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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]

Nill known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 diabetes

Ischemic stroke

Hemiparesis

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Stroke

Ischaemic

Physical Medicine / Rehabilitation

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]

Rehabilitation

Intervention code [2]

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]

Efficacy of diabetes treatment evaluated on the basis of the blood glucose haemoglobin (HbA1C) concentration.

Timepoint [1]

At baseline and at week 12

Secondary outcome [1]

The effect of the treatment on the blood concentration of total cholesterol.

Timepoint [1]

At baseline and at week 12.

Secondary outcome [2]

The effect of the treatment on the blood concentration of LDL cholesterol fraction.

Timepoint [2]

At baseline and at week 12.

Secondary outcome [3]

The effect of the treatment on the blood concentration of HDL cholesterol fraction.

Timepoint [3]

At baseline and at week 12.

Secondary outcome [4]

The effect of the treatment on the blood triglyceride concentration.

Timepoint [4]

At baseline and at week 12.

Secondary outcome [5]

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]

At baseline and at week 12.

Secondary outcome [6]

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]

At baseline and at week 12.

Secondary outcome [7]

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]

At baseline and at week 12.

Secondary outcome [8]

Mean blood pressure values on 24 hour ambulatory blood pressure monitoring (ABPM).

Timepoint [8]

At baseline and at week 12.

Secondary outcome [9]

Effect of treatment on the concentration of transaminases in the blood.

Timepoint [9]

At baseline, and week 12

Secondary outcome [10]

Effect of treatment on the concentration of creatinine in the blood.

Timepoint [10]

At baseline, and week 12

Secondary outcome [11]

Effect of treatment on the concentration of electrolytes in the blood.

Timepoint [11]

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

Sex

Both males and females

Can healthy volunteers participate?

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

20/07/2015

Date of last participant enrolment

Anticipated

Actual

23/10/2017

Date of last data collection

Anticipated

Actual

29/01/2018

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Academy of Physical Education

Address [1]

Mikolowska 72A, 40-065 Katowice

Country [1]

Poland

Primary sponsor type

University

Name

Academy of Physical Education

Address

Mikolowska 72A, 40-065 Katowice

Country

Poland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Research Ethics Commitee from the Academy of Physical Education in Katowice, Poland

Ethics committee address [1]

Mikolowska 72A, 40-065 Katowice

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

17/09/2012

Approval date [1]

15/10/2012

Ethics approval number [1]

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

Prof Cezary Kucio

Address

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

Poland

Phone

+48322075301

Fax

c.kucio@awf.katowice.pl

Contact person for public queries

Name

Anna Polak

Address

Department of Physical Therapy, Academy of Physical Education, Mikolowska 72A, 40-065 Katowice.

Country

Poland

Phone

+48322075129

Fax

a.polak@awf.katowice.pl

Contact person for scientific queries

Name

Anna Polak

Address

Department of Physical Therapy, Academy of Physical Education, Mikolowska 72A, 40-065 Katowice.

Country

Poland

Phone

+48322075129

Fax

a.polak@awf.katowice.pl

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The combined effect of neuromuscular electrical stimulation and insulin therapy on glycated hemoglobin concentrations, lipid profiles and hemodynamic parameters in patients with type-2-diabetes and hemiplegia related to ischemic stroke: A pilot study.	2021	https://dx.doi.org/10.3390/ijerph18073433

N.B. These documents automatically identified may not have been verified by the study sponsor.

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