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

Samsung Medical Center

Status: Terminated

Conditions: Insulin Resistance; Hepatocellular Carcinoma

Treatments: Behavioral: Mobile health

Study type: Interventional

Funder types: Other

Identifiers

NCT04649671

SMC2020-06-037

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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%)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Standard care

No Intervention group

Description:

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.

Mobile health

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mobile health