| CTRI Number |
CTRI/2024/10/075562 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing How Electrical Stimulation of Leg Muscles Affects Blood Sugar Levels in People with Diabetes |
|
Scientific Title of Study
|
comparative effectiveness of neuromuscular electrical stimulation of soleus and quadriceps muscle on blood glucose level in people with diabetes mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Kumari Gupta |
| Designation |
Postgraduate student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy, Delhi |
| Address |
Physiotherapy department, Exercise therapy laboratory 1, Room no 1, 2nd floor, Amar Jyoti Institute of Physiotherapy, Karkardooma, Delhi, India
East
DELHI
110092
India |
| Phone |
09205575491 |
| Fax |
|
| Email |
sanagupta711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sampada S. Jahargirdar |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Physiotherapy department, Exercise therapy laboratory 1, Room no. 1, 2nd floor, Amar Jyoti Institute of Physiotherapy, Karkardooma, Delhi, India
East
DELHI
110092
India |
| Phone |
9810991128 |
| Fax |
|
| Email |
s.jahagirdar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sampada S. Jahargirdar |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Physiotherapy department, Exercise therapy laboratory 1, Room no 1, 2nd floor, Amar Jyoti Institute of Physiotherapy, Karkardooma, Delhi, India
East
DELHI
110092
India |
| Phone |
9810991128 |
| Fax |
|
| Email |
s.jahagirdar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Amar Jyoti Institute of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Amar Jyoti Institute of Physiotherapy |
| Address |
Amar Jyoti Institute of Physiotherapy, Karkardooma, Delhi, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalini Kumari Gupta |
Amar Jyoti Institute of Physiotherapy |
Physiotherapy department, Exercise laboratory 1, Room no. 1, 2nd floor, Vikas Marg, Karkardooma, Delhi,110092
East
DELHI |
9205575491
sanagupta711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amar Jyoti Institutional Review Board- Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Participants will receive Neuromuscular Electrical Stimulation (NMES) on Soleus Muscle + Conventional Physiotherapy treatment |
Following the baseline measurement and assessment of outcome measures, group a will receive conventional treatment including supervised active exercise- aerobic for 150 mins per week and resistance exercise for 3days per week over 3 weeks. Aerobic exercise includes walking- 30mins/day whereas resistance exercise targets major muscle groups which includes squats, seated knee extension , standing knee flexion, biceps curls, shoulder flexion, shoulder extension, shoulder abduction, shoulder adduction, overhead triceps, floor chest press with weight cuff and crunches)and NMES on soleus muscle [parameters- frequency: 50 Hz ,waveform – biphasic .pulse width: 300 μs (0.3ms),duration: 30 minutes per session] for 3weeks (5 day/week). |
| Intervention |
Group B: Participants will receive Neuromuscular Electrical Stimulation (NMES) on Quadriceps Muscle + Conventional Physiotherapy treatment |
Following the baseline measurement and assessment of outcome measures, group a will receive conventional treatment including supervised active exercise- aerobic for 150 mins per week and resistance exercise for 3days per week over 3 weeks. Aerobic exercise includes walking- 30mins/day whereas resistance exercise targets major muscle groups which includes squats, seated knee extension , standing knee flexion, biceps curls, shoulder flexion, shoulder extension, shoulder abduction, shoulder adduction, overhead triceps, floor chest press with weight cuff and crunches)and NMES on soleus muscle [parameters- frequency: 50 Hz ,waveform – biphasic .pulse width: 300 μs (0.3ms),duration: 30 minutes per session] for 3weeks (5 day/week). |
| Comparator Agent |
Group-C Participants will receive aerobic+ resistance exercises as Conventional Physiotherapy treatment. |
Following the baseline measurement and assessment of outcome measures, group a will receive conventional treatment including supervised active exercise- aerobic for 150 mins per week and resistance exercise for 3days per week over 3 weeks. Aerobic exercise includes walking- 30mins/day whereas resistance exercise targets major muscle groups which includes squats, seated knee extension , standing knee flexion, biceps curl, shoulder flexion, shoulder extension, shoulder abduction, shoulder adduction, overhead triceps, floor chest press with weight cuff and crunches). |
|
|
Inclusion Criteria
|
| Age From |
41.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individual with diagnosed type 2 diabetes mellitus, individuals having diabetes mellitus≥ 5 years.
Hba1c levels above 6.5%
Individual having on stable medication regimen for diabetes control.
Individuals who are physically able to participate in the study.
Individual who are willing to undergo blood glucose monitoring.
Individual who has ability to understand spoken instruction
|
|
| ExclusionCriteria |
| Details |
Individual with type 1 diabetes (T1DM)
Individual with neurological conditions
Pregnant women
Cardiovascular complications
Severe musculoskeletal injuries or conditions hindering exercise
Recent major surgeries
Use of other neuromuscular stimulation devices
Active infections or inflammatory conditions
Uncontrolled hypertension
History of seizures
Allergies or sensitivities to NMES equipment.
Individual who are part of other research study
Individuals with altered sensations.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral Glucose Tolerance Test |
Baseline measurements will be obtained for Fasting Blood Glucose Levels and after Loading of Glucose. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim-The purpose of this study is to compare the effectiveness of neuromuscular electrical stimulation (NMES) targeting the soleus and quadriceps muscles with conventional exercises in reducing blood glucose levels in individuals with type 2 diabetes mellitus (T2DM). Background and need of the study- While lifestyle modifications and pharmacotherapy are essential for managing T2DM, there is a need for alternative, drug-free therapeutic interventions, particularly for patients who struggle with adhering to exercise programs recommended by the American College of Sports Medicine (ACSM). NMES has shown potential as an adjunct therapy to reduce blood glucose levels, particularly in the quadriceps muscle. However, its efficacy in comparison to exercise remains unclear, and the specific impact on glucose regulation when targeting muscle groups like the soleus and quadriceps has not been fully explored. This study seeks to fill this gap by investigating the effects of NMES on glucose metabolism in these key muscle groups, potentially offering new insights into non-pharmacological approaches to improve glycemic control in T2DM patients. Method- This prospective randomized controlled trial will include participants with T2DM aged 40-65 years of both genders. Participants will be randomized into three groups: NMES applied to the quadriceps, NMES applied to the soleus, and a control group performing conventional exercises. The trial will be conducted at the Amar Jyoti Institute of Physiotherapy in Delhi-NCR, India, and ethical approval will be obtained prior to the study. The results will measure blood glucose uptake post-intervention, allowing for a comparison of the effects of NMES on the quadriceps and soleus muscles versus exercise. Results- The study may show that NMES could be easily added to diabetes care plans and worked well for people who had trouble with regular exercise. Stimulating the soleus and quadriceps muscles may helped improve the way their bodies used glucose, leading to better control of blood sugar levels. These muscles, which are important for walking and supporting body weight, showed positive results after using NMES. Conclusion: NMES can be a helpful addition to diabetes treatment alongside medications. It can improve blood sugar control and reduce the need for medication, helping to lower the risk of long-term complications from diabetes. This may makes NMES a simple and useful option for people who can’t do traditional exercise. |