Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy

Not Applicable

Completed

• Conditions: Diabetic Peripheral Neuropathy

• Registration Number: NCT03450200
• Lead Sponsor: Okayama University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-17
• Primary Completion: 2017-10-16
• Study Completion: 2017-10-16
• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-03-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-08
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Activities of daily living (ADLs) after intervention, at follow-up	eight weeks after intervention, eight weeks follow-up	ADLs were measured by using Patient Neurotoxicity Questionnaire (PNQ).
Change in signs of DPN after intervention, at follow-up	eight weeks after intervention, eight weeks follow-up	DPN was assessed by tuning fork vibration test.

Secondary Outcome Measures

Name	Time	Method
Change in strength of pinch force	eight weeks after intervention, eight weeks follow-up	Key (lateral pinch) was measured by the gold standard B\&L Engineering® Pinch Gauge 0-30 lb. in 1.0 lb.
Change in walking speed	eight weeks after intervention, eight weeks follow-up	Timed Up and Go (TUG) test was to measure the duration for walking in seconds.
Change in strength of hand grip	eight weeks after intervention, eight weeks follow-up	Hand grip was measured in kilograms by using TTM original Dynamometer 100 kg.

Trial Locations

Locations (1)

Okayama University; 🇯🇵 Okayama, Japan