NCT05265026

Brief Summary

This study is a randomised, controlled, unblinded, clinical intervention trial consisting of 12 weeks of aerobic exercise training. Thirty persons with chronic hepatitis B (CHB) and hepatic steatosis are randomised to either aerobic exercise training (intervention group, n=15) or no intervention (control group, n=15). The study will investigate the effects of the exercise intervention on the liver and the hypothesis is that the exercise group will reduce the fat-fraction of the liver after the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

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

February 11, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

February 11, 2022

Last Update Submit

October 26, 2023

Conditions

Hepatitis B, ChronicHepatic Steatosis

Outcome Measures

Primary Outcomes (1)

  • Fat-Fraction of the Liver

    Hepatic fat-fraction measured by MRI with IDEAL-IQ (%)

    From baseline to follow-up at 12 weeks

Secondary Outcomes (31)

  • Fibroblast growth factor 21 (FGF21) secretion

    From baseline to follow-up at 12 weeks

  • Follistatin secretion

    From baseline to follow-up at 12 weeks

  • Growth/differentiation factor 15 (GDF15) secretion

    From baseline to follow-up at 12 weeks

  • Angiopoietin-like 4 (ANGPTL4) secretion

    From baseline to follow-up at 12 weeks

  • C-reactive protein (CRP) secretion

    From baseline to follow-up at 12 weeks

  • +26 more secondary outcomes

Study Arms (2)

Exercise Intervention Arm

EXPERIMENTAL

Three high intensity interval exercise sessions per week of 40 minutes duration per session. Exercise will be performed on ergometerbikes.

Behavioral: High Intensity Interval Training

No Intervention

NO INTERVENTION

No lifestyle changes

Interventions

High Intensity Interval TrainingBEHAVIORAL

A training session consists of 40 minutes as follows: 4x4 minutes at \> 85% of heart rate maximum (HRmax) alternated by 3x3 minutes active recovery at (50-70% of HRmax) and a 10-min-warm-up (60-79% of HRmax) and 5- minute cool-down at \~ warm up intensity. HRmax was determined during the VO2max test at baseline visit. Minutes spent in the different heart rate zones is monitored during the session (zone 1: 60-69%, zone 2: 70-74%, zone 3: 75-79%, zone 4: 80-84%, zone 5: \>85% of HRmax).

Exercise Intervention Arm

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic hepatitis B defined by HBsAg positive \>6 months
  • Positive HBV-DNA
  • Age \>30
  • Hepatic steatosis diagnosed by Controlled Attenuated Parameter (CAP) \>250 assessed by Transient Elastography or by ultrasound defined hepatic steatosis

You may not qualify if:

  • HIV, HCV, HDV-co infection
  • Primary biliary cholangitis
  • Wilsons Disease
  • Autoimmune hepatitis
  • Hepatocellular carcinoma
  • Antiviral medication
  • Steatogenic medication (systemic corticosteroids, amiodarone, tamoxifen, valproic acid, and methotrexate)
  • Average alcohol intake \>30 g for men and \>20 g for women pr. day
  • Contraindications for MRI scan
  • Coronary artery disease contraindicating HIIT
  • Unable to understand and read written information for participants written consent
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Physical Activity Research

Copenhagen, Denmark

Location

Related Publications (1)

  • Jespersen S, Plomgaard P, Madsbad S, Hansen AE, Bandholm T, Pedersen BK, Ritz C, Weis N, Krogh-Madsen R. Effect of aerobic exercise training on the fat fraction of the liver in persons with chronic hepatitis B and hepatic steatosis: Trial protocol for a randomized controlled intervention trial- The FitLiver study. Trials. 2023 Jun 13;24(1):398. doi: 10.1186/s13063-023-07385-y.

    PMID: 37312098DERIVED

MeSH Terms

Conditions

Hepatitis B, ChronicFatty Liver

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD, PhD-student

Study Record Dates

First Submitted

February 11, 2022

First Posted

March 3, 2022

Study Start

March 14, 2022

Primary Completion

September 30, 2023

Study Completion

October 1, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations

DK(1)