EFFORT Asthma: Effects of Diet and Exercise in Asthma

NCT ID: NCT02355964

Last Updated: 2016-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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exercise

exercise (Aerobe training) 3 times per week

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Aerobe exercise 3 times a week in 8 weeks

Diet

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

Group Type EXPERIMENTAL

Diet

Intervention Type BEHAVIORAL

Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks

Diet+Exercise

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

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Aerobe exercise 3 times a week in 8 weeks

Diet

Intervention Type BEHAVIORAL

Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks

control

Regular lifestyle (no intervention)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Aerobe exercise 3 times a week in 8 weeks

Intervention Type BEHAVIORAL

Diet

Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Louise Lindhardt Toennesen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vibeke Backer, Professor

Role: STUDY_CHAIR

Respiratory Research Unit, Bispebjerg hospital

Locations

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Respiratory Research Unit, Birpebjerg Hospital

Copenhagen NV, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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EFFORT Asthma

Identifier Type: -

Identifier Source: org_study_id

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