The Comparison of the 3 Minutes Ramp Walk Test With 6 Minutes Walk Test in Stable Patients After Valve Replacement
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|ClinicalTrials.gov Identifier: NCT02279238|
Recruitment Status : Unknown
Verified October 2014 by arumugam manivel, PSG Institute of Medical Science and Research.
Recruitment status was: Recruiting
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
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.
|Condition or disease||Intervention/treatment|
|Prosthetic Replacement of Mitral Valve Abnormality of Aortic Valve||Procedure: cardiac rehabilitation|
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 Type :||Observational|
|Estimated Enrollment :||45 participants|
|Official Title:||The Comparison of the 3 Minutes Ramp Walk Test With 6 Minutes Walk Test in Stable Patients After Valve Replacement|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||October 2015|
- Procedure: cardiac rehabilitation
It is a cross over study in which the participants are assigned for two test simultaneously with washout time of 6 hrs . 5th POD patients are randomly assigned to either 6 minute walk test or 3 minute ramp walk test as first test with 6 hours of rest [Washout time] in between the two test.
6 MWT : The patient is instructed to walk for a period of 6 minute on a 30 meters Hallway with its extent being demarcated by the placement of 2 cones at the extremes of the Hall.
3 MRWT : The patient is instructed to walk for a period of 3 minute on a Ramp with an elevation of 30 degree and length of 20 meters with its extent being demarcated by the placement of 2 cones at the extremes of the ramp.
The data of [HR, SPO2, PSG RPE scale, Distance walked, BP] the participants are collected before, during and after the completion of each lap [according to American Thoracic Society [ATS] protocol].
- The distance walked during the test by the participants [ Time Frame: 6 minute level walk & 3 minute Ramp walk ]The variables to be correlated are Distance walked [in meters], heart rate responses, , Saturation Responses
- blood pressure before and after test [ Time Frame: 6 minute level walk& 3minute Ramp walk ]
- Heart rate before and after test [ Time Frame: 6 minute level walk& 3minute Ramp walk ]
- SpO2 % before and after test [ Time Frame: 6 minute level walk& 3minute Ramp walk ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279238
|Contact: manivel arumugam, MPTemail@example.com|
|Contact: mahesh ramaraja, MPT||0422-2570170 ext firstname.lastname@example.org|
|Coimbatore, Tamilnadu, India, 641004|
|Contact: manivel arumugam, MPT +919994672033 email@example.com|
|Contact: Mahesh Ramaraja, MPT 0422-2570170 ext 5871 firstname.lastname@example.org|
|Principal Investigator: manivel arumugam, MPT|
|Sub-Investigator: mahesh Ramaraja, MPT|
|Sub-Investigator: Murugesan PR, MS,Mch,DNB|
|Study Chair:||murugesan PR, MS,Mch,DNB||PSG Institute of Medical Science and Research|
|Principal Investigator:||manivel arumugam, MPT||PSG Institute of Medical Science and Research|