EFFORT Asthma: Effects of Diet and Exercise in Asthma
- Conditions
- Asthma
- Interventions
- Behavioral: ExerciseBehavioral: Diet
- Registration Number
- NCT02355964
- Lead Sponsor
- University of Copenhagen
- Brief 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 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- >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)
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description exercise Exercise exercise (Aerobe training) 3 times per week Diet Diet A diet with an overall high protein content and a low glycemic index Diet+Exercise Exercise A diet with an overall high protein content and a low glycemic index combined with exercise (Aerobe training) 3 times per week. Diet+Exercise Diet A diet with an overall high protein content and a low glycemic index combined with exercise (Aerobe training) 3 times per week.
- Primary Outcome Measures
Name Time Method Asthma Control Questionnaire (Juniper) (ACQ). Within 10 days (+/- 1 day) of completing the intervention
- Secondary Outcome Measures
Name Time Method Airway hyperresponsiveness to mannitol, as measured by an airway provocation test. Within 10 days (+/- 1 day) of completing the intervention 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.
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. Within 10 days (+/- 1 day) of completing the intervention Fractional exhaled nitric oxide (FeNO) Within 10 days (+/- 1 day) of completing the intervention FeNO (a marker of eosinophilic inflammation)
Sputum inflammatory cell count Within 10 days (+/- 1 day) of completing the intervention Number and type of inflammatory cells in induced sputum
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. Within 10 days (+/- 1 day) of completing the intervention
Trial Locations
- Locations (1)
Respiratory Research Unit, Birpebjerg Hospital
🇩🇰Copenhagen NV, Denmark