| CTRI Number |
CTRI/2025/07/091904 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Study of Calf Muscle Strength and Endurance in Smokers and Non-Smokers
|
|
Scientific Title of Study
|
Comparison of Calf Muscle Strength and Endurance among smokers and Non Smokers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saisha Kamat |
| Designation |
Postgraduate student |
| Affiliation |
SDM college of Physiotherapy |
| Address |
OPD number 5 Orthopedic Physiotherapy Department,SDM College Of Physiotherapy SDM College Of Medical Sciences And Hospital Manjushree Nagar Sattur Dharwad Karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
07666200296 |
| Fax |
|
| Email |
saishakamat25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saisha Kamat |
| Designation |
Postgraduate student |
| Affiliation |
SDM college of Physiotherapy |
| Address |
OPD number 5 Orthopedic Physiotherapy Department,SDM College Of Physiotherapy SDM College Of Medical Sciences And Hospital Manjushree Nagar Sattur Dharwad Karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
7666200296 |
| Fax |
|
| Email |
saishakamat25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saisha Kamat |
| Designation |
Postgraduate student |
| Affiliation |
SDM college of Physiotherapy |
| Address |
OPD number 5 Orthopedic Physiotherapy Department,SDM College Of Physiotherapy SDM College Of Medical Sciences And Hospital Manjushree Nagar Sattur Dharwad Karnataka 580009
KARNATAKA
580009
India |
| Phone |
07666200296 |
| Fax |
|
| Email |
saishakamat25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saisha kamat |
| Address |
OPD number 5 Orthopedic Physiotherapy Department,SDM College Of Physiotherapy SDM College Of Medical Sciences And Hospital Manjushree Nagar Sattur Dharwad Karnataka 580009 |
| 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 |
| Saisha Kamat |
SDM College of Medical Sciences and Hospital |
OPD number 5 Orthopedic Physiotherapy Department,SDM College Of Physiotherapy SDM College Of Medical Sciences And Hospital Manjushree Nagar Sattur Dharwad Karnataka 580009
Dharwad
KARNATAKA |
7666200296
saishakamat25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
smokers and non smokers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Age between 20 and 50 years.
2) For smokers: minimum of 1 year of daily smoking with at least 5 pack-years history.
3) For non-smokers: no history of smoking or passive smoking.
4) Ability to perform physical tests without aid.
5) BMI between 18.5–29.9 kg/m² to minimize confounding from obesity or malnutrition.
Willingness to participate with informed consent.
|
|
| ExclusionCriteria |
| Details |
1) Diagnosed chronic respiratory illness (COPD, asthma, bronchiectasis, etc.) and PVD.
2) History of cardiovascular or neuromuscular disorders affecting lower limb function.
3) Recent lower limb injury or surgery (less than 6 months).
4) Diabetes mellitus or other endocrine/metabolic disorders affecting muscle function.
5) Participation in structured lower limb resistance training in the past 3 months.
6) Pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heel raise test |
until exhaustion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/08/2025 |
| 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="1"
Months="1"
Days="1" |
|
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 observational, cross-sectional study aims to compare calf muscle strength and endurance between smokers and non-smokers aged 20–50 years using the Single-Leg Heel Raise Test. Conducted at SDM College of Physiotherapy, Dharwad, the study will include 60 participants divided into two groups: smokers (with at least 1 year of daily smoking and a minimum of 5 pack-years) and non-smokers (no history of smoking or passive exposure). Individuals with respiratory, neuromuscular, cardiovascular, metabolic disorders, or recent lower limb injuries will be excluded. The primary outcome is the number of correct heel raises performed until the participant is exhausted. The test will be stopped when participants are unable to (1) raise the stance heel from the incline or repeat a full heel-rise cycle, (2) keep the pace, knee angle, or trunk position constant, or (3) use the wall to help with performance and rely on fingertip support for balance. Secondary analysis will explore correlations between smoking exposure (duration, intensity, pack-years) and muscle function. Data will be analyzed using independent t-tests and correlation statistics, with ethical approval to be obtained prior to the study. |