Study Stopped
Difficulty in recruitment and deficit of research fund
The Effect of Mobile Health-based Exercise on Hepatocellular Carcinoma Patients With Insulin Resistance
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hepatocellular-carcinoma
Started Mar 2021
Shorter than P25 for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2020
CompletedFirst Posted
Study publicly available on registry
December 2, 2020
CompletedStudy Start
First participant enrolled
March 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2023
CompletedMarch 6, 2023
March 1, 2023
2 years
November 17, 2020
March 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement of insulin resistance
The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (\<2.2)
After 12 weeks
Secondary Outcomes (8)
Improvement of insulin resistance
After 24 weeks
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
- +3 more secondary outcomes
Study Arms (2)
Standard care
NO INTERVENTIONHepatocellular 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.
Mobile health
ACTIVE COMPARATORHCC 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.
Interventions
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
You may qualify if:
- 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)
You may not qualify if:
- 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%)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moon Seok Choi
Seoul, 06351, South Korea
Related Publications (1)
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.
PMID: 36348422DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 17, 2020
First Posted
December 2, 2020
Study Start
March 2, 2021
Primary Completion
March 2, 2023
Study Completion
March 2, 2023
Last Updated
March 6, 2023
Record last verified: 2023-03