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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Insulins | Study protocol

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

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

Published in: Trials | Issue 1/2022

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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.
Appendix
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Literature
1.
Patel AV, Friedenreich CM, Moore SC, Hayes SC, Silver JK, Campbell KL, et al. American College of Sports Medicine roundtable report on physical activity, sedentary behavior, and cancer prevention and control. Med Sci Sports Exerc. 2019;51(11):2391–402.CrossRefPubMedPubMedCentral
2.
Schmitz KH, Campbell AM, Stuiver MM, Pinto BM, Schwartz AL, Morris GS, et al. Exercise is medicine in oncology: Engaging clinicians to help patients move through cancer. CA Cancer J Clin. 2019;69(6):468–84.CrossRefPubMedPubMedCentral
3.
Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, et al. Exercise guidelines for cancer survivors: consensus statement from international multidisciplinary roundtable. Med Sci Sports Exerc. 2019;51(11):2375–90.CrossRefPubMedPubMedCentral
4.
Global Burden of Disease Liver Cancer Collaboration, Akinyemiju T, Abera S, Ahmed M, Alam N, Alemayohu MA, et al. The burden of primary liver cancer and underlying etiologies from 1990 to 2015 at the global, regional, and national level: results from the Global Burden of Disease Study 2015. JAMA Oncol. 2017;3(12):1683–91.CrossRefPubMedCentral
5.
Perumpail BJ, Khan MA, Yoo ER, Cholankeril G, Kim D, Ahmed A. Clinical epidemiology and disease burden of nonalcoholic fatty liver disease. World J Gastroenterol. 2017;23(47):8263–76.CrossRefPubMedPubMedCentral
6.
Shi T, Kobara H, Oura K, Masaki T. Mechanisms Underlying Hepatocellular Carcinoma Progression in Patients with Type 2 Diabetes. J Hepatocell Carcinoma. 2021;8:45–55.CrossRefPubMedPubMedCentral
7.
Kim JH, Sinn DH, Gwak GY, Kang W, Paik YH, Choi MS, et al. Insulin resistance and the risk of hepatocellular carcinoma in chronic hepatitis B patients. J Gastroenterol Hepatol. 2017;32(5):1100–6.CrossRefPubMed
8.
Imai K, Takai K, Hanai T, Suetsugu A, Shiraki M, Shimizu M. Homeostatic model assessment of insulin resistance for predicting the recurrence of hepatocellular carcinoma after curative treatment. Int J Mol Sci. 2019;20(3):605.
9.
Sampath Kumar A, Maiya AG, Shastry BA, Vaishali K, Ravishankar N, Hazari A, et al. Exercise and insulin resistance in type 2 diabetes mellitus: a systematic review and meta-analysis. Ann Phys Rehabil Med. 2019;62(2):98–103.CrossRefPubMed
10.
Piguet AC, Saran U, Simillion C, Keller I, Terracciano L, Reeves HL, et al. Regular exercise decreases liver tumors development in hepatocyte-specific PTEN-deficient mice independently of steatosis. J Hepatol. 2015;62(6):1296–303.CrossRefPubMed
11.
Saran U, Guarino M, Rodríguez S, Simillion C, Montani M, Foti M, et al. Anti-tumoral effects of exercise on hepatocellular carcinoma growth. Hepatology Commun. 2018;2(5):607–20.CrossRef
12.
Baumeister SE, Schlesinger S, Aleksandrova K, Jochem C, Jenab M, Gunter MJ, et al. Association between physical activity and risk of hepatobiliary cancers: a multinational cohort study. J Hepatol. 2019;70(5):885–92.CrossRefPubMed
13.
García-Pagàn JC, Santos C, Barberá JA, Luca A, Roca J, Rodriguez-Roisin R, et al. Physical exercise increases portal pressure in patients with cirrhosis and portal hypertension. Gastroenterology. 1996;111(5):1300–6.CrossRefPubMed
14.
Kaibori M, Ishizaki M, Matsui K, Nakatake R, Yoshiuchi S, Kimura Y, et al. Perioperative exercise for chronic liver injury patients with hepatocellular carcinoma undergoing hepatectomy. Am J Surg. 2013;206(2):202–9.CrossRefPubMed
15.
Kaibori M, Matsui K, Yoshii K, Ishizaki M, Iwasaka J, Miyauchi T, et al. Perioperative exercise capacity in chronic liver injury patients with hepatocellular carcinoma undergoing hepatectomy. PLoS ONE. 2019;14(8):e0221079.CrossRefPubMedPubMedCentral
16.
Tsuchihashi J, Koya S, Hirota K, Koga N, Narao H, Tomita M, et al. Effects of In-Hospital Exercise on Frailty in Patients with Hepatocellular Carcinoma. Cancers (Basel). 2021;13(2):194.
17.
Monteiro-Guerra F, Signorelli GR, Rivera-Romero O, Dorronzoro-Zubiete E, Caulfield B. Breast cancer survivors’ perspectives on motivational and personalization strategies in mobile app-based physical activity coaching interventions: qualitative study. JMIR Mhealth Uhealth. 2020;8(9): e18867.CrossRefPubMedPubMedCentral
18.
Nabi J, Cone EB, Vasavada A, Sun M, Kilbridge KL, Kibel AS, et al. Mobile health app for prostate cancer patients on androgen deprivation therapy: qualitative usability study. JMIR Mhealth Uhealth. 2020;8(11):e20224.CrossRefPubMedPubMedCentral
19.
Kim Y, Seo J, An SY, Sinn DH, Hwang JH. Efficacy and safety of an mHealth app and wearable device in physical performance for patients with hepatocellular carcinoma: development and usability study. JMIR Mhealth Uhealth. 2020;8(3):e14435.CrossRefPubMedPubMedCentral
20.
Thompson PD, Arena R, Riebe D, Pescatello LS. ACSM’s new preparticipation health screening recommendations from ACSM’s guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013;12(4):215–7.CrossRefPubMed
21.
Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998;158(5 Pt 1):1384–7.CrossRefPubMed
22.
Magkos F, Tsekouras Y, Kavouras SA, Mittendorfer B, Sidossis LS. Improved insulin sensitivity after a single bout of exercise is curvilinearly related to exercise energy expenditure. Clin Sci. 2008;114(1):59–64.CrossRef
23.
24.
Harrison SA. Liver disease in patients with diabetes mellitus. J Clin Gastroenterol. 2006;40(1):68–76.CrossRefPubMed
25.
Tanaka S, Wands JR. Insulin receptor substrate 1 overexpression in human hepatocellular carcinoma cells prevents transforming growth factor β1-induced apoptosis. Can Res. 1996;56(15):3391–4.
26.
Saran U, Humar B, Kolly P, Dufour J-F. Hepatocellular carcinoma and lifestyles. J Hepatol. 2016;64(1):203–14.CrossRefPubMed
27.
Behrens G, Matthews CE, Moore SC, Freedman ND, McGlynn KA, Everhart JE, et al. The association between frequency of vigorous physical activity and hepatobiliary cancers in the NIH-AARP Diet and Health Study. Eur J Epidemiol. 2013;28(1):55–66.CrossRefPubMedPubMedCentral
Metadata
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
Authors
Seung Mi Yeo
Joo Hyun Oh
Hee Ju Yu
Dong Hyun Sinn
Ji Hye Hwang
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06858-w

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