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

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.

Study Overview

• Status: Unknown
• Conditions: Prosthetic Replacement of Mitral Valve; Abnormality of Aortic Valve
• Intervention / Treatment: 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..

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: manivel arumugam, MPT; Phone Number: +919994672033; Email: arumani_005@yahoo.co.in
• Study Contact Backup: Name: Mahesh Ramaraja, MPT; Phone Number: 5871 0422-2570170; Email: maheshrehab@rediffmail.com

Study Locations

• India
  • Tamilnadu
    • Coimbatore, Tamilnadu, India, 641004
      • Recruiting
      • PSG Hospitals
      • Contact: manivel arumugam, MPT; Phone Number: +919994672033; Email: arumani_005@yahoo.co.in
      • Contact: Mahesh Ramaraja, MPT; Phone Number: 5871 0422-2570170; Email: maheshrehab@rediffmail.com
      • Principal Investigator: manivel arumugam, MPT
      • Sub-Investigator: mahesh Ramaraja, MPT
      • Sub-Investigator: Murugesan PR, MS,Mch,DNB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
SpO2 % before and after test	6 minute level walk& 3minute Ramp walk

Collaborators and Investigators

• Sponsor: PSG Institute of Medical Science and Research
• Collaborators: PSG College of Physiotherapy
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Estimate): October 31, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 13/208