Clinical trial NCT04649671: The Effect of Mobile Health-based Exercise on Hepatocellular Carcinoma Patients With Insulin Resistance
Official title: The Effect of Mobile Health-based Exercise on Insulin Sensitivity in Hepatocellular Carcinoma Patients With Insulin Resistance: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatocellular Carcinoma
Insulin Resistance
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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%)

Primary outcomes:
measure: Improvement of insulin resistance
timeFrame: After 12 weeks
Secondary outcomes:
measure: Improvement of insulin resistance
timeFrame: After 24 weeks
measure: Improvement of 6-minute walk test
timeFrame: After 12 and 24 weeks
measure: Improvement of grip strength test
timeFrame: After 12 and 24 weeks
measure: Improvement of 30-second chair stand test
timeFrame: After 12 and 24 weeks
measure: Improvement of the score of International Physical Activity Questionnaire-Short Form (IPAQ-SF)
timeFrame: After 12 and 24 weeks
measure: Improvement of quality of life
timeFrame: After 12 and 24 weeks
measure: Nutritional status
timeFrame: After 12 and 24 weeks
measure: Adverse events
timeFrame: After 12 and 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Moon Seok Choi
Study officials:
References:
citation: 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.