Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450200
• Other study ID #: D16-07
• Secondary ID: Ethics/DMR/2017/
• Status: Completed
• Phase: N/A
• Start date: June 17, 2017
• Est. completion date: October 16, 2017

Study information

• Verified date: May 2019
• Source: Okayama University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 16, 2017
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• exercises for diabetic peripheral neuropathy
Hands, fingers, and foot exercises for diabetic peripheral neuropathy to improve activities of daily living, and decreases the signs and symptoms of DPN
• Health education for diabetic foot care
Health education for daily diabetic foot care to prevent diabetic foot ulcer was provided.

Locations

Country	Name	City	State
Japan	Okayama University	Okayama

Sponsors (1)

Lead Sponsor	Collaborator
Okayama University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Activities of daily living (ADLs) after intervention, at follow-up	ADLs were measured by using Patient Neurotoxicity Questionnaire (PNQ).	eight weeks after intervention, eight weeks follow-up
Primary	Change in signs of DPN after intervention, at follow-up	DPN was assessed by using monofilament (SMW), Touch-TestTM Sensory Evaluator 5 Pieces Hand Kit of North Coast Medical Inc.	eight weeks after intervention, eight weeks follow-up
Primary	Change in signs of DPN after intervention, at follow-up	DPN was assessed by tuning fork vibration test.	eight weeks after intervention, eight weeks follow-up
Secondary	Change in strength of hand grip	Hand grip was measured in kilograms by using TTM original Dynamometer 100 kg.	eight weeks after intervention, eight weeks follow-up
Secondary	Change in strength of pinch force	Key (lateral pinch) was measured by the gold standard B&L Engineering® Pinch Gauge 0-30 lb. in 1.0 lb.	eight weeks after intervention, eight weeks follow-up
Secondary	Change in walking speed	Timed Up and Go (TUG) test was to measure the duration for walking in seconds.	eight weeks after intervention, eight weeks follow-up