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

Primary Purpose

Hepatocellular Carcinoma, Insulin Resistance

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mobile health
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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%)

Sites / Locations

  • Moon Seok Choi

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard care

Mobile health

Arm 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.

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.

Outcomes

Primary Outcome Measures

Improvement of insulin resistance
The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2)

Secondary Outcome Measures

Improvement of insulin resistance
The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2)
Improvement of 6-minute walk test
- Changes in meters assessed using the 6-minute walk test
Improvement of grip strength test
- Changes in kilograms assessed using grip strength test
Improvement of 30-second chair stand test
- Changes in seconds assessed using 30-second chair stand test
Improvement of the score of International Physical Activity Questionnaire-Short Form (IPAQ-SF)
- Changes in metabolic equivalents (METs) per week calculated using IPAQ-SF
Improvement of quality of life
Improved score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire C30
Nutritional status
Comparison of nutrition score using mini nutritional assessment
Adverse events
Any adverse events occurred during exercise

Full Information

First Posted
November 17, 2020
Last Updated
March 2, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04649671
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruitment and deficit of research fund
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
March 2, 2023 (Actual)
Study Completion Date
March 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm 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.
Arm Title
Mobile health
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile health
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement of insulin resistance
Description
The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2)
Time Frame
After 12 weeks
Secondary Outcome Measure Information:
Title
Improvement of insulin resistance
Description
The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2)
Time Frame
After 24 weeks
Title
Improvement of 6-minute walk test
Description
- Changes in meters assessed using the 6-minute walk test
Time Frame
After 12 and 24 weeks
Title
Improvement of grip strength test
Description
- Changes in kilograms assessed using grip strength test
Time Frame
After 12 and 24 weeks
Title
Improvement of 30-second chair stand test
Description
- Changes in seconds assessed using 30-second chair stand test
Time Frame
After 12 and 24 weeks
Title
Improvement of the score of International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Description
- Changes in metabolic equivalents (METs) per week calculated using IPAQ-SF
Time Frame
After 12 and 24 weeks
Title
Improvement of quality of life
Description
Improved score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire C30
Time Frame
After 12 and 24 weeks
Title
Nutritional status
Description
Comparison of nutrition score using mini nutritional assessment
Time Frame
After 12 and 24 weeks
Title
Adverse events
Description
Any adverse events occurred during exercise
Time Frame
After 12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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%)
Facility Information:
Facility Name
Moon Seok Choi
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
36348422
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.
Results Reference
derived

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

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