1. Studying validity of the 2MST in comparison with CPET2. Studying reproducibility of the 2MST by test-retest3. Studying responsiveness of the 2MST to changes in physical fitness
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Cardiac rehabilitation (CR) is considered standard of care after hospital
admission or intervention for cardiac disease, and is preceded by exercise
testing. The objective of exercise testing is to assess the safety of exercise
and to assess baseline fitness level of patients. The baseline fitness level is
used for personalising exercise prescription and evaluation of changes in
fitness during CR. The gold standard for exercise testing is a lab-based
cardiopulmonary exercise test (CPET). However, for frail patients, CPET is
burdensome and complex. A less complex, non lab-based, preferentially
home-based exercise test is potentially better suited to frail patients with
cardiac disease. Field-tests such as the six-minute walk test and shuttle walk
test have been suggested as an alternative, but are often not feasible in the
home setting. The two-minute step test (2MST), which uses the number of steps
to assess maximal exercise capacity, has been shown to be feasible in the home
setting in elderly patients. However, the 2MST has not been validated in frail
patients with cardiac disease and responsiveness to change is unknown.
Study objective
1. Studying validity of the 2MST in comparison with CPET
2. Studying reproducibility of the 2MST by test-retest
3. Studying responsiveness of the 2MST to changes in physical fitness
Study design
This is an observational validation study in which we will compare the
performance of the two minute step test (2MST) to the gold standard in exercise
testing, i.e. a cardiopulmonary exercise test with gas exchange measurement
(CPET).
Subjects will be included during hospital admission after the TAVI procedure.
Subjects will be tested on three occasions, see figure 1. Initially, the
subjects will perform a CPET two to three weeks after dismissal from the
hospital. This is part of the usual intake for cardiac rehabilitation.
Additionally, after an hour of rest, they will perform the first step test
(2MST-1) with gas-exchange measurement. For reproducibility of the test, within
two to five days, a second step test (2MST-2) will be performed at home
together with mobile gas exchange measurement to assess VO2-peak. Finally, to
test responsiveness, at the end of their regular cardiac rehabilitation, a
third step test (2MST-3) will be performed together with mobile gas exchange
measurement to assess VO2-peak.
Study burden and risks
The 2MST is a submaximal exercise test. Performance of comparable submaximal
exercise tests (eg. 6-minute walk test) is part of standard care in CR and
considered safe. However musculoskeletal complaints have been reported after
performance of exercise testing. The 2MST brings no additional risk for
patients who are indicated for cardiac rehabilitation.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL70174.018.19 |