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Effectiveness of Foot Exercise People With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2, Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Routine rehabilitation program patient education
Routine rehabilitation program + foot exercise training
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring foot exercise, pain

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

Routine rehabilitation program patient education

Routine rehabilitation program + foot exercise training

Outcomes

Primary Outcome Measures

Pain assessment with Algometry
An instrument for determining sensitivity to pain produced by pressure.
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
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.

Secondary Outcome Measures

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.
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.
Baseline Tactile Semmes-Weinstein Monofilament
Baseline Tactile Semmes-Weinstein Monofilaments are designed to measure cutaneous sensory perception threshold of a patient.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 17, 2019
Last Updated
April 9, 2020
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04064996
Brief Title
Effectiveness of Foot Exercise People With Type 2 Diabetes
Official Title
Effectiveness of Foot Exercise Training on Patients With Type 2 Diabetes and Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Peripheral Neuropathy
Keywords
foot exercise, pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Routine rehabilitation program patient education
Arm Title
Group B
Arm Type
Experimental
Arm Description
Routine rehabilitation program + foot exercise training
Intervention Type
Other
Intervention Name(s)
Routine rehabilitation program patient education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine rehabilitation program + foot exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain assessment with Algometry
Description
An instrument for determining sensitivity to pain produced by pressure.
Time Frame
Change from Baseline Pain at 8 weeks
Title
Pain assessment with The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
Description
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
Time Frame
Change from Baseline Pain at 8 weeks
Title
Pain assessment With Visual Analog Scale
Description
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.
Time Frame
Change from Baseline Pain at 8 weeks
Secondary Outcome Measure Information:
Title
Muscle Strength with Hand held dynamometer
Description
The Hand-Held Dynamometer (formerly known as the Manual Muscle Tester) is an ergonomic hand-held device for objectively quantifying muscle strength.
Time Frame
1th day, 8th week
Title
Range Of Motion with goniometer
Description
A goniometer is a device used in physical therapy to measure the range of motion around a joint in the body.
Time Frame
1th day, 8th week
Title
Baseline Tactile Semmes-Weinstein Monofilament
Description
Baseline Tactile Semmes-Weinstein Monofilaments are designed to measure cutaneous sensory perception threshold of a patient.
Time Frame
1th day, 8th week
Title
Edema measurement of tape
Description
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.
Time Frame
1th day, 8th week
Title
Evaluation of functional capacity with 6 minutes walking test
Description
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.
Time Frame
1th day, 8th week
Title
Two Point Discrimation Test
Description
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.
Time Frame
1th day, 8th week
Title
The Foot and Ankle Ability Measure
Description
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.
Time Frame
1th day, 8th week
Title
HbA1c
Description
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.
Time Frame
1 th day, 8th week
Title
Serum creatinine
Description
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.
Time Frame
1 th day, 8th week
Title
Albumin levels
Description
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.
Time Frame
1 th day, 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evrim Koçarslan
Organizational Affiliation
researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24807636
Citation
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.
Results Reference
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Effectiveness of Foot Exercise People With Type 2 Diabetes

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