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临床试验/NCT03450200
NCT03450200已完成不适用

Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy

Okayama University1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2017年6月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
121
试验地点
1
主要终点
Change in signs of DPN after intervention, at follow-up

研究概览

简要总结

Diabetic Peripheral Neuropathy (DPN) is the common complication seen in the diabetic patients. Moreover, it will lead to another complication as disabilities and difficulties in activities of daily living (ADL). Most of the intervention for diabetes and diabetic neuropathic patients are mostly focusing on the prevention of foot ulcer. Diabetic foot care can prevent only for diabetes-related foot ulcer and foot amputation. It cannot be reduced DPN and cannot be improved the activities of daily living of the patient with DPN. Moreover, there is the restriction of weight-bearing exercise on the recommendation of exercises for the patients with DPN. Therefore, exercise program which may be suitable for all the patients with DPN was introduced in this study to improve ADL and decrease the neuropathic symptoms in the diabetic patients.

Compliance with exercise or intervention is not only critical to get adherence but also for the long-term use of its. Easy to do exercise in the short duration which can able to do on their own in their home promote their compliance and adherence to the exercises. In this study, the effectiveness of exercises in the patients with diabetic peripheral neuropathy was examined to fulfill the requirement of exercises which is simple and can be done in a short time. The objective of the study is to examine the effectiveness of exercise in the patients with diabetic peripheral neuropathy.

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
None

入排标准

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

入选标准

  • •The patients receiving diabetic care at the out-patient-department of designated hospitals, able to contact via the telephone, presence of signs and symptoms of DPN, agreed to involve in the study (informed consent), and aged over 25 years

排除标准

  • •The persons who are suffering from DPN other than diabetes, severe illness of diabetic patients, diabetes with other comorbidities, amputation of hands and feet from any reasons, mental illness and alcoholism

研究组 & 干预措施

Exercises Group

Experimental

three times daily exercises of hands and fingers exercises and foot exercises which last for 10 minutes in eight weeks, and health education about diabetic foot care

干预措施: exercises for diabetic peripheral neuropathy (Other)

Exercises Group

Experimental

three times daily exercises of hands and fingers exercises and foot exercises which last for 10 minutes in eight weeks, and health education about diabetic foot care

干预措施: Health education for diabetic foot care (Other)

Control Group

Other

health education about diabetic foot care

干预措施: Health education for diabetic foot care (Other)

结局指标

主要结局

Change in signs of DPN after intervention, at follow-up

时间窗: eight weeks after intervention, eight weeks follow-up

DPN was assessed by using monofilament (SMW), Touch-TestTM Sensory Evaluator 5 Pieces Hand Kit of North Coast Medical Inc.

Change in Activities of daily living (ADLs) after intervention, at follow-up

时间窗: eight weeks after intervention, eight weeks follow-up

ADLs were measured by using Patient Neurotoxicity Questionnaire (PNQ).

次要结局

  • Change in strength of pinch force(eight weeks after intervention, eight weeks follow-up)
  • Change in walking speed(eight weeks after intervention, eight weeks follow-up)
  • Change in strength of hand grip(eight weeks after intervention, eight weeks follow-up)

研究者

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

Mi Mi Thet Mon Win

Graduate Student

Okayama University

研究点 (1)

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