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

Validity, reproducibility and responsiveness of the two minute step test in frail cardiac patients - Validity 2 minute step test in frail cardiac patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49400

Enrollment

Registered

2020-04-23

Start date

2021-09-21

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aorta Valve Replacement frailty

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Unstable ischemic heart disease Inability or any contra-indication to perform physical exercise Life expectancy

Design outcomes

Primary

Measure	Time frame
Validity of 2MST: Intraclass correlation coefficient (ICC) between VO2-peak CPET and VO2-peak 2MST Reproducibility of 2MST: ICC between NoS T1 and NoS T2, and between VO2-peak T1 and VO2-peak T2 Responsiveness of 2MST: minimal clinically important difference (MCID) for NoS T3.	—

Secondary

Measure	Time frame
quality of life (KVL-H), level of daily activities (KATz-ADL), physical functioning (Short Physical Performance Battery), metabolic equivalents level (Specific Activity Scale), self perceived effect. Possible associations with performance on exercise testing: for sarcopenia: fat-free mass (Bio Impedance Assessment and CT-scan), grip strength (JAMAR), risk of malnutrition (SNAQ); for cardiac anxiety: CAQ-DV, rate of perceived exertion (BORG-RPE); for comorbidity (Charlson comorbidity index); and for frailty (Edmonton frailty scale).	—

Measure

Time frame

quality of life (KVL-H), level of daily activities (KATz-ADL), physical functioning (Short Physical Performance Battery), metabolic equivalents level (Specific Activity Scale), self perceived effect. Possible associations with performance on exercise testing: for sarcopenia: fat-free mass (Bio Impedance Assessment and CT-scan), grip strength (JAMAR), risk of malnutrition (SNAQ); for cardiac anxiety: CAQ-DV, rate of perceived exertion (BORG-RPE); for comorbidity (Charlson comorbidity index); and for frailty (Edmonton frailty scale).

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Countries

Netherlands

Outcome results