Effect of Physical Activity on NAFLD

NCT02367742 | Completed DMC

• 1 other identifier: NUTRIEPATT
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

NAFLD

Keywords

Diet; Physical Activity; NAFLD

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in NAFLD score at three and six months

  Six months

Secondary Outcomes (2)

• Change from Baseline in Indirect calorimetry at three and six months

  Six months

• Percentage Change from Baseline in Bioimpedenziometry at three and six months

  Six months

Other Outcomes (12)

• Height

  At baseline

• Change from Baseline in Body Weight at three and six months

  Six months

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

  Six months

Study Arms (2)

Endurance Activity (EA)

OTHER

The subjects have followed a program of endurance (aerobic) activity (EA).

Behavioral: Endurance Activity (EA)

EA + Resistance Training (RT)

OTHER

The subjects have followed a program of endurance activity (EA) and resistance training (RT).

Behavioral: EA + Resistance Training (RT)

Interventions

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%.

Endurance Activity (EA)

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%.

EA + Resistance Training (RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not enrolled in the previous trial called NUTRIEP

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alberto R Osella, MD, PhD

  IRRCS "Saverio De Bellis", Via Turi 27, 70013, Castellana Grotte (Bari), Italy

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 20, 2015
• Study Start: January 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 24, 2015

Record last verified: 2015-02