Effectiveness of Foot Exercise People With Type 2 Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Peripheral Neuropathy
• Intervention / Treatment: Other: Routine rehabilitation program patient education; Other: Routine rehabilitation program + foot exercise training

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Routine rehabilitation program patient education	Other: Routine rehabilitation program patient education; 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.
Experimental: Group B; Routine rehabilitation program + foot exercise training	Other: Routine rehabilitation program + foot exercise training; 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.

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

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Evrim Koçarslan, Researcher

Publications and helpful links

General Publications

• Francia P, Gulisano M, Anichini R, Seghieri G. Diabetic foot and exercise therapy: step by step the role of rigid posture and biomechanics treatment. Curr Diabetes Rev. 2014 Mar;10(2):86-99. doi: 10.2174/1573399810666140507112536.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: August 17, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: pain; foot exercise
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Endocrine System Diseases; Neuromuscular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Peripheral Nervous System Diseases
• Other Study ID Numbers: 199292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No