Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Other: exercises for diabetic peripheral neuropathy
* Other: Health education for diabetic foot care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercises Group<br>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<br>* Hands, fingers, and foot exercises for diabetic peripheral neuropathy to improve activities of daily living, and decreases the signs and symptoms of DPN<br>Other: Health education for diabetic foot care<br>* Health education for daily diabetic foot care to prevent diabetic foot ulcer was provided.<br>|
| Other: Control Group<br>health education about diabetic foot care | Other: Health education for diabetic foot care<br>* Health education for daily diabetic foot care to prevent diabetic foot ulcer was provided.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Peripheral Neuropathy, Exercises