The Effect of Mobile Health-based Exercise on Hepatocellular Carcinoma Patients With Insulin Resistance

March 2, 2023 updated by: Moon Seok Choi, Samsung Medical Center

The Effect of Mobile Health-based Exercise on Insulin Sensitivity in Hepatocellular Carcinoma Patients With Insulin Resistance: A Randomized Controlled Trial

Exercise is predicted to have positive effect among patients with hepatocellular carcinoma (HCC). However, little attention has been paid to the role of physical activity with wearable device in the management of HCC patients in the aspect of improvement in insulin resistance.

We designed this study to investigate whether personalized exercise with mobile health program improves insulin resistance without decompensation in HCC patients with insulin resistance.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 20 to 70 years
  • Patients who were diagnosed with early-stage HCC, defined by modified UICC stage 1 or 2
  • Patients with treatment-naive and recurrent HCC who have received treatment and achieved complete response at the time of screening
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Patients with insulin resistance (HOMA-IR >=2.2)

Exclusion Criteria:

  • Child Pugh class B or C
  • Alcohol intake >20g/day
  • History of decompensation
  • Severe medical comorbidities (ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure > 200/120 mmHg) or psychiatric illnesses which limit ability to exercise safely
  • Who takes insulin sensitizer (sulfonylurea, biguanide, thiazolidinedione, glucagon-like peptide-1 agonist, dipeptidyl peptidase-4 inhibitor) or uses insulin
  • Uncontrolled diabetes mellitus (Hemoglobin A1c >10%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard care
Hepatocellular carcinoma (HCC) patients with insulin resistance who underwent hepatic resection or radiofrequency ablation (RFA) will be enrolled. Patients included in the control arm will receive a booklet including information about physical activity recommendations and practice (education). After 12 weeks, they will also be provided mobile application and wearable device and perform exercise for 12 weeks.
Active Comparator: Mobile health
HCC patients with insulin resistance who underwent hepatic resection or RFA will be enrolled. Patients included in the intervention arm will receive both booklet and mobile health program. They will perform exercise daily with mobile application and wearable device (warm-up, stretching, aerobic, and strengthening) for 24 weeks.
Behavioral: Mobile health

Perform exercise daily with mobile application and wearable device (warm-up, stretching, aerobic, and strengthening).

Mobile application: Hepatocellular carcinoma by Second Doctor Wearable device: Dofit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of insulin resistance
Time Frame: After 12 weeks
The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2)
After 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of insulin resistance
Time Frame: After 24 weeks
The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2)
After 24 weeks
Improvement of 6-minute walk test
Time Frame: After 12 and 24 weeks
- Changes in meters assessed using the 6-minute walk test
After 12 and 24 weeks
Improvement of grip strength test
Time Frame: After 12 and 24 weeks
- Changes in kilograms assessed using grip strength test
After 12 and 24 weeks
Improvement of 30-second chair stand test
Time Frame: After 12 and 24 weeks
- Changes in seconds assessed using 30-second chair stand test
After 12 and 24 weeks
Improvement of the score of International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time Frame: After 12 and 24 weeks
- Changes in metabolic equivalents (METs) per week calculated using IPAQ-SF
After 12 and 24 weeks
Improvement of quality of life
Time Frame: After 12 and 24 weeks
Improved score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire C30
After 12 and 24 weeks
Nutritional status
Time Frame: After 12 and 24 weeks
Comparison of nutrition score using mini nutritional assessment
After 12 and 24 weeks
Adverse events
Time Frame: After 12 and 24 weeks
Any adverse events occurred during exercise
After 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Actual)

March 2, 2023

Study Completion (Actual)

March 2, 2023

Study Registration Dates

First Submitted

November 17, 2020

First Submitted That Met QC Criteria

November 28, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC2020-06-037

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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