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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatocellular Carcinoma, Insulin Resistance

Intervention / Treatment
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* Behavioral: Mobile health


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>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<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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