The Comparison of the 3 Minutes Ramp Walk Test With 6 Minutes Walk Test in Stable Patients After Valve Replacement

• Conditions: Abnormality of Aortic Valve; Prosthetic Replacement of Mitral Valve

• Registration Number: NCT02279238
• Lead Sponsor: PSG Institute of Medical Science and Research

Brief Summary

In view of assessing the uphill walking capacity and to provide a functional stress test with better sensitivity the investigators need a short term functional stress test over the gold standard six minute walk test....

To demonstrate the significance of 3 minutes ramp walk test over 6 minutes walk test as a functional stress test.

The investigators hypothesize that the investigators three minutes ramp walk test (3MRWT) will be superior to the existing six minutes level walk test (6MWT) in the measurement of functional capacity of post valve replacement patients.

Detailed Description

The patients who have undergone valve replacement surgeries face difficulty in their functional activities especially during climbing stairs, walking uphill.

The six minute level walk test has been a gold standard in the assessment of functional capacity in cardio respiratory conditions like, coronary heart diseases , valvular heart diseases, chronic respiratory illness.

Moreover, six minute walk test has been framed to assess the functional capacity in level walking.so far, no test have been developed to assess the functional capacity of the patients during uphill walking and stair climbing.

Though ramp walking ( uphill walking) can be trained using treadmill, it is not feasible for the indian patients as they are not familiar in the treadmill and their fear may also show variation in the functional assessment.

Hence this study has been proposed..

Study Timeline

• Study Start: 2013-11
• Status Verified: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-28
• Last Update Submitted: 2014-10-28
• Study First Posted: 2014-10-31
• Last Update Posted: 2014-10-31
• Primary Completion: 2015-03
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Both genders
• 30 to 65 years
• Patient in step down unit(5th post operative day)
• Aortic and Mitral valve replaced patients

Exclusion Criteria

• Vitally unstable patients, [pyretic, abnormal BP, SpO₂, X-Ray and pain]
• Any arrthymia
• Orthopaedically disabled patients
• Neurologically impaired patients
• Patients with psychologically impaired

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The distance walked during the test by the participants	6 minute level walk & 3 minute Ramp walk	The variables to be correlated are Distance walked \[in meters\], heart rate responses, , Saturation Responses

Secondary Outcome Measures

Name	Time	Method
SpO2 % before and after test	6 minute level walk& 3minute Ramp walk
blood pressure before and after test	6 minute level walk& 3minute Ramp walk
Heart rate before and after test	6 minute level walk& 3minute Ramp walk

Trial Locations

Locations (1)

PSG Hospitals; 🇮🇳 Coimbatore, Tamilnadu, India