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

NCT ID: NCT02279238

Last Updated: 2014-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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..

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prosthetic Replacement of Mitral Valve Abnormality of Aortic Valve

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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\].

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

PSG College of Physiotherapy

OTHER

Sponsor Role collaborator

PSG Institute of Medical Science and Research

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

arumugam manivel

Mr. Manivel arumugam

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

murugesan PR, MS,Mch,DNB

Role: STUDY_CHAIR

PSG Institute of Medical Science and Research

manivel arumugam, MPT

Role: PRINCIPAL_INVESTIGATOR

PSG Institute of Medical Science and Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

PSG Hospitals

Coimbatore, Tamil Nadu, India

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

India

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

manivel arumugam, MPT

Role: CONTACT

Phone: +919994672033

Email: [email protected]

mahesh ramaraja, MPT

Role: CONTACT

Phone: 0422-2570170

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

manivel arumugam, MPT

Role: primary

Mahesh Ramaraja, MPT

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13/208

Identifier Type: -

Identifier Source: org_study_id