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Non-alcoholic Fatty Liver Disease (NAFLD)Phase 3NCT01418027

Combined Intensive and Conventional Exercise on Nonalcoholic Fatty Liver Disease (NAFLD)

A Phase 3 study testing Intensive exercise and Conventional exercise in people with Non-alcoholic Fatty Liver Disease (NAFLD), run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase of physical activity are recommended as an effective approach for the prevention and treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. Read more about this study

Who is it for?
Ages 40 to 65 years
What is being tested?
Intensive exercise and Conventional exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteChina
Study dates
Aug 2011to Dec 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Subjects with NAFLD determined by MRS ;
  2. Age 40-65 years old;
  3. Waist circumference> 90cm for men and > 85cm for women.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital Affiliated to Xiamen University

    Xiamen

Other trials in China

About this study

Official title: Combined Intensive and Conventional Exercise Intervention of Nonalcoholic Fatty Liver Disease

The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase of physical activity are recommended as an effective approach for the prevention and treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. In the present study we aim to compare the effect of intensive and conventional exercise interventions on NAFLD.

Being tested
Intensive exercise, Conventional exercise
Keywords
NAFLD, exercise, hepatic triglycerides
Medical subject headings
Non-alcoholic Fatty Liver Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive exerciseOther

    Subjects conduct an aerobic exercise at 65-80% maximum oxygen consumption for 30 minutes each day, five days a week, totally for 6 months.Subsequently, moderate physical activity(3.0-6.0 MET s) at 150 min/wk for 6 months.

  • Conventional exerciseOther

    Subjects receive moderate physical activity(3.0-6.0 MET s) at 150 min/wk(30 min per day, five days a week) for 12 months.

Study groups in NCT01418027
Study groupRoleWhat they receive
Intensive exerciseExperimentalThe subjects receive an intensive exercise for 6 months and a subsequent conventional exercise for another 6 months.
Receives: Other: Intensive exercise
Lifestyle counselingNo interventionSubjects receive a general lifestyle counseling for 12 months
Regular exerciseExperimentalSubjects receive conventional exercise for 12 months
Receives: Other: Conventional exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of intrahepatic triglyceride contents

    Measured: 12 months

Secondary outcomes (7)

  1. Change of body weight

    Measured: 12 months

  2. Change of waist circumference

    Measured: 12 months

  3. Change of body fat

    Measured: 12 months

  4. Change of abdominal fat

    Measured: 12 montshs

  5. Change of carotid intima-media thickness

    Measured: 12 months

  6. Change of cardiovascular risk factors (Blood pressure, lipids, glucose)

    Measured: 12 months

  7. Change of insulin resistance

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01418027
Sponsor's protocol ID
CCEMD011
Status last verified
Aug 2014
First submitted
15 Aug 2011
Last updated
1 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • Zhang HJ, He J, Pan LL, Ma ZM, Han CK, Chen CS, Chen Z, Han HW, Chen S, Sun Q, Zhang JF, Li ZB, Yang SY, Li XJ, Li XY. Effects of Moderate and Vigorous Exercise on Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. JAMA Intern Med. 2016 Aug 1;176(8):1074-82. doi: 10.1001/jamainternmed.2016.3202.

    PubMed 27379904

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intensive exercise and Conventional exercise in people with Non-alcoholic Fatty Liver Disease (NAFLD), run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of intrahepatic triglyceride contents (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01418027, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2014.

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