Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy
Primary Purpose
Diabetic Peripheral Neuropathy
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
exercises for diabetic peripheral neuropathy
Health education for diabetic foot care
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetic Peripheral Neuropathy focused on measuring Diabetic Peripheral Neuropathy, Exercises
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
Sites / Locations
- Okayama University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Exercises Group
Control Group
Arm Description
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
health education about diabetic foot care
Outcomes
Primary Outcome Measures
Change in Activities of daily living (ADLs) after intervention, at follow-up
ADLs were measured by using Patient Neurotoxicity Questionnaire (PNQ).
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.
Change in signs of DPN after intervention, at follow-up
DPN was assessed by tuning fork vibration test.
Secondary Outcome Measures
Change in strength of hand grip
Hand grip was measured in kilograms by using TTM original Dynamometer 100 kg.
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.
Change in walking speed
Timed Up and Go (TUG) test was to measure the duration for walking in seconds.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03450200
Brief Title
Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy
Official Title
Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 17, 2017 (Actual)
Primary Completion Date
October 16, 2017 (Actual)
Study Completion Date
October 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okayama University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
Keywords
Diabetic Peripheral Neuropathy, Exercises
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercises Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Other
Arm Description
health education about diabetic foot care
Intervention Type
Other
Intervention Name(s)
exercises for diabetic peripheral neuropathy
Intervention Description
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
Intervention Name(s)
Health education for diabetic foot care
Intervention Description
Health education for daily diabetic foot care to prevent diabetic foot ulcer was provided.
Primary Outcome Measure Information:
Title
Change in Activities of daily living (ADLs) after intervention, at follow-up
Description
ADLs were measured by using Patient Neurotoxicity Questionnaire (PNQ).
Time Frame
eight weeks after intervention, eight weeks follow-up
Title
Change in signs of DPN after intervention, at follow-up
Description
DPN was assessed by using monofilament (SMW), Touch-TestTM Sensory Evaluator 5 Pieces Hand Kit of North Coast Medical Inc.
Time Frame
eight weeks after intervention, eight weeks follow-up
Title
Change in signs of DPN after intervention, at follow-up
Description
DPN was assessed by tuning fork vibration test.
Time Frame
eight weeks after intervention, eight weeks follow-up
Secondary Outcome Measure Information:
Title
Change in strength of hand grip
Description
Hand grip was measured in kilograms by using TTM original Dynamometer 100 kg.
Time Frame
eight weeks after intervention, eight weeks follow-up
Title
Change in strength of pinch force
Description
Key (lateral pinch) was measured by the gold standard B&L Engineering® Pinch Gauge 0-30 lb. in 1.0 lb.
Time Frame
eight weeks after intervention, eight weeks follow-up
Title
Change in walking speed
Description
Timed Up and Go (TUG) test was to measure the duration for walking in seconds.
Time Frame
eight weeks after intervention, eight weeks follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi Mi Thet Mon Win, PhD student
Organizational Affiliation
Graduate School of Health Sciences, Okayama University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Okayama University
City
Okayama
ZIP/Postal Code
7008558
Country
Japan
12. IPD Sharing Statement
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Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy
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