Clinical trial NCT03450200: Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy
Official title: Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: Diabetic Peripheral Neuropathy, Exercises
Lead sponsor: Okayama University
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 121
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Activities of daily living (ADLs) after intervention, at follow-up
timeFrame: eight weeks after intervention, eight weeks follow-up
measure: Change in signs of DPN after intervention, at follow-up
timeFrame: eight weeks after intervention, eight weeks follow-up
measure: Change in signs of DPN after intervention, at follow-up
timeFrame: eight weeks after intervention, eight weeks follow-up
Secondary outcomes:
measure: Change in strength of hand grip
timeFrame: eight weeks after intervention, eight weeks follow-up
measure: Change in strength of pinch force
timeFrame: eight weeks after intervention, eight weeks follow-up
measure: Change in walking speed
timeFrame: eight weeks after intervention, eight weeks follow-up
Other outcomes:
Locations:
city: Okayama
country: Japan
facility: Okayama University
Study officials:
affiliation: Graduate School of Health Sciences, Okayama University
name: Mi Mi Thet Mon Win, PhD student
role: PRINCIPAL_INVESTIGATOR
References: