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Difficulty in recruitment and deficit of research fund
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | No Intervention | 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. | |
| Mobile health | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile health | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of insulin resistance | The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2) | After 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of insulin resistance | The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2) | After 24 weeks |
| Improvement of 6-minute walk test | - Changes in meters assessed using the 6-minute walk test |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moon Seok Choi | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36348422 | Derived | 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. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| After 12 and 24 weeks |
| Improvement of grip strength test | - Changes in kilograms assessed using grip strength test | After 12 and 24 weeks |
| Improvement of 30-second chair stand test | - Changes in seconds assessed using 30-second chair stand test | After 12 and 24 weeks |
| 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 |
| 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 |
| Nutritional status | Comparison of nutrition score using mini nutritional assessment | After 12 and 24 weeks |
| Adverse events | Any adverse events occurred during exercise | After 12 and 24 weeks |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |