Prosthetic Replacement of Mitral ValveNCT02279238
The Comparison of the 3 Minutes Ramp Walk Test With 6 Minutes Walk Test in Stable Patients After Valve Replacement
An observational study of Prosthetic Replacement of Mitral Valve and Abnormality of Aortic Valve, run by PSG Institute of Medical Science and Research at 1 site in India.
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.... Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthetic Replacement of Mitral Valve, Abnormality of Aortic Valve
- What is being tested?
- cardiac rehabilitation
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2013to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Both genders
- 30 to 65 years
- Patient in step down unit(5th post operative day)
- Aortic and Mitral valve replaced patients
Who cannot join
- Vitally unstable patients, [pyretic, abnormal BP, SpO₂, X-Ray and pain]
- Any arrthymia
- Orthopaedically disabled patients
- Neurologically impaired patients
- Patients with psychologically impaired
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PSG Hospitals
Coimbatore, Tamil Nadu, 641004
manivel arumugam, MPT, +919994672033, arumani_005@yahoo.co.in
Mahesh Ramaraja, MPT, 0422-2570170 ext. 5871, maheshrehab@rediffmail.com
About this study
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.
Read the 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..
- Being tested
- cardiac rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac rehabilitationProcedure or surgery
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].
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance walked during the test by the participants
The variables to be correlated are Distance walked [in meters], heart rate responses, , Saturation Responses
Measured: 6 minute level walk & 3 minute Ramp walk
Secondary outcomes (3)
blood pressure before and after test
Measured: 6 minute level walk& 3minute Ramp walk
Heart rate before and after test
Measured: 6 minute level walk& 3minute Ramp walk
SpO2 % before and after test
Measured: 6 minute level walk& 3minute Ramp walk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Replacement of Mitral ValveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PSG Institute of Medical Science and Research
- Sponsor type
- University, hospital or other
- Collaborators
- PSG College of Physiotherapy
- Responsible party
- Principal investigator, arumugam manivel, PSG Institute of Medical Science and Research
- Investigators
- murugesan PR, MS,Mch,DNB, Study chair, PSG Institute of Medical Science and Researchmanivel arumugam, MPT, Principal investigator, PSG Institute of Medical Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279238
- Sponsor's protocol ID
- 13/208
- Status last verified
- Oct 2014
- First submitted
- 14 Oct 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the 3 Minutes Ramp Walk Test With 6 Minutes Walk Test in Stable Patients After Valve Replacement
- ClinicalTrials.gov ID
- NCT02279238
- Acronym / sponsor ID
- 13/208
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- PSG Institute of Medical Science and ResearchUniversity, hospital or other
- Collaborators
- PSG College of Physiotherapy
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Both genders
- 30 to 65 years
- Patient in step down unit(5th post operative day)
- Aortic and Mitral valve replaced patients
Key exclusion criteria (5 listed)
- Vitally unstable patients, [pyretic, abnormal BP, SpO₂, X-Ray and pain]
- Any arrthymia
- Orthopaedically disabled patients
- Neurologically impaired patients
- Patients with psychologically impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac rehabilitationIt 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]. | Procedure or surgery | – |
Primary outcome
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
3 secondary outcomes
blood pressure before and after test
Time frame: 6 minute level walk& 3minute Ramp walk
Heart rate before and after test
Time frame: 6 minute level walk& 3minute Ramp walk
SpO2 % before and after test
Time frame: 6 minute level walk& 3minute Ramp walk
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
murugesan PR, MS,Mch,DNB study chair
PSG Institute of Medical Science and Research
manivel arumugam, MPT principal investigator
PSG Institute of Medical Science and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthetic Replacement of Mitral Valve and Abnormality of Aortic Valve, run by PSG Institute of Medical Science and Research at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact manivel arumugam, MPT (+919994672033, arumani_005@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distance walked during the test by the participants (time frame: 6 minute level walk & 3 minute Ramp walk). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.