NAFLDNCT02367742
Effect of Physical Activity on NAFLD
A study testing Endurance Activity (EA) and EA + Resistance Training (RT) in people with NAFLD, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD
- What is being tested?
- Endurance Activity (EA) and EA + Resistance Training (RT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate or severe NAFLD
- Enrolled in the previous trial called NUTRIEP
Who cannot join
- Not enrolled in the previous trial called NUTRIEP
About this study
Official title: Effect of Two Different Programs of Physical Activity on the Grade of Severity of 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.
Read the 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.
- Conditions
- NAFLD
- Being tested
- Endurance Activity (EA), EA + Resistance Training (RT)
- Keywords
- Diet, Physical Activity, NAFLD
- 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.
Endurance Activity (EA)Behavioural
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)Behavioural
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%.
| Study group | Role | What they receive |
|---|---|---|
| Endurance Activity (EA) | Other | The subjects have followed a program of endurance (aerobic) activity (EA). Receives: Behavioral: Endurance Activity (EA) |
| EA + Resistance Training (RT) | Other | The subjects have followed a program of endurance activity (EA) and resistance training (RT). Receives: Behavioral: EA + Resistance Training (RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in NAFLD score at three and six months
Measured: Six months
Secondary outcomes (2)
Change from Baseline in Indirect calorimetry at three and six months
Measured: Six months
Percentage Change from Baseline in Bioimpedenziometry at three and six months
Percentage reduction in Fat Mass; Percentage increase in Muscle mass
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto R Osella, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Investigators
- Alberto R Osella, MD, PhD, Principal investigator, IRRCS "Saverio De Bellis", Via Turi 27, 70013, Castellana Grotte (Bari), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367742
- Sponsor's protocol ID
- NUTRIEPATT
- Status last verified
- Feb 2015
- First submitted
- 13 Feb 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Programs of Physical Activity on the Grade of Severity of NAFLD
- ClinicalTrials.gov ID
- NCT02367742
- Acronym / sponsor ID
- NUTRIEPATT
- Conditions
- NAFLD
- Keywords
- Diet, Physical Activity, NAFLD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endurance Activity (EA) | Other | Behavioral: Endurance Activity (EA)The subjects have followed a program of endurance (aerobic) activity (EA). |
| EA + Resistance Training (RT) | Other | Behavioral: EA + Resistance Training (RT)The subjects have followed a program of endurance activity (EA) and resistance training (RT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate or severe NAFLD
- Enrolled in the previous trial called NUTRIEP
Key exclusion criteria (1 listed)
- Not enrolled in the previous trial called NUTRIEP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurance Activity (EA)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%. | Behavioural | Endurance Activity (EA) |
| EA + Resistance Training (RT)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%. | Behavioural | EA + Resistance Training (RT) |
Primary outcome
Change from Baseline in NAFLD score at three and six months
Time frame: Six months
2 secondary outcomes
Change from Baseline in Indirect calorimetry at three and six months
Time frame: Six months
Percentage Change from Baseline in Bioimpedenziometry at three and six months
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto R Osella, MD, PhD principal investigator
IRRCS "Saverio De Bellis", Via Turi 27, 70013, Castellana Grotte (Bari), Italy
Questions about this trial
What is this clinical trial studying?
A study testing Endurance Activity (EA) and EA + Resistance Training (RT) in people with NAFLD, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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 from Baseline in NAFLD score at three and six months (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2015.