Effectiveness of Foot Exercise People With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of this study will to investigate the effect of foot exercises in patients with type 2 diabetic and peripheral neuropathy. Subjects will be randomly allocated to either the control or intervention group. Data will be collected using investigator-developed forms: patient information form and the diabetic foot exercises log. Patients in the intervention group will be received standard treatment and performed foot exercises for three times a week 8 weeks; the control group will be received standard treatment but no exercises. The intervention and control groups will be examined and measured at the 4th and 8th weeks.

Detailed Description
-----------------
Purpose of our study investigation of the effects foot exercises in patients with type 2 diabetic and peripheral neuropathy. Excepted results: Routine treatment + foot exercises pain, flexibility, edema, muscle strength, sensation, quality of life we believe that there will be good progress in peripheral neuropathy effects, Leeds assessment of neuropathic symptoms and signs(LANSS) results. In this context, it is planned that patients randomly divided into 2 groups. Group 1 control group. Group 2 intervention group. Patients in the intervention group will be received standard treatment and performed foot exercises for three times a week 8 weeks. The patients will be evaluated by clinical measurements and scales based on patient notification at the 4th and 8th weeks.

Official Title
-----------------
Effectiveness of Foot Exercise Training on Patients With Type 2 Diabetes and Peripheral Neuropathy

Conditions
-----------------
Diabetes Mellitus, Type 2, Peripheral Neuropathy

Intervention / Treatment
-----------------
* Other: Routine rehabilitation program patient education
* Other: Routine rehabilitation program + foot exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having type 2 diabetes mellitus for 5 years HbA1c > among of between 6.5-10 Having grade 0 or 1 phase of Wagner classification Diabetic neuropathy score ≥ 3 Exclusion Criteria: Not to know turkish Having hearing, visual and speaking problems Having (except diabetic neuropathy) other neurologic problems Having psychiatric and cognitive problems Having orthopedic, rheumatologic, cardiac, and pulmonary problems which stopping exercise

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Routine rehabilitation program patient education | Other: Routine rehabilitation program patient education<br>* Patient education All the patients were assessed with Wagner Classification, Diabetic Neuropathy Symptom (DNS) score, Diabetic Neuropathy Examination (DNE) score, Visual Analogue Scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS), hand-held dynamometer, range of motion measurements, Semmes-Weinstein monofilament, two point discrimination test, circumference measurements, Foot and Ankle Ability Measure(FAAM), 6-minute walk test (6MWT) before and after the treatment.<br>|
| Experimental: Group B<br>Routine rehabilitation program + foot exercise training | Other: Routine rehabilitation program + foot exercise training<br>* In addition to the patient education , foot exercise training will be performed. Patients will be applied exercise training consisted of aerobic, strengthening, sensory training and stretching exercises for 3 days/week, 8 weeks. All the patients were assessed with Wagner Classification, Diabetic Neuropathy Symptom (DNS) score, Diabetic Neuropathy Examination (DNE) score, Visual Analogue Scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS) ,hand-held dynamometer,range of motion measurements, Semmes-Weinstein monofilament, two point discrimination test,circumference measurements, Foot and Ankle Ability Measure(FAAM), 6-minute walk test (6MWT) before and after the treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment with Algometry | An instrument for determining sensitivity to pain produced by pressure. | Change from Baseline Pain at 8 weeks | 
| Pain assessment with The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale | The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale evaluates sensory dysfunction and whether the pain is caused by neuropathic mechanisms or not. The LANSS comprises a 5-item questionnaire regarding pain symptoms and two items for clinical signs involving self-administered sensory tests for the presence of allodynia and decreased sensation to pinprick. Responses to each item are binary (yes or no) and each item is weighted differently depending on the odds ratio of a positive response to each item to predict that the pain is primarily neuropathic. The possible scores range from 0 to 24, with a score of 12 or greater considered to be suggestive of neuropathic pain | Change from Baseline Pain at 8 weeks | 
| Pain assessment With Visual Analog Scale | Participants are asked to mark the point where they feel their pain on a 10 centimeter (cm) horizontal line. 0-no pain, 10-unbearable pain. Night, activity and pain conditions are evaluated separately at rest. | Change from Baseline Pain at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength with Hand held dynamometer | The Hand-Held Dynamometer (formerly known as the Manual Muscle Tester) is an ergonomic hand-held device for objectively quantifying muscle strength. | 1th day, 8th week | 
| Range Of Motion with goniometer | A goniometer is a device used in physical therapy to measure the range of motion around a joint in the body. | 1th day, 8th week | 
| Baseline Tactile Semmes-Weinstein Monofilament | Baseline Tactile Semmes-Weinstein Monofilaments are designed to measure cutaneous sensory perception threshold of a patient. | 1th day, 8th week | 
| Edema measurement of tape | Use a measuring tape to measure the circumference of your leg. Write down its circumference and repeat daily for a few days, using the same area on your the leg. | 1th day, 8th week | 
| Evaluation of functional capacity with 6 minutes walking test | The 6-minute walk test is one of the functional exercise capacity assessment tests. In this test, participants are asked to walk as long as possible within 6 minutes in a 30 meter (m) corridor. When they feel fatigue or pain, they are advised to stop and rest when they feel ready to walk. At the end of 6 minutes, the total distance of the patients walking is recorded. Heart rates, systolic and diastolic blood pressures, O2 saturation, perceived fatigue and dyspnea levels are recorded before and after the test. | 1th day, 8th week | 
| Two Point Discrimation Test | The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception. | 1th day, 8th week | 
| The Foot and Ankle Ability Measure | The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. | 1th day, 8th week | 
| HbA1c | HbA1c (A1c or glycosylated hemoglobin) is widely used as the most important marker for routine monitoring of long term glycemic status in patients with diabetes. | 1 th day, 8th week | 
| Serum creatinine | The kidneys are responsible for keeping the level of creatinine in the blood within a normal range. The typical reference range for serum creatinine is 60 to 110 micromoles per liter (μmol/L) (0.7 to 1.2 milligrams per deciliter (mg/dL)) for men and 45 to 90 μmol/L (0.5 to 1.0 mg/dL) for women. | 1 th day, 8th week | 
| Albumin levels | A normal albumin range is 3.4 to 5.4 g/dL. If you have a lower albumin level, you may have malnutrition. It can also mean that you have liver disease or an inflammatory disease. Higher albumin levels may be caused by acute infections, burns, and stress from surgery or a heart attack. | 1 th day, 8th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
foot exercise, pain