The Effect of Mobile Health-based Exercise on Insulin Sensitivity in Hepatocellular Carcinoma Patients With Insulin Resistance: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Improvement of insulin resistance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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%)
研究组 & 干预措施
Standard care
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
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.
干预措施: Mobile health (Behavioral)
结局指标
主要结局
Improvement of insulin resistance
时间窗: After 12 weeks
The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (\<2.2)
次要结局
- 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)
- Improvement of quality of life(After 12 and 24 weeks)
- Improvement of insulin resistance(After 24 weeks)
- Nutritional status(After 12 and 24 weeks)
- Adverse events(After 12 and 24 weeks)
研究者
Moon Seok Choi
Professor
Samsung Medical Center