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

Prosthetic Replacement of Mitral Valve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02279238
• Other study ID #: 13/208
• Status: Unknown status
• Phase: N/A
• First received: October 14, 2014
• Last updated: October 28, 2014
• Start date: November 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2014
• Source: PSG Institute of Medical Science and Research
• Contact: manivel arumugam, MPT
• Phone: +919994672033
• Email: arumani_005[@]yahoo.co.in
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 45
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abnormality of Aortic Valve
• Prosthetic Replacement of Mitral Valve

Intervention

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].

Locations

Country	Name	City	State
India	PSG Hospitals	Coimbatore	Tamilnadu

Sponsors (2)

Lead Sponsor	Collaborator
PSG Institute of Medical Science and Research	PSG College of Physiotherapy

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The distance walked during the test by the participants	The variables to be correlated are Distance walked [in meters], heart rate responses, , Saturation Responses	6 minute level walk & 3 minute Ramp walk
Secondary	blood pressure before and after test		6 minute level walk& 3minute Ramp walk
Secondary	Heart rate before and after test		6 minute level walk& 3minute Ramp walk
Secondary	SpO2 % before and after test		6 minute level walk& 3minute Ramp walk