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Completed

NCT Number: NCT02367742

Effect of Physical Activity on 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.

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Key information

Conditions

NAFLD Behavior Digestive System Diseases Fatty Liver Liver Diseases Motor Activity Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not enrolled in the previous trial called NUTRIEP

Treatment and study plan

Endurance Activity (EA)

Behavioral

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%.

EA + Resistance Training (RT)

Behavioral

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%.

Primary outcomes

  1. Change from Baseline in NAFLD score at three and six months

    Time frame: Six months

Secondary outcomes

  1. Change from Baseline in Indirect calorimetry at three and six months

    Time frame: Six months

  2. Percentage Change from Baseline in Bioimpedenziometry at three and six months

    Time frame: Six months

    Percentage reduction in Fat Mass; Percentage increase in Muscle mass

Other outcomes

  1. Height

    Time frame: At baseline

  2. Change from Baseline in Body Weight at three and six months

    Time frame: Six months

  3. Change from Baseline in Systolic blood pressure at three and six months

    Time frame: Six months

  4. Change from Baseline in Diastolic blood pressure at three and six months

    Time frame: Six months

  5. Change from Baseline in Serum Fasting Glucose at three and six months

    Time frame: Six months

  6. Change from Baseline in Serum GOT at three and six months

    Time frame: Six months

  7. Change from Baseline in Serum GPT at three and six months

    Time frame: Six months

  8. Change from Baseline in Serum gamma-GT at three and six months

    Time frame: Six months

  9. Change from Baseline in Serum Cholesterol at three and six months

    Time frame: Six months

  10. Change from Baseline in Serum HDL Cholesterol at three and six months

    Time frame: Six months

  11. Change from Baseline in Serum Triglycerides at three and six months

    Time frame: Six months

  12. Change from Baseline in Serum Insulin at three and six months Insulin

    Time frame: Six months

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Other

Registry information

Official study title

Effect of Two Different Programs of Physical Activity on the Grade of Severity of NAFLD

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2015
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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