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Trial registered on ANZCTR


Registration number
ACTRN12618000486224
Ethics application status
Approved
Date submitted
22/10/2017
Date registered
4/04/2018
Date last updated
4/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of neuromuscular electrical stimulation (NMES) on the treatment of patients with type 2 diabetes.
Scientific title
Effect of neuromuscular electrostimulation (NMES) on the treatment of patients with type 2 diabetes suffering from hemiparesis caused by ischemic stroke. A pilot, randomized, controlled clinical study.
Secondary ID [1] 293181 0
Nill known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 305175 0
Ischemic stroke 305176 0
Hemiparesis 305177 0
Condition category
Condition code
Metabolic and Endocrine 304491 304491 0 0
Diabetes
Stroke 304493 304493 0 0
Ischaemic
Physical Medicine / Rehabilitation 304494 304494 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot, randomized, controlled clinical trial will be carried out to gain knowledge about the effect of lower extremity neuromuscular electrical stimulation (NMES) on the health status and life quality of patients with type 2 diabetes treated with insulin.

The study will compare the effects of treating adult patients with insulin only (the control group) and with insulin in conjunction with lower extremity NMES (the ES group) after 12 weeks of intervention.

All patients will be directed to the study following an examination by a physician. Patients will be thoroughly informed about the purpose and course of the study. Demographic information on the patients will be compiled during standardized interviews and physical examinations, as well as from additional examinations of the patients and the documentation of their concomitant diseases.

Patients will be enrolled for this clinical trial based on the results of medical examinations and additional tests, such as resting electrocardiography (ECG), echocardiography (USG),
24-hour ambulatory blood pressure monitoring (ABPM), laboratory tests (glucose, glycated haemoglobin, total lipid cholesterol and HDL fractions, LDL and triglycerides, creatinine, transaminase, electrolytes).

Patients in the experimental group will be treated with insulin following the clinical recommendations for the treatment of diabetic patients published by the Polish Diabetes Association.

Electrical stimulation
Additionally the experimental group will receive neuro-muscular electrical stimulation of the lower extremity muscles. Electrical stimulation will be performed using a portable dual-channel stimulation system TrioStim by Mettler Electronics. Biphasic, symmetrical, rectangular pulses (0.3 ms) at a frequency of 35 pulses/sec will be delivered to the quadriceps femoris and triceps surae of both lower extremities. Electrodes (5cm x 5cm) will be attached to the proximal and distal parts of the muscle bellies. Amperage will be set individually for each patient to ensure painless muscle contraction. A 2-second muscle contraction (time on) will be followed by a 4-second break (time off). NMES will be applied for 60 minutes. First both quadriceps will be stimulated for 30 minutes and then the triceps surae muscles for another 30 minutes. Treatments will be applied 5 days a week for 12 weeks (a total of 60 therapeutic sessions).

In each therapeutic session NMES will be performed on both lower limbs. During the first 20 minutes, the quadriceps muscles of the right and left lower limbs will be subjected to electrostimulation, and for the next 20 minutes the triceps of the calves of both lower limbs. In total, each therapeutic session will last 40 minutes

Before the start of a series of NMES treatments, all patients will be trained by the physiotherapist how to perform NMES. Patients will also be informed about the potential side effects of electrostimilation (eg skin irritation, painfulness during the procedure, etc.).

Patients will then perform their own NMES at home. Each electrostimulation treatment will be recorded by the patient in a special diary. Every day an SMS will be sent to the patient, reminding him that he needs to have NMES. Every two days the therapist will contact the patient by phone asking if the treatments were done and whether they were made
to the full extent.

In the case of side effects, the patient will contact the therapist or doctor, if necessary a therapist or doctor will come to the patient's home to check for any symptoms.

The duration of the battery supply to the ES is about 6-7 days, so once a week the therapist will come to the patient to replace the battery. The battery consumption will also be a confirmation of the NMES patients' performance.
Intervention code [1] 299434 0
Rehabilitation
Intervention code [2] 299435 0
Treatment: Devices
Comparator / control treatment
Patients in the control group will be treated with insulin following the clinical recommendations for the treatment of diabetic patients published by the Polish Diabetes Association.
Control group
Active

