AsthmaEFFORTNCT02355964
EFFORT Asthma: Effects of Diet and Exercise in Asthma
A study testing Exercise and Diet in people with Asthma, run by University of Copenhagen at 1 site in Denmark.
Trial summary
This project aims to study the effects of lifestyle changes on asthma and systemic inflammation in a randomized clinical trial of diet and exercise. The project is a multidisciplinary collaboration in the areas of medicine, physiology and nutrition, centred on improving asthma control in non-obese sedentary asthmatics… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Exercise and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Jul 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- Uncontrolled or partly uncontrolled asthma
- Capable of exercising on bike
- Sedentary (currently do less than 60 min of structured/planned physical activity per week)
Who cannot join
- BMI ≥ 30.0 or <20.5
- Chronic obstructive pulmonary disease (COPD), pregnancy, other inflammatory or metabolic diseases
- The use of oral anti-inflammatory medication or the use of antibiotic treatment during the last 8 weeks.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Respiratory Research Unit, Birpebjerg Hospital
Copenhagen NV, 2400
About this study
Official title: EFFORT Asthma: Effects of a High Protein/Low Glycemic Index Diet and Physical Exercise in Sedentary Non-obese Asthmatics.
This project aims to study the effects of lifestyle changes on asthma and systemic inflammation in a randomized clinical trial of diet and exercise. The project is a multidisciplinary collaboration in the areas of medicine, physiology and nutrition, centred on improving asthma control in non-obese sedentary asthmatics via simple means.
Read the detailed description
After screening and enrollment, a total of 200 Danish sedentary, non-obese asthma patients will be randomized to one of four groups: 1) control group (no intervention), 2) physical exercise intervention, 3) diet intervention (a diet with an overall high content of protein and a low glycemic index) or 4) exercise plus diet intervention.
Asthma is defined as respiratory symptoms and at least one positive asthma test. Patients will continue their regular doses of anti-asthma treatment unchanged throughout the study period. Type of anti-inflammatory medicine will be recorded and the adherence to the therapy will be assessed before the intervention period and at follow-up using questionnaires
- Conditions
- Asthma
- Being tested
- Exercise, Diet
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Aerobe exercise 3 times a week in 8 weeks
DietBehavioural
Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | exercise (Aerobe training) 3 times per week Receives: Behavioral: Exercise |
| Diet | Experimental | A diet with an overall high protein content and a low glycemic index Receives: Behavioral: Diet |
| Diet+Exercise | Experimental | A diet with an overall high protein content and a low glycemic index combined with exercise (Aerobe training) 3 times per week. Receives: Behavioral: Exercise; Behavioral: Diet |
| control | No intervention | Regular lifestyle (no intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire (Juniper) (ACQ).
Measured: Within 10 days (+/- 1 day) of completing the intervention
Secondary outcomes (5)
Airway hyperresponsiveness to mannitol, as measured by an airway provocation test.
The response-dose-ratio (RDR) will be calculated as the percentage fall in forced expiratory volume in 1 second (FEV1) after the last dose of inhaled dried mannitol powder delivered, divided by the cumulative dose of inhaled mannitol.
Measured: Within 10 days (+/- 1 day) of completing the intervention
Systemic low-grade inflammation, as measured by serum-levels (in microgram/ml) of high sensitivity C-reactive protein, interleukin 6 (IL-6), IL-8, tumor necrosis factor alpha (TNF-alpha) and leptin.
Measured: Within 10 days (+/- 1 day) of completing the intervention
Fractional exhaled nitric oxide (FeNO)
FeNO (a marker of eosinophilic inflammation)
Measured: Within 10 days (+/- 1 day) of completing the intervention
Sputum inflammatory cell count
Number and type of inflammatory cells in induced sputum
Measured: Within 10 days (+/- 1 day) of completing the intervention
Adipose tissue inflammatory properties as measured by levels of messenger ribonucleic acid (mRNA) of IL-6, IL-8, leptin and TNF-alpha in abdominal fat biopsies.
