Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy

NCT03450200 | Completed

• 2 other identifiers: D16-07Ethics/DMR/2017/048
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetic Peripheral Neuropathy, Exercises

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in strength of hand grip

  eight weeks after intervention, eight weeks follow-up

• Change in strength of pinch force

  eight weeks after intervention, eight weeks follow-up

• Change in walking speed

  eight weeks after intervention, eight weeks follow-up

Study Arms (2)

Exercises Group

EXPERIMENTAL

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; Other: Health education for diabetic foot care

Control Group

OTHER

health education about diabetic foot care

Other: Health education for diabetic foot care

Interventions

exercises for diabetic peripheral neuropathy OTHER

Hands, fingers, and foot exercises for diabetic peripheral neuropathy to improve activities of daily living, and decreases the signs and symptoms of DPN

Exercises Group

Health education for diabetic foot care OTHER

Health education for daily diabetic foot care to prevent diabetic foot ulcer was provided.

Control Group; Exercises Group

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Okayama University: lead

Study Sites (1)

Okayama University

Okayama, 7008558, Japan

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mi Mi Thet Mon Win, PhD student

  Graduate School of Health Sciences, Okayama University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 1, 2018
• Study Start: June 17, 2017
• Primary Completion: October 16, 2017
• Study Completion: October 16, 2017
• Last Updated: May 10, 2019

Record last verified: 2019-05

Locations

JP (1)