EFFORT Asthma: Effects of Diet and Exercise in Asthma

University of Copenhagen

Status: Completed

Conditions: Asthma

Treatments: Behavioral: Diet; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02355964

EFFORT Asthma

Details and patient eligibility

About

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.

Full 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

Enrollment: 149 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >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)

Exclusion criteria

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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149 participants in 4 patient groups

exercise

Experimental group

Description:

exercise (Aerobe training) 3 times per week

Treatment:

Behavioral: Exercise

Diet

Experimental group

Description:

A diet with an overall high protein content and a low glycemic index

Treatment:

Behavioral: Diet

Diet+Exercise

Experimental group

Description:

A diet with an overall high protein content and a low glycemic index combined with exercise (Aerobe training) 3 times per week.

Treatment:

Behavioral: Diet

Behavioral: Exercise

control

No Intervention group

Description:

Regular lifestyle (no intervention)