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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04649671
• Other study ID #: SMC2020-06-037
• Status: Terminated
• Phase: N/A
• Start date: March 2, 2021
• Est. completion date: March 2, 2023

Study information

• Verified date: March 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 2, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Insulin Resistance

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Moon Seok Choi	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of insulin resistance	The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2)	After 12 weeks
Secondary	Improvement of insulin resistance	The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2)	After 24 weeks
Secondary	Improvement of 6-minute walk test	- Changes in meters assessed using the 6-minute walk test	After 12 and 24 weeks
Secondary	Improvement of grip strength test	- Changes in kilograms assessed using grip strength test	After 12 and 24 weeks
Secondary	Improvement of 30-second chair stand test	- Changes in seconds assessed using 30-second chair stand test	After 12 and 24 weeks
Secondary	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
Secondary	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
Secondary	Nutritional status	Comparison of nutrition score using mini nutritional assessment	After 12 and 24 weeks
Secondary	Adverse events	Any adverse events occurred during exercise	After 12 and 24 weeks