| CTRI Number |
CTRI/2026/03/105174 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between calf muscle endurance and walking ability in individuals with type 2 Diabetes mellitus |
|
Scientific Title of Study
|
Correlation between calf muscle endurance and walking ability among individual with type 2 diabetes mellitus |
| Trial Acronym |
NOT APPLICABLE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Puvishwaran R |
| Designation |
Student |
| Affiliation |
SRM UNIVERSITY ,SRM COLLEGE OF PHYSIOTHERAPY,SRM IST ,KATTANKULATHUR |
| Address |
SRM KTR (CAMPUS)SRM COLLEGE OF PHYSIOTHERAPY,POTHERI
Chennai
TAMIL NADU
603203
India |
| Phone |
7418353181 |
| Fax |
|
| Email |
pp6305@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms GAYATHRI K |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRM KTR (CAMPUS)SRM COLLEGE OF PHYSIOTHERAPY |
| Address |
SRM KTR (CAMPUS)SRM COLLEGE OF PHYSIOTHERAPY,POTHERI
Chennai
TAMIL NADU
603203
India |
| Phone |
9840782628 |
| Fax |
|
| Email |
gayathrk1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms GAYATHRI K |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRM KTR (CAMPUS)SRM COLLEGE OF PHYSIOTHERAPY,KATTANKULATHUR |
| Address |
SRM KTR (CAMPUS)SRM COLLEGE OF PHYSIOTHERAPY,POTHERI, KATTANKULATHUR
Chennai
TAMIL NADU
603203
India |
| Phone |
9840782628 |
| Fax |
|
| Email |
gayathrk1@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PUVISHWARAN R |
GENERAL MEDICINE OP,GERNERAL SURGERY OP |
SRM MEDICAL HOSPITAL AND RESEARCH CENTRE, SRM IST ,KATTANKULATHUR
Chennai
TAMIL NADU |
7418353181
pp6305@srmist.edu.in |
| Puvishwaran R |
SRM MEDICAL HOSPITAL AND RESEARCH CENTRE |
SRM COLLEGE OF PHYSIOTHERAPY,SRM MEDICAL HOSPITAL AND RESEARCH CENTRE,SRM IST, KATTANKULARHUR
Chennai
TAMIL NADU |
7418353181
pp6305@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee -student |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetes type 2 |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with Type 2 Diabetes Mellitus for at least 1 year.
Age above 18 years.
Both male and female participants.
Willingness to participate and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
History of lower limb fractures, surgeries, or severe musculoskeletal disorders affecting mobility.
Presence of severe diabetic complications such as foot ulcers, advanced neuropathy, or peripheral vascular disease.
Cardiovascular or respiratory conditions that limit exercise tolerance.
Neurological disorders affecting gait or balance.
Participants currently involved in structured lower limb rehabilitation programs or endurance training.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Walking Impairement Questionnaire
Single Leg Heel Raise Test
Cadence
10 Meter Walk Test |
Walking Impairement -Questionnaire
Single Leg Heel Raise Test
Cadence - 1 Minutes
10 Meter Walk Test - 1 Minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="171"
Sample Size from India="171"
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)
|
15/03/2026 |
| 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="3"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims to determine the correlation between calf muscle endurance and walking ability among individuals with type 2 diabetes mellitus. Reduced muscle endurance and impaired walking ability are common in individuals with diabetes and may affect functional mobility and quality of life. This observational study will assess calf muscle endurance using a standardized functional test and walking ability using a validated questionnaire or performance based measure. The findings of this study may help in understanding the relationship between lower limb muscle endurance and walking function in individuals with type 2 diabetes mellitus. |