Measured: Within 10 days (+/- 1 day) of completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Lindhardt Toennesen, University of Copenhagen
- Investigators
- Vibeke Backer, Professor, Study chair, Respiratory Research Unit, Bispebjerg hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355964
- Sponsor's protocol ID
- EFFORT Asthma
- Acronym
- EFFORT
- Status last verified
- Jul 2016
- First submitted
- 16 Jan 2015
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFORT Asthma: Effects of a High Protein/Low Glycemic Index Diet and Physical Exercise in Sedentary Non-obese Asthmatics.
- ClinicalTrials.gov ID
- NCT02355964
- Acronym / sponsor ID
- EFFORT / EFFORT Asthma
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 Feb 2015 (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.
This project aims to study the effects of lifestyle changes on asthma and systemic inflammation in a randomized clinical trial of diet and exercise. The project is a multidisciplinary collaboration in the areas of medicine, physiology and nutrition, centred on improving asthma control in non-obese sedentary asthmatics via simple means.
Detailed description
After screening and enrollment, a total of 200 Danish sedentary, non-obese asthma patients will be randomized to one of four groups: 1) control group (no intervention), 2) physical exercise intervention, 3) diet intervention (a diet with an overall high content of protein and a low glycemic index) or 4) exercise plus diet intervention.
Asthma is defined as respiratory symptoms and at least one positive asthma test. Patients will continue their regular doses of anti-asthma treatment unchanged throughout the study period. Type of anti-inflammatory medicine will be recorded and the adherence to the therapy will be assessed before the intervention period and at follow-up using questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Behavioral: Exerciseexercise (Aerobe training) 3 times per week |
| Diet | Experimental | Behavioral: DietA diet with an overall high protein content and a low glycemic index |
| Diet+Exercise | Experimental | Behavioral: Exercise, Behavioral: DietA diet with an overall high protein content and a low glycemic index combined with exercise (Aerobe training) 3 times per week. |
| control | No intervention | –Regular lifestyle (no intervention) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years old
- Uncontrolled or partly uncontrolled asthma
- Capable of exercising on bike
- Sedentary (currently do less than 60 min of structured/planned physical activity per week)
Key exclusion criteria (3 listed)
- BMI ≥ 30.0 or <20.5
- Chronic obstructive pulmonary disease (COPD), pregnancy, other inflammatory or metabolic diseases
- The use of oral anti-inflammatory medication or the use of antibiotic treatment during the last 8 weeks.
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 |
|---|---|---|
| ExerciseAerobe exercise 3 times a week in 8 weeks | Behavioural | Diet+Exercise, exercise |
| DietDiet (a diet with an overall high protein content and a low glycemic index) in 8 weeks | Behavioural | Diet, Diet+Exercise |
Primary outcome
Asthma Control Questionnaire (Juniper) (ACQ).
Time frame: Within 10 days (+/- 1 day) of completing the intervention
5 secondary outcomes
Airway hyperresponsiveness to mannitol, as measured by an airway provocation test.
Time frame: Within 10 days (+/- 1 day) of completing the intervention
Systemic low-grade inflammation, as measured by serum-levels (in microgram/ml) of high sensitivity C-reactive protein, interleukin 6 (IL-6), IL-8, tumor necrosis factor alpha (TNF-alpha) and leptin.
Time frame: Within 10 days (+/- 1 day) of completing the intervention
Fractional exhaled nitric oxide (FeNO)
Time frame: Within 10 days (+/- 1 day) of completing the intervention
Sputum inflammatory cell count
Time frame: Within 10 days (+/- 1 day) of completing the intervention
Adipose tissue inflammatory properties as measured by levels of messenger ribonucleic acid (mRNA) of IL-6, IL-8, leptin and TNF-alpha in abdominal fat biopsies.
Time frame: Within 10 days (+/- 1 day) of completing the intervention
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 28 Jul 2016.
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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.
Vibeke Backer, Professor study chair
Respiratory Research Unit, Bispebjerg hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Diet in people with Asthma, run by University of Copenhagen at 1 site in Denmark.
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 3 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 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Asthma Control Questionnaire (Juniper) (ACQ). (time frame: Within 10 days (+/- 1 day) of completing the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2016.