Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy

NCT ID: NCT03450200

Last Updated: 2019-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-17
• Study Completion Date: 2017-10-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

exercises for diabetic peripheral neuropathy

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Control Group

health education about diabetic foot care

Group Type: OTHER

Health education for diabetic foot care

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Health education for diabetic foot care

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Okayama University

OTHER

Sponsor Role: lead

Responsible Party

Mi Mi Thet Mon Win

Graduate Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mi Mi Thet Mon Win, PhD student

Role: PRINCIPAL_INVESTIGATOR

Graduate School of Health Sciences, Okayama University

Locations

Okayama University

Okayama, , Japan

Countries

Japan

Other Identifiers

Ethics/DMR/2017/048

Identifier Type: OTHER

Identifier Source: secondary_id

D16-07

Identifier Type: -

Identifier Source: org_study_id