The Effect of Mobile Health-based Exercise on Hepatocellular Carcinoma Patients With Insulin Resistance
NCT ID: NCT04649671
Last Updated: 2023-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
15 participants
INTERVENTIONAL
2021-03-02
2023-03-02
Brief Summary
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We designed this study to investigate whether personalized exercise with mobile health program improves insulin resistance without decompensation in HCC patients with insulin resistance.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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%)
20 Years
70 Years
ALL
Yes
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Moon Seok Choi
Professor
Locations
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Moon Seok Choi
Seoul, , South Korea
Countries
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References
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Yeo SM, Oh JH, Yu HJ, Sinn DH, Hwang JH. The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial. Trials. 2022 Nov 8;23(1):930. doi: 10.1186/s13063-022-06858-w.
Other Identifiers
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SMC2020-06-037
Identifier Type: -
Identifier Source: org_study_id
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