The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial

Seung Mi Yeo, Joo Hyun Oh, Hee Ju Yu, Dong Hyun Sinn, Ji Hye Hwang, Seung Mi Yeo, Joo Hyun Oh, Hee Ju Yu, Dong Hyun Sinn, Ji Hye Hwang

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.

Keywords: Exercise in cancer; Hepatocellular carcinoma; Insulin resistance; mHealth.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Participant flow through the randomized controlled trial. RFA, radiofrequency ablation; HOMA-IR, homeostatic model assessment for insulin resistance; 6 MWT, 6-min walk test; IPAQ-SF, Korean version international physical activity questionnaire-short form; EORTC-QOL-C30, European organization for research and treatment of cancer quality of life questionnaire C30; MNA, Mini nutritional assessment
Fig. 2
Fig. 2
Application screenshots. Screenshots of the main page (a), menu tab (b), exercise management [aerobic exercise (c) and resistance exercise (d)], diet management (e), and medication management (f)

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