Effect of Physical Activity on NAFLD
23. marts 2015 opdateret af: Alberto R Osella, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Effect of Two Different Programs of Physical Activity on the Grade of Severity of NAFLD
It has been demonstrated the essential role of physical activity in the prevention of overweight and obesity.
Nevertheless, the effect of a program of physical activity on the maintenance of body weight in subjects who have previously followed a dietary intervention is still unknown.
The aim of this study was to investigate this topic by evaluating the effect of two different programs of physical activity on subjects who have followed a dietary intervention but presented again NAFLD a year after the treatment.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Subjects who were previously enrolled in the trial NUTRIEP and who still have NAFLD a year after the end of the study, were invited to participate in a program of physical activity to assess the effect of endurance and resistance training on weight and NAFLD score.
Participants (100 subjects) were randomized and divided into two groups: the first followed a program of endurance activity consisting in a 30 minute walk, 5 times/week; the second followed a program combining the just described aerobic exercise with a resistance training based on 30 minute of musculation involving all the bigger muscles, 3 times/week.
The trial lasted six months and subjects underwent liver ultrasonography (to assess NAFLD score), indirect calorimetry, bioimpedenziometry, the measurement of anthropometric variables (body height and weight) and biological parameters (glucose, insulin, cholesterol, HDL cholesterol, triglycerides, GOT, GPT and GGT) at the baseline and at the third and the sixth month.
The aim of the study was to estimate the effect of the two different programs of physical activity on NAFLD score.
Secondary end-points included: the effect on basal metabolism, the modification of fat mass (FM), lean mass (LM) and muscle mass (MM) and on several biological markers associated with NAFLD.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Ikke anvendelig
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Moderate or severe NAFLD
- Enrolled in the previous trial called NUTRIEP
Exclusion Criteria:
- Not enrolled in the previous trial called NUTRIEP
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 |
|---|---|
|
Andet: Endurance Activity (EA)
The subjects have followed a program of endurance (aerobic) activity (EA).
|
Subjects have followed a program of endurance activity consisting in a 30 minute walk, 5 times/week.
Exercise intensity started from the 60% of the maximum heart rate and raised up to the 75%.
|
|
Andet: EA + Resistance Training (RT)
The subjects have followed a program of endurance activity (EA) and resistance training (RT).
|
Subjects have followed a program combining endurance activity (EA) and resistance training (RT) consisting in a 60 minute work session, 3 times/week consisting in:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from Baseline in NAFLD score at three and six months
Tidsramme: Six months
|
Six months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Indirect calorimetry at three and six months
Tidsramme: Six months
|
Six months
|
|
|
Percentage Change from Baseline in Bioimpedenziometry at three and six months
Tidsramme: Six months
|
Percentage reduction in Fat Mass; Percentage increase in Muscle mass
|
Six months
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Height
Tidsramme: At baseline
|
At baseline
|
|
Change from Baseline in Body Weight at three and six months
Tidsramme: Six months
|
Six months
|
|
Change from Baseline in Systolic blood pressure at three and six months
Tidsramme: Six months
|
Six months
|
|
Change from Baseline in Diastolic blood pressure at three and six months
Tidsramme: Six months
|
Six months
|
|
Change from Baseline in Serum Fasting Glucose at three and six months
Tidsramme: Six months
|
Six months
|
|
Change from Baseline in Serum GOT at three and six months
Tidsramme: Six months
|
Six months
|
|
Change from Baseline in Serum GPT at three and six months
Tidsramme: Six months
|
Six months
|
|
Change from Baseline in Serum gamma-GT at three and six months
Tidsramme: Six months
|
Six months
|
|
Change from Baseline in Serum Cholesterol at three and six months
Tidsramme: Six months
|
Six months
|
|
Change from Baseline in Serum HDL Cholesterol at three and six months
Tidsramme: Six months
|
Six months
|
|
Change from Baseline in Serum Triglycerides at three and six months
Tidsramme: Six months
|
Six months
|
|
Change from Baseline in Serum Insulin at three and six months Insulin
Tidsramme: Six months
|
Six months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Alberto R Osella, MD, PhD, IRRCS "Saverio De Bellis", Via Turi 27, 70013, Castellana Grotte (Bari), Italy
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 2013
Primær færdiggørelse (Faktiske)
1. september 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
13. februar 2015
Først indsendt, der opfyldte QC-kriterier
13. februar 2015
Først opslået (Skøn)
20. februar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. marts 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. marts 2015
Sidst verificeret
1. februar 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NUTRIEPATT
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 .