Clinical trial NCT02279238: The Comparison of the 3 Minutes Ramp Walk Test With 6 Minutes Walk Test in Stable Patients After Valve Replacement
Official title: The Comparison of the 3 Minutes Ramp Walk Test With 6 Minutes Walk Test in Stable Patients After Valve Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prosthetic Replacement of Mitral Valve
Abnormality of Aortic Valve
Lead sponsor: PSG Institute of Medical Science and Research
Sponsor class: OTHER
Collaborators: name: PSG College of Physiotherapy
First posted: 2014-10-31
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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

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.

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..

Eligibility 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

Primary outcomes:
measure: The distance walked during the test by the participants
timeFrame: 6 minute level walk & 3 minute Ramp walk
Secondary outcomes:
measure: blood pressure before and after test
timeFrame: 6 minute level walk& 3minute Ramp walk
measure: Heart rate before and after test
timeFrame: 6 minute level walk& 3minute Ramp walk
measure: SpO2 % before and after test
timeFrame: 6 minute level walk& 3minute Ramp walk
Other outcomes:
Locations:
city: Coimbatore
country: India
facility: PSG Hospitals
state: Tamilnadu
Study officials:
affiliation: PSG Institute of Medical Science and Research
name: murugesan PR, MS,Mch,DNB
role: STUDY_CHAIR
affiliation: PSG Institute of Medical Science and Research
name: manivel arumugam, MPT
role: PRINCIPAL_INVESTIGATOR
References: