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临床试验/NCT03994289
NCT03994289已完成不适用

Effects of Motor-assisted Cycling and Functional Electrical Stimulation Cycling on Postprandial Glucose in Type 2 Diabetic Patients With Activities of Daily Living Disability

Arizona State University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Postprandial glucose AUC

研究概览

简要总结

Exercise has been the cornerstone of diabetes management. However, many diabetic patients have ADL disabilities and experience substantial difficulty in performing usual exercises, such as brisk walking and upright cycling. There is an urgent need to provide alternative exercise modalities for diabetic patients with ADL disabilities. In this study, investigators will investigate the effects on the glucose of three exercise modalities, including motor-assisted cycling (i.e., cycling on a motor-driven bike) and functional electrical stimulation (FES) cycling, during which the investigators will use electrical current to facilitate cycling movements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 60 years.
  • Physician-diagnosed type 2 diabetes.
  • ADL disability (self-reported).

排除标准

  • Fasting glucose ≥ 250 mg/dL.
  • Symptomatic hypoglycemic events in the past three months.
  • Insulin injection or infusion
  • Systolic blood pressure ≥ 160 mmHg OR Diastolic blood pressure ≥ 100 mmHg
  • Diagnosis of NYHA class I-IV heart failure
  • Myocardial infarction in the past 6 months
  • Recent or current angina, shortness of breath, or other symptoms suggestive of heart failure
  • Diagnosed Cancer
  • Unable to consent due to impaired cognitive function
  • Bone fracture, joint dislocation, or joint stiffness
  • Local skin disorders at the FES cuff area or CGM sensor area
  • Implantable electronic or metallic devices, such as cardioverter defibrillator and pacemaker

结局指标

主要结局

Postprandial glucose AUC

时间窗: The glucose will be measured using CGM during the 2-hour postprandial period.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chong Lee

Associate Professor

Arizona State University

研究点 (2)

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