NCT02427087

Brief Summary

Were included 40 patients with NAFLD followed at the Ambulatory of Non-alcoholic Fatty Liver Disease , Discipline of Clinical Gastroenterology, Clinic Hospital of the Medical School of the University of Sao Paulo (HC-FMUSP). Were included adults women of any race, aged 35 to 75 years, diagnosed with NAFLD and were followed for a period of six months. All patients underwent anthropometric and body composition, as well as analysis of clinical, laboratory before and after 6 months of exercise training protocol established. The hypothesis of our research is that aerobic activity had a favorable impact on NAFLD. It is expected that the intervention of physical activity causes a decrease or no weight, decreased levels of aminotransferases, decreased insulin resistance assessed by homeostasis model assessment (HOMA) index and consequently decrease or reversal of hepatic steatosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2015

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

March 4, 2015

Last Update Submit

April 24, 2015

Conditions

Fatty Liver

Keywords

Nonalcoholic fatty liverPhysical activityNAFLDAnthropometryBody Composition

Outcome Measures

Primary Outcomes (1)

  • Efficacy in reduce inflammatory component of NASH for transient elastography liver

    Determine the efficacy of the physical activity in reducing the systemic inflammatory component of NASH in patients with NAFLD for transient elastography liver, FibroScan (FS) \[stiffness liver (SL) /CAP\]

    6 months

Secondary Outcomes (1)

  • Inflammatory systemic profile

    6 months

Study Arms (2)

Continuous Aerobic training

ACTIVE COMPARATOR

Aerobic training continuous (n=19 patients) carry a protocol continuous aerobic training twice a week for 24 weeks and the session will last 60 minutes/2 days/week with recommendation for healthy diet.

Behavioral: Continuous Aerobic Training twiceBehavioral: Healthy Diet

Healthy diet

ACTIVE COMPARATOR

Diet group (n=21 patients) only recommendation for healthy diet.

Behavioral: Healthy Diet

Interventions

Continuous Aerobic Training twiceBEHAVIORAL

Supervised aerobic exercise program of 60 min/2 days/week at 60-85% of heart rate reserve for 24 weeks and healthy diet

Continuous Aerobic training
Healthy DietBEHAVIORAL

Diet group (21) Recommendation for healthy diet.

Continuous Aerobic trainingHealthy diet

Eligibility Criteria

Age35 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age, Female
  • Biopsy-liver until 24 months previous that prove NAFLD or NASH
  • Patients who agree to participate in the study and all signed informed consent.

You may not qualify if:

  • Presence of alcoholism \<20g (women) of ethanol/day, drugs, schistosomiasis, hepatitis B or C and other chronic liver diseases cause determined
  • Without medical clearance for physical activity
  • Without availability to attend appointments and physical activities 2x/week
  • Significant change in dietary habits and/or exercise in the last 3 months that resulted in weight loss \> 5%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo School of Medicine

São Paulo, São Paulo, 01246903, Brazil

Location

MeSH Terms

Conditions

Fatty LiverNon-alcoholic Fatty Liver DiseaseMotor Activity

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBehavior

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • CLAUDIA PM MD OLIVEIRA, PhD

    University of Sao Paulo, School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 4, 2015

First Posted

April 27, 2015

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 27, 2015

Record last verified: 2015-04

Locations

BR(1)