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Validity, reproducibility and responsiveness of the two minute step test in frail cardiac patients

Recruiting
Conditions
Aorta Valve Replacement
frailty
10046973
Registration Number
NL-OMON49400
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
68
Inclusion Criteria

Undergo a Transcatheter Aortic Valve Implantation (TAVI) in the AUMC
Age >= 70 years
Able to walk prior to TAVI (immobility due to aortic stenosis excepted)
Absence of any comorbid disease leading to inability to walk.
Eligible and motivated to participate in cardiac rehabilitation

Exclusion Criteria

Unstable ischemic heart disease
Inability or any contra-indication to perform physical exercise
Life expectancy < 6 months

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Validity of 2MST: Intraclass correlation coefficient (ICC) between VO2-peak<br /><br>CPET and VO2-peak 2MST<br /><br><br /><br>Reproducibility of 2MST: ICC between NoS T1 and NoS T2, and between VO2-peak T1<br /><br>and VO2-peak T2<br /><br><br /><br>Responsiveness of 2MST: minimal clinically important difference (MCID) for NoS<br /><br>T3. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>quality of life (KVL-H), level of daily activities (KATz-ADL), physical<br /><br>functioning (Short Physical Performance Battery), metabolic equivalents level<br /><br>(Specific Activity Scale), self perceived effect. Possible associations with<br /><br>performance on exercise testing: for sarcopenia: fat-free mass (Bio Impedance<br /><br>Assessment and CT-scan), grip strength (JAMAR), risk of malnutrition (SNAQ);<br /><br>for cardiac anxiety: CAQ-DV, rate of perceived exertion (BORG-RPE); for<br /><br>comorbidity (Charlson comorbidity index); and for frailty (Edmonton frailty<br /><br>scale). </p><br>
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