NCT04649671TerminatedNot Applicable
The Effect of Mobile Health-based Exercise on Insulin Sensitivity in Hepatocellular Carcinoma Patients With Insulin Resistance: A Randomized Controlled Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Samsung Medical Center
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Improvement of insulin resistance
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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%)
Outcomes
Primary Outcomes
Improvement of insulin resistance
Time Frame: After 12 weeks
The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (\<2.2)
Secondary Outcomes
- Improvement of 6-minute walk test(After 12 and 24 weeks)
- Improvement of grip strength test(After 12 and 24 weeks)
- Improvement of 30-second chair stand test(After 12 and 24 weeks)
- Improvement of the score of International Physical Activity Questionnaire-Short Form (IPAQ-SF)(After 12 and 24 weeks)
- Improvement of quality of life(After 12 and 24 weeks)
- Improvement of insulin resistance(After 24 weeks)
- Nutritional status(After 12 and 24 weeks)
- Adverse events(After 12 and 24 weeks)
Investigators
Moon Seok Choi
Professor
Samsung Medical Center
Study Sites (2)
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