The aim of this study is to generate more reliable outcome values as basis for physiotherapeutic treatment. Therefore, we need to determine the usability of the modified test from Eindhoven, not only in healthy but also in subjects with MSPDs.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Musculo-skeletale pijnklachten (oa chronische lage rugpijn, fibromyalgie)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Group of healthy subjects: difference of maximal volume oxygen uptake (VO2 max
in mL/kg lean body mass/min (mL/kg LBM.min-1)) between the two test methods in
percentages. Golden standard is the regular Åstrand test.
MSPD group: the amount of drop-outs. If possible (regarding the amount of
drop-outs and the study power), the difference of maximal volume oxygen uptake
between the two test methods in percentages is also a main study parameter in
this group. Than also the regular Åstrand test is seen as the golden standard.
Secondary outcome
Healthy group: the amount of drop-outs
Both groups: general self-efficacy, pain (expected maximal pain during the
Åstrand test and actual experienced pain during the Åstrand test), perceived
exertion, and an estimation of the chance of completing the Åstrand test.
Background summary
Physical fitness level is largely determined by the aerobic capacity. In the
rehabilitation setting aerobic capacity tests are frequently performed to
adjust the physiotherapeutic treatment to the individual aerobic capacity, and
to evaluate the process. In rehabilitation centre Blixembosch this is a
standard assessment in people with Musculo-Skeletal Pain Disorders (MSPDs).
Aerobic capacity is determined by measuring maximum oxygen uptake (VO2 max).
For this, generally a submaximal effort test is used: the Åstrand bicycle test.
In Blixembosch this test appears to be too demanding for many pain patients. As
a result, they can not complete the test. In this centre a modified Åstrand
test is developed, which seems easier to accomplish for the patients. However,
usability of this test has not been determined yet.
Study objective
The aim of this study is to generate more reliable outcome values as basis for
physiotherapeutic treatment. Therefore, we need to determine the usability of
the modified test from Eindhoven, not only in healthy but also in subjects with
MSPDs. Obtained VO2 max values of the modified Åstrand test will be compared to
the VO2 max values of the regular Åstrand test.
Study design
First, the study has to be approved by the METC. 30 subjects with MSPD and 30
healthy subjects - who meet the in- and exclusion criteria and gave written
informed consent for participation - will perform both a regular and a modified
Åstrand submaximal bicycle test (cross over design). Several questionnaires
will be completed regarding activity level, pain disability, self-efficacy,
pain and perceived exertion.
The VO2 max values of both tests will be calculated and compared in each
participant. A pared sample t-test will be performed to determine whether the
outcomes match enough to call the test useful.
Study burden and risks
The risks for sub-maximal testing are low (see E9).
Toledolaan 2
Postbus 1355, 5602 BJ Eindhoven
Nederland
Toledolaan 2
Postbus 1355, 5602 BJ Eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
MSPD-group:
- The subjects need to be diagnosed with MSPD by their General Practitioner or Medical specialist. In this study, it only applies to specific and a-specific low back pain, specific and a-specific pelvic or lower extremity pain, chronic pain syndromes and fibromyalgia. The rehabilitation physician indicated that treatment was suitable to diminish the limitations resulting from this MSPD. At the moment of inclusion, the subject with MSPDs has to be under supervision in Rehabilitation Centre Blixembosch, Eindhoven. ;General inclusion criteria:
- Age between 30 and 65 years
- Ability to walk 100 meters without interruption
Exclusion criteria
- Not able to read and speak sufficient Dutch (because of the questionnaires)
- The use of β-blockers
- Suffering from neurological, metabolic, cardiovascular or pulmonary disease making aerobic capacity testing impossible
- Major psychiatric conditions
- Pregnancy
- Other medical co-morbidity which impede intensive aerobic capacity testing
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL17656.022.07 |