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临床试验/NCT03766802
NCT03766802Unknown不适用

Effects of Wearable Technology and Smart Mobile Phone Applications Based Exercise Training and Supervised Exercise Training in Patients With Type 2 Diabetes

Marmara University2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2018年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
102
试验地点
2
主要终点
Glycated Hemoglobin (HbA1c)

研究概览

简要总结

The purpose of this study is to estimate the extent to which supported exercise training through wearable technology and mobile application affects glycemic control in comparison to supervised exercise training in patients with Type-2 Diabetes.

详细描述

The purpose of this study is to estimate the extent to which supported exercise training through wearable technology and mobile application affects glycemic control in comparison to supervised exercise training in patients with Type-2 Diabetes.

Inclusion Criteria:

  • Age 18-65
  • No other chronic condition
  • No exercise training background Block Randomization according to age and sex.

Confirmatory Outcome

  • Glycated Hemoglobin (HbA1c)

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 No other chronic condition No exercise training background

排除标准

  • Exclusion criteria are a set of predefined condition that is used to identify subjects who will not be included or who will have to withdraw from a research study after being included.

研究组 & 干预措施

Wearable watch training group.

Active Comparator

Aerobic exercises Strengthening exercises Stretching exercises Balance exercises Dose was increased as person is able to tolerate. Form:intervention is trackable and notifiable if patients don't exercise with smartwatch.

Frequency:3/week Duration:12 weeks Dosage:Dose was increased as person is able to tolerate.

干预措施: Wearable watch training group. (Behavioral)

Mobile application training group.

Active Comparator

Aerobic exercises Strengthening exercises Stretching exercises

Balance exercises Form:intervention is trackable and notifiable if patients don't exercise with smartphone Dose was increased as person is able to tolerate. Frequency:3/week Duration:12 weeks Dosage:Dose was increased as person is able to tolerate.

干预措施: Mobile application training group. (Behavioral)

Supervised exercise training group

Sham Comparator

Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist

干预措施: Supervised exercise training group (Behavioral)

结局指标

主要结局

Glycated Hemoglobin (HbA1c)

时间窗: 5 minutes

It used as a diagnostic test for diabetes and as assessment test for glycemic control in people with diabetes. It comes in unit of percentage identifies how much glucose is carried on a certain amount of blood. We included people who have 6.5% or more which is the cut point for The International Diabetes Federation and the American College of Endocrinology.

次要结局

  • Six-Minute Walk Test(6 min)
  • International physical activity questionnaire short form (IPAQ)(7 days)
  • The forced vital capacity(10 minutes)
  • Forced expiratory volume(10 minutes)
  • Assessment of muscle strength with isokinetic device(15 minutes)
  • Accelerometer(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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