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Clinical Trials/CTRI/2024/06/069134
CTRI/2024/06/069134RecruitingNot Applicable

Comparison of Six-Minute Walk Distance and Walking Impairment Questionnaire in Tobacco and Non-tobacco Users with Intermittent Claudication

Physiotherapy School and Centre Seth G S Medical College and KEMH1 site in 1 country60 target enrollmentStarted: June 20, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
1.Six-Minute Walk Test

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
45.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Smokers, tobacco chewers or tobacco in any form
  • •Tobacco users with Intermittent Claudication
  • •Non-tobacco users with Intermittent Claudication
  • •ABI (less than 0.9)
  • •Claudication Stage II (Fontaine Classification)
  • •Doppler showing arterial picture.

Exclusion Criteria

  • •Anybody with Lower Limb MSK disorders or any cardiac or neuro illness
  • •People with Diabetic foot and neuropathy
  • •Neurogenic claudication.

Outcomes

Primary Outcomes

1.Six-Minute Walk Test

Time Frame: Once at baseline

2. Walking Impairment Questionnaire

Time Frame: Once at baseline

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Physiotherapy School and Centre Seth G S Medical College and KEMH
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Sushama Bhandare

Seth G S Medical College and KEMH

Study Sites (1)

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