Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
PSG College of Physiotherapy
Information provided by (Responsible Party):
arumugam manivel, 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.


Condition or disease Intervention/treatment
Prosthetic Replacement of Mitral Valve Abnormality of Aortic Valve Procedure: cardiac rehabilitation

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..

Layout table for study information
Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
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

Intervention Details:
  • 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].



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. blood pressure before and after test [ Time Frame: 6 minute level walk& 3minute Ramp walk ]
  2. Heart rate before and after test [ Time Frame: 6 minute level walk& 3minute Ramp walk ]
  3. SpO2 % before and after test [ Time Frame: 6 minute level walk& 3minute Ramp walk ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
To find a smallest difference of 70% and a minimal correlation of 40%(r=0.4)between two test , walk distance , vital responses at level of significance of 95% and power of the study 90%, we needed at least 45 patients.to allow for drop outs and missing values,50 patients will be included
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: manivel arumugam, MPT +919994672033 arumani_005@yahoo.co.in
Contact: mahesh ramaraja, MPT 0422-2570170 ext 5871 maheshrehab@rediffmail.com

Locations
Layout table for location information
India
PSG Hospitals Recruiting
Coimbatore, Tamilnadu, India, 641004
Contact: manivel arumugam, MPT    +919994672033    arumani_005@yahoo.co.in   
Contact: Mahesh Ramaraja, MPT    0422-2570170 ext 5871    maheshrehab@rediffmail.com   
Principal Investigator: manivel arumugam, MPT         
Sub-Investigator: mahesh Ramaraja, MPT         
Sub-Investigator: Murugesan PR, MS,Mch,DNB         
Sponsors and Collaborators
PSG Institute of Medical Science and Research
PSG College of Physiotherapy
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: arumugam manivel, Mr. Manivel arumugam, PSG Institute of Medical Science and Research
ClinicalTrials.gov Identifier: NCT02279238    
Other Study ID Numbers: 13/208
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Congenital Abnormalities