Outcomes
Primary outcome [1] 303728 0
Efficacy of diabetes treatment evaluated on the basis of the blood glucose haemoglobin (HbA1C) concentration.
Timepoint [1] 303728 0
At baseline and at week 12
Secondary outcome [1] 339980 0
The effect of the treatment on the blood concentration of total cholesterol.
Timepoint [1] 339980 0
At baseline and at week 12.
Secondary outcome [2] 339981 0
The effect of the treatment on the blood concentration of LDL cholesterol fraction.
Timepoint [2] 339981 0
At baseline and at week 12.
Secondary outcome [3] 339982 0
The effect of the treatment on the blood concentration of HDL cholesterol fraction.
Timepoint [3] 339982 0
At baseline and at week 12.
Secondary outcome [4] 339983 0
The effect of the treatment on the blood triglyceride concentration.
Timepoint [4] 339983 0
At baseline and at week 12.
Secondary outcome [5] 339984 0
The effect of the treatment on left ventricular ejection fraction (LVEF)
LVEF will be assessed by the routine method during transthoracic echocardiography. The test will be performed by a cardiologist using a VIVID 7 device (GE Healthcare, USA).
Timepoint [5] 339984 0
At baseline and at week 12.
Secondary outcome [6] 339985 0
The effect of the treatment on left ventricular late-diastolic dimension (LVEDD).
LVEDD will be assessed by the routine method during transthoracic echocardiography. The test will be performed by a cardiologist using a VIVID 7 device (GE Healthcare, USA).
Timepoint [6] 339985 0
At baseline and at week 12.
Secondary outcome [7] 339986 0
The effect of the treatment on left systolic dimension (LVESD).
LVESD will be assessed by the routine method during transthoracic echocardiography. The test will be performed by a cardiologist using a VIVID 7 device (GE Healthcare, USA).
Timepoint [7] 339986 0
At baseline and at week 12.
Secondary outcome [8] 339987 0
Mean blood pressure values on 24 hour ambulatory blood pressure monitoring (ABPM).
Timepoint [8] 339987 0
At baseline and at week 12.
Secondary outcome [9] 343515 0
Effect of treatment on the concentration of transaminases in the blood.
Timepoint [9] 343515 0
At baseline, and week 12
Secondary outcome [10] 343517 0
Effect of treatment on the concentration of creatinine in the blood.
Timepoint [10] 343517 0
At baseline, and week 12
Secondary outcome [11] 343518 0
Effect of treatment on the concentration of electrolytes in the blood.
Timepoint [11] 343518 0
At baseline, and week 12

Eligibility
Key inclusion criteria
Patient eligibility for the study will be established by their physician as per the following criteria:
1. Condition after ischemic stroke (3 months after the stroke at the earliest);
2. Documented type 2 diabetes treated with oral hypoglycaemic agents or insulin,
3. Haemoglobin glycated (HbA1c) below 9%,
4. BMI 25 - 40 kg / m2
5. Consent to participate in the study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Late complications of diabetes: retinopathy, neuropathy, diabetic nephropathy,
2. Older than 70 years,
3. Unstable coronary heart disease,
4. Valve defects requiring surgical correction,
5. Complex ventricular arrhythmias,
6. Implantation of cardiostimulator, cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D).
7. Acute myocarditis or pericarditis,
8. Uncontrolled hypertension,
9. Thromboembolism,
10. Chronic heart failure in the period of exacerbation,
11. Liver or kidney disease in the period of failure,
12. Chronic inflammatory diseases,
13. Alzheimer's and Parkinson's disease,
14. Inability to operate a portable two-channel electrostimulator,
15. Refusal to participate in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The selected patients who will give their consent to participate in the study will
be randomly assigned to the control group (insulin) or the experimental group (insulin plus NMES) using a concealed process.

Patient allocation to groups will be independent of when and who will deliver the treatment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with numbered envelopes will be employed. Each envelope will contain a piece of paper with the letter A (the control group) or B (the ES group). The envelopes will be randomly numbered and delivered to the project manager by a person uninvolved in the study. After the patients are enrolled, the envelopes will be opened one by one and the respective patient will be allocated to the group indicated by the letter.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
All patients in the study will be assessed at baseline to establish the homogeneity of distribution of their characteristics: age, BMI, concomitant diseases, concentration of glycated haemoglobin and lipids in circulating blood, results of 24 hour ambulatory blood pressure monitoring, and echocardiographic examination (LVEF, LVEDD, LVESD).

Depending on the distribution of variables, the results will be examined statistically using parametric or nonparametric tests. The between-group comparisons will involve: 1) changes in the concentration of glycated haemoglobin; 2) changes in the concentration of triglyceride and in total cholesterol and its LDL and HDL fractions; 3) changes in 24 hour ambulatory blood pressure monitoring values; 4) changes in left ventricular ejection fraction (LVEF), left ventricular late-diastolic dimension (LVEDD) and left ventricular systolic dimension (LVESD). The level of statistical significance for all tests will be p < 0.05.

