| CTRI Number |
CTRI/2024/06/069134 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between Six-Minute Walk Distance and Walking Performance Questionnaire in Tobacco and Non-tobacco Users |
|
Scientific Title of Study
|
Comparison of Six-Minute Walk Distance and Walking Impairment Questionnaire in Tobacco and Non-tobacco Users with Intermittent Claudication |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushama Bhandare |
| Designation |
Assistant Professor |
| Affiliation |
Seth G S Medical College and KEMH |
| Address |
402, Physiotherapy School and Centre, Seth GSMC and KEMH, OC Building, E Borges Road, Opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820219984 |
| Fax |
|
| Email |
sushamab7@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sushama Bhandare |
| Designation |
Assistant Professor |
| Affiliation |
Seth G S Medical College and KEMH |
| Address |
402, Physiotherapy School and Centre, Seth GSMC and KEMH, OC Building, E Borges Road, Opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820219984 |
| Fax |
|
| Email |
sushamab7@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saloni Rangari |
| Designation |
P G Student |
| Affiliation |
Seth G S Medical College and KEMH |
| Address |
402, Physiotherapy School and Centre, Seth GSMC and KEMH, OC Building, E Borges Road, Opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7262849615 |
| Fax |
|
| Email |
salonibrangari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth G S Medical College & KEM Hospital Parel East Mumbai 12 |
|
|
Primary Sponsor
|
| Name |
Physiotherapy School and Centre Seth G S Medical College and KEMH |
| Address |
Physiotherapy School and Centre, Department of Cardiology Seth G S Medical College Opposite Tata Hospital Parel East Mumbai 12 |
| Type of Sponsor |
Government medical college |
|
|
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 Sushama Bhandare |
Physiotherapy School and Centre Seth G S Medical College |
Parel East KEM Hospital, Acharya Dhonde Marg, Parel East, Mumbai-12
Mumbai
MAHARASHTRA |
9820219984
sushamab7@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth G S Medical Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I778||Other specified disorders of arteries and arterioles, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Smokers, tobacco chewers or tobacco in any form
2. Tobacco users with Intermittent Claudication
3. Non-tobacco users with Intermittent Claudication
4. ABI (less than 0.9)
5. Claudication Stage II (Fontaine Classification)
6. Doppler showing arterial picture
|
|
| ExclusionCriteria |
| Details |
1. Anybody with Lower Limb MSK disorders or any cardiac or neuro illness
2. People with Diabetic foot and neuropathy
3. Neurogenic claudication
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Six-Minute Walk Test
2. Walking Impairment Questionnaire |
Once at baseline |
|
|
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)
|
20/06/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Tobacco has detrimental effects on human body. Tobacco contributes to the onset of Peripheral Arterial Disease which brings about changes such as – Atherosclerosis, Inflammation, Vasoconstriction of the arteries, reducing the blood supply to the tissues and impairs wound healing. There is evidence which shows that tobacco affects ambulatory function and exercise capacity in patients with Intermittent Claudication. Even in the absence of symptoms, people with PAD had reduced levels of physical activity, worse walking endurance, slower walking speeds, and worse balance than people without PAD. Greater functional impairment is correlated with PAD severity. A low-cost way to test the ability to walk is the Six-minute walk test. And to quantify the ambulatory function, Walking Impairment Questionnaire was designed. This present study aims to compare six-minute walk distance and Walking Impairment Questionnaire score in tobacco and non-tobacco users with Intermittent Claudication. A comparative, observational study will be conducted. Six-minute walk test will be conducted. The distance walked by the patient in six minutes will be noted. Walking Impairment Questionnaire will be filled by the participants. The “walking distance,†“walking speed†and “stair climbing†scores will be noted according to the Questionnaire filled by the patients. The distance walked by the patient in Six-Minute Walk test and the score of the Walking Impairment Questionnaire in tobacco and non-tobacco users with Intermittent Claudication will be compared to understand the walking ability of the patients. |