NCT02279238

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

1.3 years

First QC Date

October 14, 2014

Last Update Submit

October 28, 2014

Conditions

Prosthetic Replacement of Mitral ValveAbnormality of Aortic Valve

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Interventions

cardiac rehabilitationPROCEDURE

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\].

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSG Hospitals

Coimbatore, Tamil Nadu, 641004, India

RECRUITING

MeSH Terms

Interventions

Cardiac Rehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • murugesan PR, MS,Mch,DNB

    PSG Institute of Medical Science and Research

    STUDY CHAIR

  • manivel arumugam, MPT

    PSG Institute of Medical Science and Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

manivel arumugam, MPT

CONTACT

+919994672033arumani_005@yahoo.co.in

mahesh ramaraja, MPT

CONTACT

0422-2570170maheshrehab@rediffmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr. Manivel arumugam

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 31, 2014

Study Start

November 1, 2013

Primary Completion

March 1, 2015

Study Completion

October 1, 2015

Last Updated

October 31, 2014

Record last verified: 2014-10

Locations

IN(1)