Diabetes Mellitus, Type 2NCT04064996
Effectiveness of Foot Exercise People With Type 2 Diabetes
A study testing Routine rehabilitation program patient education and Routine rehabilitation program + foot exercise training in people with Diabetes Mellitus, Type 2 and Peripheral Neuropathy, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Peripheral Neuropathy
- What is being tested?
- Routine rehabilitation program patient education and Routine rehabilitation program + foot exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Peripheral Neuropathy
- Being tested
- Routine rehabilitation program patient education, Routine rehabilitation program + foot exercise training
- Keywords
- foot exercise, pain
- Medical subject headings
- Diabetes Mellitus, Type 2, Peripheral Nervous System Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine rehabilitation program patient educationOther
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.
Routine rehabilitation program + foot exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Routine rehabilitation program patient education Receives: Other: Routine rehabilitation program patient education |
| Group B | Experimental | Routine rehabilitation program + foot exercise training Receives: Other: Routine rehabilitation program + foot exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment with Algometry
An instrument for determining sensitivity to pain produced by pressure.
Measured: 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
Measured: 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.
Measured: Change from Baseline Pain at 8 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 th day, 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Apr 2019
- Primary completion30 Jul 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evrim KOÇARSLAN, Istanbul University
- Investigators
- Evrim Koçarslan, Principal investigator, researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064996
- Sponsor's protocol ID
- 199292
- Status last verified
- Apr 2020
- First submitted
- 17 Aug 2019
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24807636
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Foot Exercise Training on Patients With Type 2 Diabetes and Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT04064996
- Acronym / sponsor ID
- 199292
- Conditions
- Diabetes Mellitus, Type 2, Peripheral Neuropathy
- Keywords
- foot exercise, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Routine rehabilitation program patient educationRoutine rehabilitation program patient education |
| Group B | Experimental | Other: Routine rehabilitation program + foot exercise trainingRoutine rehabilitation program + foot exercise training |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine rehabilitation program patient educationPatient 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. | Other | Group A |
| Routine rehabilitation program + foot exercise trainingIn 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. | Other | Group B |
Primary outcome
Pain assessment with Algometry
Time frame: Change from Baseline Pain at 8 weeks
An instrument for determining sensitivity to pain produced by pressure.
Pain assessment with The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
Time frame: Change from Baseline Pain at 8 weeks
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
Time frame: Change from Baseline Pain at 8 weeks
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.
10 secondary outcomes
Muscle Strength with Hand held dynamometer
Time frame: 1th day, 8th week
Range Of Motion with goniometer
Time frame: 1th day, 8th week
Baseline Tactile Semmes-Weinstein Monofilament
Time frame: 1th day, 8th week
Edema measurement of tape
Time frame: 1th day, 8th week
Evaluation of functional capacity with 6 minutes walking test
Time frame: 1th day, 8th week
Two Point Discrimation Test
Time frame: 1th day, 8th week
The Foot and Ankle Ability Measure
Time frame: 1th day, 8th week
HbA1c
Time frame: 1 th day, 8th week
Serum creatinine
Time frame: 1 th day, 8th week
Albumin levels
Time frame: 1 th day, 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Background: PubMed 24807636Francia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evrim Koçarslan principal investigator
researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine rehabilitation program patient education and Routine rehabilitation program + foot exercise training in people with Diabetes Mellitus, Type 2 and Peripheral Neuropathy, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment with Algometry (time frame: Change from Baseline Pain at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04064996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.