Clinical trial NCT02367742: Effect of Physical Activity on NAFLD
Official title: Effect of Two Different Programs of Physical Activity on the Grade of Severity of NAFLD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Keywords: Diet
Physical Activity
NAFLD
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Moderate or severe NAFLD
* Enrolled in the previous trial called NUTRIEP

Exclusion Criteria:

* Not enrolled in the previous trial called NUTRIEP

Primary outcomes:
measure: Change from Baseline in NAFLD score at three and six months
timeFrame: Six months
Secondary outcomes:
measure: Change from Baseline in Indirect calorimetry at three and six months
timeFrame: Six months
measure: Percentage Change from Baseline in Bioimpedenziometry at three and six months
timeFrame: Six months
Other outcomes:
measure: Height
timeFrame: At baseline
measure: Change from Baseline in Body Weight at three and six months
timeFrame: Six months
measure: Change from Baseline in Systolic blood pressure at three and six months
timeFrame: Six months
measure: Change from Baseline in Diastolic blood pressure at three and six months
timeFrame: Six months
measure: Change from Baseline in Serum Fasting Glucose at three and six months
timeFrame: Six months
measure: Change from Baseline in Serum GOT at three and six months
timeFrame: Six months
measure: Change from Baseline in Serum GPT at three and six months
timeFrame: Six months
measure: Change from Baseline in Serum gamma-GT at three and six months
timeFrame: Six months
measure: Change from Baseline in Serum Cholesterol at three and six months
timeFrame: Six months
measure: Change from Baseline in Serum HDL Cholesterol at three and six months
timeFrame: Six months
measure: Change from Baseline in Serum Triglycerides at three and six months
timeFrame: Six months
measure: Change from Baseline in Serum Insulin at three and six months Insulin
timeFrame: Six months
Locations:
Study officials:
affiliation: IRRCS "Saverio De Bellis", Via Turi 27, 70013, Castellana Grotte (Bari), Italy
name: Alberto R Osella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: