Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy

• ClinicalTrials.gov Identifier: NCT03450200
• Recruitment Status: Completed
• First Posted: March 1, 2018
• Last Update Posted: May 10, 2019
• Sponsor: Okayama University
• Information provided by (Responsible Party): Mi Mi Thet Mon Win, Okayama University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Peripheral Neuropathy	Other: exercises for diabetic peripheral neuropathy; Other: Health education for diabetic foot care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy
• Actual Study Start Date: June 17, 2017
• Actual Primary Completion Date: October 16, 2017
• Actual Study Completion Date: October 16, 2017

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change in strength of hand grip [ Time Frame: eight weeks after intervention, eight weeks follow-up ]
   Hand grip was measured in kilograms by using TTM original Dynamometer 100 kg.
2. Change in strength of pinch force [ Time Frame: 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.
3. Change in walking speed [ Time Frame: eight weeks after intervention, eight weeks follow-up ]
   Timed Up and Go (TUG) test was to measure the duration for walking in seconds.

Eligibility Criteria

• Ages Eligible for Study: 25 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Japan

Okayama University

Okayama, Japan, 7008558

Sponsors and Collaborators

Okayama University

Investigators

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

More Information

• Responsible Party: Mi Mi Thet Mon Win, Graduate Student, Okayama University
• ClinicalTrials.gov Identifier: NCT03450200
• Other Study ID Numbers: D16-07; Ethics/DMR/2017/048 ( Other Identifier: Department of Medical Research, Myanmar )
• First Posted: March 1, 2018
• Last Update Posted: May 10, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mi Mi Thet Mon Win, Okayama University:

Diabetic Peripheral Neuropathy, Exercises

Additional relevant MeSH terms:

Peripheral Nervous System Diseases; Diabetic Neuropathies; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases