EFFORT Asthma: Effects of Diet and Exercise in Asthma (EFFORT)
27. juli 2016 opdateret af: Louise Lindhardt Toennesen, University of Copenhagen
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
149
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Copenhagen NV, Danmark, 2400
- Respiratory Research Unit, Birpebjerg Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: exercise
exercise (Aerobe training) 3 times per week
|
Aerobe exercise 3 times a week in 8 weeks
|
|
Eksperimentel: Diet
A diet with an overall high protein content and a low glycemic index
|
Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks
|
|
Eksperimentel: Diet+Exercise
A diet with an overall high protein content and a low glycemic index combined with exercise (Aerobe training) 3 times per week.
|
Aerobe exercise 3 times a week in 8 weeks
Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks
|
|
Ingen indgriben: control
Regular lifestyle (no intervention)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Asthma Control Questionnaire (Juniper) (ACQ).
Tidsramme: Within 10 days (+/- 1 day) of completing the intervention
|
Within 10 days (+/- 1 day) of completing the intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Airway hyperresponsiveness to mannitol, as measured by an airway provocation test.
Tidsramme: 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.
|
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.
Tidsramme: Within 10 days (+/- 1 day) of completing the intervention
|
Within 10 days (+/- 1 day) of completing the intervention
|
|
|
Fractional exhaled nitric oxide (FeNO)
Tidsramme: Within 10 days (+/- 1 day) of completing the intervention
|
FeNO (a marker of eosinophilic inflammation)
|
Within 10 days (+/- 1 day) of completing the intervention
|
|
Sputum inflammatory cell count
Tidsramme: Within 10 days (+/- 1 day) of completing the intervention
|
Number and type of inflammatory cells in induced sputum
|
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.
Tidsramme: Within 10 days (+/- 1 day) of completing the intervention
|
Within 10 days (+/- 1 day) of completing the intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Vibeke Backer, Professor, Respiratory Research Unit, Bispebjerg Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2015
Primær færdiggørelse (Faktiske)
1. juli 2016
Studieafslutning (Faktiske)
1. juli 2016
Datoer for studieregistrering
Først indsendt
16. januar 2015
Først indsendt, der opfyldte QC-kriterier
30. januar 2015
Først opslået (Skøn)
4. februar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. juli 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EFFORT Asthma
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .