The objective in this study is threefold. First, to test the test-retest reproducibility of the 6- minutes walk-run test. Secondly, to test the responsiveness and to compare this with the 6- minutes walk test. Further, to test the construct validity…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the 6-minutes walk-run test.
Secondary outcome
Other study parameters are the 6-minute walk test, the Functional reach test
and the VO2max test.
Background summary
Patients with a heart disease can participate in a rehabilitation program in
the MUMC+. Before rehabilitation starts a 6- minutes walk test which assesses
the exercise tolerance level is performed to have baseline measurements. These
are used to evaluate the progress and to divide patients into rehabilitation
groups. The problem is that this test is not that responsive in (less severe)
patients. Therefore a new test is designed, called the 6-minutes walk-run test.
In this test, with the same duration as the 6- minutes walk test, also running
is allowed.
Study objective
The objective in this study is threefold. First, to test the test-retest
reproducibility of the 6- minutes walk-run test. Secondly, to test the
responsiveness and to compare this with the 6- minutes walk test. Further, to
test the construct validity of the 6-minutes walk-run test in a convergent way
with the VO2max and in a divergent way with the Functional Reach and compare
this with the results of the 6-minutes walk test.
Study design
The study is divided into two parts. In the first part the test-retest
reproducibility and the responsiveness is investigated in a group of patients
with a coronary heart disease. In the second part, the test-retest
reproducibility, the responsiveness and the construct validity is tested in a
population of heart failure patients. Both study parts have a prospective
cohort design, with a cross sectional part to investigate the test-retest
reproducibility.
Study burden and risks
During normal rehabilitation, the patients have several tests and activities
which equal the exertion in this tests. Secondly, there is no use of invasive
interventions. Thirdly, the patients are checked if they are in shape to
fulfill the rehabilitation program. Therefore, the risks faced by the patients
are no greater than the risks they face during normal rehabilitation.
Furthermore, the study participants have the same rehabilitation program as
normal.
The additional burden placed on the patients, will be the extra time with the
investigator before the rehabilitation. The tests will be on the same day and
before the rehabilitation, with this the burden will be as minimal as possible.
P. debeyelaan 25
6229 HX Maastricht
Nederland
P. debeyelaan 25
6229 HX Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
•Patients who are diagnosed by an medical doctor with a heart disease: heart infarction and/or heart surgery (bypass and/or valve reconstruction) or heart failure
•Patients who are willing and able to participate in a rehabilitation program
•Minimal 18 years
Exclusion criteria
•Patients with other heart diseases (e.g. rhythm problems, pace maker of ICD implantation) not accompanied by hearth infarction or treated with heart surgery
•Patient with walking disorders (neurologic or orthopaedic).
•People without a need for rehabilitation
•Resting blood pressure >180/100 mm/Hg
•Resting heart frequency > 120 bpm
Design
Recruitment
Medical products/devices used
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 | NL29285.068.09 |
| Other | nog niet bekend |