fat
estimated from skinfold thickness
Measured: baseline to 6 months and baseline to 12 months
Change in Quality of Life scales
from the revised Cystic Fibrosis health-related quality of life Questionnaire (CFQ-R questionnaire)
Measured: baseline to 6 months and baseline to 12 months
Change in depression, anxiety and stress scores
from Depression Anxiety Stress Scales
Measured: baseline to 6 months and baseline to 12 months
Change in plasma glucose concentrations 1 and 2 hours after a standardized glucose load
standardized oral glucose tolerance test only patients without diabetes mellitus
Measured: baseline to 9 months
Adverse events possibly or likely related to exercise
causality as judged by investigator
Measured: baseline to 6 months and baseline to 12 months
Severe adverse events
Measured: baseline to 6 months and baseline to 12 months
Serious adverse events
Measured: baseline to 6 months and baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study start1 Jul 2014
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Helge Hebestreit, Wuerzburg University Hospital
- Investigators
- Helge U Hebestreit, Dr. med., Principal investigator, Wuerzburg University Hosptitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744561
- Sponsor's protocol ID
- ACT-CF-001
- Acronym
- ACTIVATE-CF
- Status last verified
- Oct 2018
- First submitted
- 5 Dec 2012
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29422091
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Partially Supervised Conditioning Program in CF: an International Multi-centre, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01744561
- Acronym / sponsor ID
- ACTIVATE-CF / ACT-CF-001
- Conditions
- Cystic Fibrosis
- Keywords
- Exercise, Motivation, Feedback, web-based diary, pedometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise InterventionAdd 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. |
| Control | No intervention | –Keep activity level constant |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of Cystic Fibrosis
- Age ≥12 years
- Forced expiratory volume in 1 second (FEV1) ≥ 35% predicted
- Access to the internet
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionAdd 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. | Behavioural | Exercise Intervention |
Primary outcome
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
20 secondary outcomes
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
Days on additional oral / intravenous antibiotics
Time frame: 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
Change in muscle mass (kg)
Time frame: 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
Change in Quality of Life scales
Time frame: 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
Change in plasma glucose concentrations 1 and 2 hours after a standardized glucose load
Time frame: baseline to 9 months
Adverse events possibly or likely related to exercise
Time frame: baseline to 6 months and baseline to 12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Background: PubMed 29422091Hebestreit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helge U Hebestreit, Dr. med. principal investigator
Wuerzburg University Hosptitals
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Cystic Fibrosis, run by Wuerzburg University Hospital at 28 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany, France, Switzerland, United States, Austria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01744561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.