Statistical analysis will be performed using the Statistica software by StatSoft (licensed to the Academy of Physical Education in Katowice).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9306 0
Poland
State/province [1] 9306 0

Funding & Sponsors
Funding source category [1] 297811 0
University
Name [1] 297811 0
Academy of Physical Education
Address [1] 297811 0
Mikolowska 72A, 40-065 Katowice
Country [1] 297811 0
Poland
Primary sponsor type
University
Name
Academy of Physical Education
Address
Mikolowska 72A, 40-065 Katowice
Country
Poland
Secondary sponsor category [1] 296853 0
None
Name [1] 296853 0
Address [1] 296853 0
Country [1] 296853 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298868 0
The Research Ethics Commitee from the Academy of Physical Education in Katowice, Poland
Ethics committee address [1] 298868 0
Mikolowska 72A, 40-065 Katowice
Ethics committee country [1] 298868 0
Poland
Date submitted for ethics approval [1] 298868 0
17/09/2012
Approval date [1] 298868 0
15/10/2012
Ethics approval number [1] 298868 0
9 / 2012 of October, 10, 2012

Summary
Brief summary
NMES is commonly used to strengthen muscles undergoing atrophy from inactivity. According to some studies, NMES can also have a positive effect on the rehabilitation of individuals suffering with chronic heart failure, chronic obstructive pulmonary disease and on the sarcopenic elderly.
Studies have also been published on the use of NMES in the non-pharmacological treatment of type 2 diabetic patients. Among others, patients with diabetes mellitus and coexisting obesity, musculoskeletal disorders (especially arthritis and sarcopenia) and neurological injuries have been studied. The results of the studies are inconsistent and do not allow definite conclusions on NMES effect in the treatment of diabetic patients to be drawn.
Poole et al. (Diabetes Obes Metab 2005) have not shown NMES to contribute to clinically significant changes in patients with type 2 diabetes. In contrast, Crowe and Caulfield (BMJ 2012) found NMES to have caused significant reduction in glycated haemoglobin (HbA1c) levels in patients with type 2 diabetes. In studies involving patients with type 2 diabetes and concomitant sarcopenia NMES has increased the synthesis of protein in the lower limb of stimulation, leading their authors to a conclusion that NMES may slow muscle loss in such patients (Wall et al. Am J Physiol Endocrino Metab, 2012). In patients with type 2 diabetes NMES improved insulin sensitivity (Joubert et al. Acta Diabetol, 2015), decreased plasma glucose (Jabbour et al. Diabetes Metab J 2015; Sinacore et al. Phys Ther, 1990), and increased glycolytic muscle type II (Sinacore et al. Phys Ther, 1990).
The cited results encourage the use of NMES in diabetic patients. Our study will expand the knowledge of the effects of lower extremity skeletal muscle NMES in the treatment
of patients with type 2 diabetes suffering from hemiparesis due to ischemic stroke.
Our study is specifically designed to test the following hypotheses:
In patients with hemiparesis after ischemic stroke with type II diabetes:
1) NMES reduces the concentration of glycated haemoglobin in circulating blood.
2) NMES reduces circulating blood lipid concentration.
3) NMES helps improve the haemodynamic parameters of the heart (LVEF, LVEDD, LVESD).
4) NMES decreases blood pressure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78494 0
Prof Cezary Kucio
Address 78494 0
Department of Physical Therapy, Academy of Physical Education, Mikolowska 72A, 40-065 Katowice.
Department of Internal Medicine, Multi-specialized Hospital, Chelmonskiego 28, 43-609 Jaworzno,
Country 78494 0
Poland
Phone 78494 0
+48322075301
Fax 78494 0
Email 78494 0
c.kucio@awf.katowice.pl
Contact person for public queries
Name 78495 0
Dr Anna Polak
Address 78495 0
Department of Physical Therapy, Academy of Physical Education, Mikolowska 72A, 40-065 Katowice.
Country 78495 0
Poland
Phone 78495 0
+48322075129
Fax 78495 0
Email 78495 0
a.polak@awf.katowice.pl
Contact person for scientific queries
Name 78496 0
Dr Anna Polak
Address 78496 0
Department of Physical Therapy, Academy of Physical Education, Mikolowska 72A, 40-065 Katowice.
Country 78496 0
Poland
Phone 78496 0
+48322075129
Fax 78496 0
Email 78496 0
a.polak@awf.katowice.pl

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary