Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Effect of Physical Activity on NAFLD

23. mars 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Endurance Activity (EA)
The subjects have followed a program of endurance (aerobic) activity (EA).
Atferdsmessig: Endurance 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%.
Annen: EA + Resistance Training (RT)
The subjects have followed a program of endurance activity (EA) and resistance training (RT).
Atferdsmessig: EA + 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:

  • Walk (30 minutes): exercise intensity started from the 60% of the maximum heart rate and raised up to the 75%.
  • Musculation (30 minutes): training of the bigger muscle groups (chest, shoulders, arms, abdomen, back, glutei and legs). Exercise intensity started from the 65% of the maximum rated load and raised up to the 75%.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change from Baseline in NAFLD score at three and six months
Tidsramme: Six months
Six months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Etterforskere

  • Hovedetterforsker: Alberto R Osella, MD, PhD, IRRCS "Saverio De Bellis", Via Turi 27, 70013, Castellana Grotte (Bari), Italy

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2013

Primær fullføring (Faktiske)

1. september 2013

Studiet fullført (Faktiske)

1. desember 2013

Datoer for studieregistrering

Først innsendt

13. februar 2015

Først innsendt som oppfylte QC-kriteriene

13. februar 2015

Først lagt ut (Anslag)

20. februar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. mars 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mars 2015

Sist bekreftet

1. februar 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NUTRIEPATT

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på NAFLD

Kliniske studier på Endurance Activity (EA)

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Norway

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere