Effect of High Intensity Exercise Rehabilitation on Liver Function and Insulin Sensitivity in Patients With MASLD

NCT06359444 | Recruiting

• 1 other identifier: ONZ-2023-0453
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, and is associated with obesity and the metabolic syndrome. Physical activity and lifestyle interventions are among the most recommended treatments for individuals with MASLD. In this RCT, we will evaluate the effect of combined exercise training "strength and aerobic training" versus "strength and high intensity training (HIIT)". The main outcome parameter is the severity of liver steatosis. Patients will be recruited at the fatty liver clinic of the UZ Gent.

Conditions

Exercise Therapy; Metabolic Dysfunction-associated Steatotic Liver Disease

Keywords

exercise; MASLD; liver diseases

Outcome Measures

Primary Outcomes (2)

• Liver steatosis by CAP

  Liver stiffness measurement will be performed using vibration-controlled transient elastography, more specifically the Fibroscan. This method measures the fat accumulation in the liver (dB/m) and the level of scar tissue (kPa), represented as the CAP or steatosis score and the fibrosis score respectively.

  before training and after training (14 weeks)

• Liver steatosis on ultrasound

  Ultrasound can demonstrate hepatic fatty tissue, estimating severity based on liver-kidney contrast, resolution loss thv the intrahepatic blood vessels, and visibility of the diaphragm. On this basis, a score 0-3 can be assigned.

  before training and after training (14 weeks)

Secondary Outcomes (16)

• Insulin sensitivity

  before training and after training (14 weeks)

• Liver transaminases

  before training and after training (14 weeks)

• Maximal exercise test

  before training and after training (14 weeks)

• Strength

  before training and after training (14 weeks)

• Cardiovascular function

  before training and after training (14 weeks)

Study Arms (2)

Combined strength + aerobic training

ACTIVE COMPARATOR

The patients in this group will exercise for 14 weeks. It is a combination of strength and aerobic exercise.

Other: Combined aerobic + strength training

Combined strength + HIIT

EXPERIMENTAL

The patients in this group will exercise for 14 weeks. The first 6 weeks consists of combined aerobic and strength exercise, following the protocol from the active comparator group. They will switch to combined strength and HIIT exercise for the remaining 8 weeks.

Other: Combined strength + HIIT training

Interventions

Combined aerobic + strength training OTHER

Participants will follow a combination of endurance and strength training for 14 weeks. There will be three sessions every week: two at Ghent university department of rehabilitation and one at home. Each session will last approximately one hour.

Combined strength + aerobic training

Combined strength + HIIT training OTHER

6 weeks of endurance training and strength training, 8 weeks of strength training and HIIT. Participants will follow the same combination of endurance and strength training for the first six weeks, to build up to a baseline level of physical fitness. They will then switch to eight weeks of a combination of strength training and High Intensity Interval Training (HIIT). There will be three sessions every week: two at Ghent university department of rehabilitation and one at home. Each session will last approximately one hour.

Combined strength + HIIT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with MASLD by ultrasound, CAP and/or biopsy
• Age between 18 and 75 years old
• No significant liver fibrosis (Fibroscan \< 7.5 kPa; if it is between \>7.5 and \<10, there must be absence of liver fibrosis in the biopsy)

You may not qualify if:

• Presence of other liver diseases that may contribute to the clinical presentation in the patient
• Severe cardiovascular, orthopedic, physical or other illnesses that make it impossible to participate in the study's exercise rehabilitation program or where safety cannot be guaranteed
• Pregnancy
• Pharmacological treatment that directly affects MASLD (e.g. GLP-1 analogues)
• A change in medication in the last three months before the study that affects metabolic disease stability

Sponsors & Collaborators

• University Ghent: lead
• University Hospital, Ghent: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

Related Publications (4)

• Keating SE, Hackett DA, George J, Johnson NA. Exercise and non-alcoholic fatty liver disease: a systematic review and meta-analysis. J Hepatol. 2012 Jul;57(1):157-66. doi: 10.1016/j.jhep.2012.02.023. Epub 2012 Mar 10.

  PMID: 22414768 BACKGROUND

• Hashida R, Kawaguchi T, Bekki M, Omoto M, Matsuse H, Nago T, Takano Y, Ueno T, Koga H, George J, Shiba N, Torimura T. Aerobic vs. resistance exercise in non-alcoholic fatty liver disease: A systematic review. J Hepatol. 2017 Jan;66(1):142-152. doi: 10.1016/j.jhep.2016.08.023. Epub 2016 Sep 14.

  PMID: 27639843 BACKGROUND

• Oh S, Tsujimoto T, Kim B, Uchida F, Suzuki H, Iizumi S, Isobe T, Sakae T, Tanaka K, Shoda J. Weight-loss-independent benefits of exercise on liver steatosis and stiffness in Japanese men with NAFLD. JHEP Rep. 2021 Feb 10;3(3):100253. doi: 10.1016/j.jhepr.2021.100253. eCollection 2021 Jun.

  PMID: 33898958 BACKGROUND

• Karlas T, Petroff D, Sasso M, Fan JG, Mi YQ, de Ledinghen V, Kumar M, Lupsor-Platon M, Han KH, Cardoso AC, Ferraioli G, Chan WK, Wong VW, Myers RP, Chayama K, Friedrich-Rust M, Beaugrand M, Shen F, Hiriart JB, Sarin SK, Badea R, Jung KS, Marcellin P, Filice C, Mahadeva S, Wong GL, Crotty P, Masaki K, Bojunga J, Bedossa P, Keim V, Wiegand J. Individual patient data meta-analysis of controlled attenuation parameter (CAP) technology for assessing steatosis. J Hepatol. 2017 May;66(5):1022-1030. doi: 10.1016/j.jhep.2016.12.022. Epub 2016 Dec 28.

  PMID: 28039099 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Liver Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior; Digestive System Diseases

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

• Patrick Calders, Prof. dr.

  University Ghent

  PRINCIPAL INVESTIGATOR

• Anja Geerts, Prof. dr.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Sander Lefere, dr.

  University Ghent

  STUDY CHAIR

Central Study Contacts

Patrick Calders, Prof. dr.

CONTACT

0032498354766; patrick.calders@ugent.be

Sander Lefere, dr.

CONTACT

sander.lefere@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The training will be given by the care provider, but in exercise therapy it is not possible to mask. The assessor will assess the patients without knowing in which group they will be randomized. Randomization will be done by an external person who is only involved for randomization. The investigator, who will be analysing data afterwords, will only see 1 or 2 as group number, but will not know which number is corresponding to which group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in two groups: (a) combined aerobic and strength and (b) combined high intensity and strength.

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: April 11, 2024
• Study Start: April 26, 2024
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)