NCT01264198

Brief Summary

The aim of the study is to evaluate the effect of RT on clinical and metabolic parameters in patients with NAFLD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 27, 2014

Status Verified

December 1, 2010

Enrollment Period

1.8 years

First QC Date

July 6, 2010

Last Update Submit

March 26, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • The HRI value will be reduced in the intervention arm as compared to the The The change in Hepato-Renal Index (HRI) evaluated by ultrasound (US).

    week 0 and week 13

Study Arms (2)

Stretching Exercises

SHAM COMPARATOR

The patients will perform twice weekly home based static stretching workout.

Behavioral: Resistance Training

Resistance Training

EXPERIMENTAL

The patients will perform twice weekly supervised RT for 3 months

Behavioral: Resistance Training

Interventions

Supervised Resistance Training

Resistance TrainingStretching Exercises

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ultrasound diagnosed fatty liver.

You may not qualify if:

  • Presence of HBsAg or anti-HCV antibodies (will be obtained from blood tests at the liver clinic).
  • Patients with known diabetes treated with antidiabetic medications.
  • Patients with known kidney disease, CHD, lung disease, inflammatory bowel disease.
  • Excessive alcohol consumption ≥ 30 g/day in men or 20 g/ day in women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical center

Tel Aviv, 64239, Israel

Location

Related Publications (1)

  • Zelber-Sagi S, Azar S, Nemirovski A, Webb M, Halpern Z, Shibolet O, Tam J. Serum levels of endocannabinoids are independently associated with nonalcoholic fatty liver disease. Obesity (Silver Spring). 2017 Jan;25(1):94-101. doi: 10.1002/oby.21687. Epub 2016 Nov 15.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ran Oren, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 6, 2010

First Posted

December 21, 2010

Study Start

December 1, 2010

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

March 27, 2014

Record last verified: 2010-12

Locations