| CTRI Number |
CTRI/2021/07/035031 [Registered on: 22/07/2021] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of diabetes on muscle strength |
|
Scientific Title of Study
|
Analysis of neuromuscular physiological changes in type II diabetic mellitus clients following medium frequency electrical stimulation.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riyas Basheer K B |
| Designation |
Research Scholar |
| Affiliation |
Tejasvini Physiotherapy College |
| Address |
Tejasvini Physiotherapy College
Tejasvini Hospital Group of Institutions
Kudupu
Mangalore
Karnataka
575028
Research Scholar
Srinivas University
Mukka
Mangalore
Karnataka
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
9995092825 |
| Fax |
|
| Email |
riyas2423@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh K V |
| Designation |
Professor |
| Affiliation |
Srinivas Institute of Medical Sciences |
| Address |
Srinivas Institute of Medical Sciences
Mangalore
Karnataka
Dakshina Kannada
KARNATAKA
574146
India |
| Phone |
9880119797 |
| Fax |
|
| Email |
dineshkvn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Riyas Basheer K B |
| Designation |
Research Scholar |
| Affiliation |
Tejasvini Physiotherapy College |
| Address |
Tejasvini Physiotherapy College
Tejasvini Hospital Group of Institutions
Kudupu
Mangalore
Karnataka
575028
Research Scholar
Srinivas University
Mukka
Mangalore
Karnataka
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
9995092825 |
| Fax |
|
| Email |
riyas2423@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tejasvini Physiotherapy College, Tejasvini Hospital Group of Institutions, Kudupu, Mangalore, Karnataka-575028 |
|
|
Primary Sponsor
|
| Name |
Riyas Basheer K B |
| Address |
Assistant Professor
Tejasvini Physiotherapy College
Tejasvini Hospital Group of Institutions
Kudupu
Mangalore
Karnataka
575028 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mohammed Arshak |
Kenz Rehab |
Physiotherapy Centre
Koppam
Palakkad
Kerala
Palakkad
KERALA |
9746112004
atm.arshak@gmail.com |
| Jazeel N M |
Malabar Medical College Hospital & Research Centre |
Physiotherapy Department
Modakkalloor
Kozhikode
Kerala
Kozhikode
KERALA |
974947794
jazeelnm@gmail.com |
| Dr Dinesh K V |
Srinivas Institutte of Medical Sciences |
Dept of Orthopedics & Physiotherapy
Mukka
Mangalore
Dakshina Kannada
KARNATAKA |
9880119797
dineshkvn@gmail.com |
| Riyas Basheer |
Tejasvini Hospital |
Physiotherapy Department
Kadri
Mangalore
Karnataka
Dakshina Kannada
KARNATAKA |
9400092825
riyas2423@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srinivas University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medium Frequency Current |
Russian Current Stimulation
Burst Frequency: 50 Hz
On: Off TIme: 10 ms on, 10 ms off
50% Duty Cycle
|
| Comparator Agent |
Strength Training |
ACSM Guidleines for STrength Training
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 DM
Presence of microvascular complications
|
|
| ExclusionCriteria |
| Details |
Diabetes other than Type 2
Stroke or other diseases that reducing the muscle strength
Psychologically unstable individuals
Not willing for consent
Recent injuries to upper and lower limb |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Muscle Strength by using Hand Held Dynamometer |
at Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum Creatine |
1.3 mg/dL |
| FBS |
99 mg/dL |
| HbA1c |
6% |
| C-peptide |
0.5 - 2.0 ng/mL |
| Albumin Excretion Rate |
30 mg/24Hrs |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/07/2021 |
| Date of Study Completion (India) |
31/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Doi:10.7860/JCDR/2022/51963.16008
Doi:10.54905/disssi/v26i128/ms396e2427 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Sensory symptoms and deficits are frequently observed in diabetic polyneuropathy, but motor deficits are more difficult to recognize or often neglected. As a part of a rehabilitation team, we observed altered muscle strength in T2DM in relation to neuropathy. This study was conducted to find the relationship of muscle strength in diabetes, subjects were characterized by microvascular complications and biochemical measurements. By using standard laboratory methods, biochemical measurements were taken, which included Fasting Blood Sugar level, HbA1c, Serum Creatine, Serum Insulin, C-peptide & Albumin excretion rate. The retinal status of the diabetic subjects was classified as normal, non-proliferative and proliferative retinopathy, renal status classified as incipient & overt nephropathy, and neuropathy as asymptomatic & symptomatic by ophthalmologist, nephrologist & neurologist respectively. |