Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Other: exercises for diabetic peripheral neuropathy; Other: Health education for diabetic foot care

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Okayama, Japan, 7008558
    • Okayama University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercises Group; 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	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; Other: Health education for diabetic foot care; Health education for daily diabetic foot care to prevent diabetic foot ulcer was provided.
OTHER: Control Group; health education about diabetic foot care	Other: Health education for diabetic foot care; Health education for daily diabetic foot care to prevent diabetic foot ulcer was provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Okayama University
• Investigators: Principal Investigator: Mi Mi Thet Mon Win, PhD student, Graduate School of Health Sciences, Okayama University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 17, 2017
• Primary Completion (ACTUAL): October 16, 2017
• Study Completion (ACTUAL): October 16, 2017

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (ACTUAL): March 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Diabetic Peripheral Neuropathy, Exercises
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: D16-07; Ethics/DMR/2017/048 (OTHER: Department of Medical Research, Myanmar)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No