The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial
Abstract Background The importance of insulin resistance is gaining increasing attention as it plays an important role in carcinogenesis in hepatocellular carcinoma (HCC). Although exercise is the most important intervention for lowering insulin resistance, it is not easy for HCC patients to maintai...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-11-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06858-w |
| _version_ | 1797988402032803840 |
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| author | Seung Mi Yeo Joo Hyun Oh Hee Ju Yu Dong Hyun Sinn Ji Hye Hwang |
| author_facet | Seung Mi Yeo Joo Hyun Oh Hee Ju Yu Dong Hyun Sinn Ji Hye Hwang |
| author_sort | Seung Mi Yeo |
| collection | DOAJ |
| description | Abstract Background The importance of insulin resistance is gaining increasing attention as it plays an important role in carcinogenesis in hepatocellular carcinoma (HCC). Although exercise is the most important intervention for lowering insulin resistance, it is not easy for HCC patients to maintain high compliance and do appropriate exercise. Mobile health (mHealth) with wearable devices can be the solution to carry out an adjusted and supervised exercise that can normalize insulin resistance in patients with HCC. We developed an HCC-specific application equipped with patient-centered exercise. In this paper, we present a randomized controlled trial protocol comparing an intervention group with a control group to determine whether mHealth-based exercise is effective in normalizing insulin sensitivity in HCC patients with insulin resistance after anticancer treatment. Methods An assessor unblinded open label randomized controlled trial (RCT) will be conducted for 80 participants with treatment-naïve or recurrent HCC who have received treatment and achieved complete response at the time of screening. They will be randomly assigned (1:1) to one of two groups: an intervention group (n = 40) and a control group (n = 40). The intervention group will carry out mHealth-based exercise for 6 months from baseline, whereas the control group will receive the usual follow-up care for the first 3 months and mHealth-based exercise for the next 3 months. Both groups will be assessed at baseline, 3 months, and 6 months from baseline. The primary outcome is the normalized rate of insulin resistance in each group at 3 months. Insulin resistance is estimated by calculating homeostatic model assessment for insulin resistance (HOMA-IR). The secondary outcomes are body composition, physical fitness level, physical activity, and quality of life at 3 months. Discussion This study is the first RCT to investigate the effect of mHealth-based home exercise with a wrist-wearable device on insulin sensitivity, physical fitness, and quality of life for HCC patients with insulin resistance. The result of this RCT will confirm not only safety and functional improvement but also biological effect when exercising using mHealth in HCC patients. Trial registration ClinicalTrials.gov NCT04649671 . Registered on 2 December 2020. The World Health Organization Trial Registration Data Set is not registered. |
| first_indexed | 2024-04-11T08:02:35Z |
| format | Article |
| id | doaj.art-4dcbbfddd0a749b88db38e31b0ea6b54 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T08:02:35Z |
| publishDate | 2022-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-4dcbbfddd0a749b88db38e31b0ea6b542022-12-22T04:35:39ZengBMCTrials1745-62152022-11-0123111010.1186/s13063-022-06858-wThe effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trialSeung Mi Yeo0Joo Hyun Oh1Hee Ju Yu2Dong Hyun Sinn3Ji Hye Hwang4Department of Rehabilitation Medicine, Pusan National University Yangsan Hospital, Pusan National University School of MedicineDepartment of Medicine, Nowon Eulji Medical Center, Eulji University School of MedicineDepartment of Physical Therapy, Graduate School, Sahmyook UniversityDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of MedicineDepartment of Physical and Rehabilitation Medicine, Samsung Medical Center, Sungkyunkwan University School of MedicineAbstract Background The importance of insulin resistance is gaining increasing attention as it plays an important role in carcinogenesis in hepatocellular carcinoma (HCC). Although exercise is the most important intervention for lowering insulin resistance, it is not easy for HCC patients to maintain high compliance and do appropriate exercise. Mobile health (mHealth) with wearable devices can be the solution to carry out an adjusted and supervised exercise that can normalize insulin resistance in patients with HCC. We developed an HCC-specific application equipped with patient-centered exercise. In this paper, we present a randomized controlled trial protocol comparing an intervention group with a control group to determine whether mHealth-based exercise is effective in normalizing insulin sensitivity in HCC patients with insulin resistance after anticancer treatment. Methods An assessor unblinded open label randomized controlled trial (RCT) will be conducted for 80 participants with treatment-naïve or recurrent HCC who have received treatment and achieved complete response at the time of screening. They will be randomly assigned (1:1) to one of two groups: an intervention group (n = 40) and a control group (n = 40). The intervention group will carry out mHealth-based exercise for 6 months from baseline, whereas the control group will receive the usual follow-up care for the first 3 months and mHealth-based exercise for the next 3 months. Both groups will be assessed at baseline, 3 months, and 6 months from baseline. The primary outcome is the normalized rate of insulin resistance in each group at 3 months. Insulin resistance is estimated by calculating homeostatic model assessment for insulin resistance (HOMA-IR). The secondary outcomes are body composition, physical fitness level, physical activity, and quality of life at 3 months. Discussion This study is the first RCT to investigate the effect of mHealth-based home exercise with a wrist-wearable device on insulin sensitivity, physical fitness, and quality of life for HCC patients with insulin resistance. The result of this RCT will confirm not only safety and functional improvement but also biological effect when exercising using mHealth in HCC patients. Trial registration ClinicalTrials.gov NCT04649671 . Registered on 2 December 2020. The World Health Organization Trial Registration Data Set is not registered.https://doi.org/10.1186/s13063-022-06858-wHepatocellular carcinomamHealthInsulin resistanceExercise in cancer |
| spellingShingle | Seung Mi Yeo Joo Hyun Oh Hee Ju Yu Dong Hyun Sinn Ji Hye Hwang 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 Hepatocellular carcinoma mHealth Insulin resistance Exercise in cancer |
| title | The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial |
| title_full | The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial |
| title_fullStr | The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial |
| title_full_unstemmed | The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial |
| title_short | The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial |
| title_sort | effect of mhealth based exercise on insulin sensitivity for patients with hepatocellular carcinoma and insulin resistance mish protocol of a randomized controlled trial |
| topic | Hepatocellular carcinoma mHealth Insulin resistance Exercise in cancer |
| url | https://doi.org/10.1186/s13063-022-06858-w |
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