The primary objective is to investigate the measurement properties of isometric, isotonic and isokinetic protocol to assess quadriceps muscle endurance in patients with COPD. Our secondary objective is to determine the relationship between…
ID
Source
Brief title
Condition
- Muscle disorders
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reliability of the quadriceps isometric, isokinetic and isotonic endurance will
be assessed using a two-way random single measures ICC procedure. Munro*s
descriptors will be used to describe the degree of reliability: high, ICC =
0.70 to 0.89 and very high, 0.90 to 1.00. The limits of agreement between
measures taken on two days will be established using a Bland-Altman plot for
all measurements. The proportion of scores within 2 standard deviations of the
mean difference between test-retest values will be used to describe agreement.
In order to facilitate the clinical interpretation of reliability results, the
minimal detectable change (MDC) at 95% confidence level will be calculated. .
Secondary outcome
Bivariate, linear correlations will be evaluated using a Pearson correlation
coefficient for quadriceps isometric, isokinetic and isotonic endurance, and
SPPB scores. The strength of the relationship will be described using Munro*s
descriptive.
Background summary
Chronic obstructive pulmonary disease (COPD) is a leading cause of death
worldwide. It is estimated that 400000 patients suffer from this disease in the
Netherlands. Although COPD is primarily a disease of the respiratory system, a
common secondary consequence is quadriceps muscle dysfunction, that is, reduced
muscle strength and/or endurance. These have been associated with important
clinical outcomes including, but not limited to, reduced quality of life,
exercise intolerance, activities of daily life and hospitalization. Despite the
relevance and prognostic value of quadriceps muscle function, these
measurements have not been implemented as part of the routine evaluation of
patients with COPD. If the recently published, 2014 American Thoracic Society
and European Respiratory Society statement on Limb Muscle Dysfunction in COPD,
recommends using isometric assessments of quadriceps to assess muscle strength,
the most feasible, relevant and reliable way of measuring quadriceps muscle
endurance remains to be determined. Furthermore, no study has investigated the
association between quadriceps muscle endurance and objectively measured daily
physical activity. Further research is also warranted on the use of functional
assessment of quadriceps muscle function and its potential relationship to
daily life activities.
Study objective
The primary objective is to investigate the measurement properties of
isometric, isotonic and isokinetic protocol to assess quadriceps muscle
endurance in patients with COPD. Our secondary objective is to determine the
relationship between quadriceps strength, endurance and functional performance.
Study design
In this prospective study 20 patients with COPD will be recruited.
Demographics, standard spirometry, isometric quadriceps muscle strength and
assessment of functional performance (short performance physical battery test)
will be collected during an initial visit. Isometric, isokinetic and isotonic
assessment of quadriceps muscle endurance measured using a computerized
dynamometer will be obtained on two subsequent testing sessions separated at
least two days. The test-retest reliability, the minimal detectable change,
feasibility of administration of these tests and relationship to muscle
strength and functional performance of patients with COPD will be determined.
Study burden and risks
The risks on any undesirable side effects of this study are very low. If any,
the muscle function tests could be accompanied by some muscle soreness. This
feeling will naturally disappear within two days. At the same time, the
benefits of the study are high, because results from this study will show which
protocol for measuring muscle endurance is most appropriate to use in daily
clinical practice.
Geert Grooteplein-Zuid 10
GA 6525
NL
Geert Grooteplein-Zuid 10
GA 6525
NL
Listed location countries
Age
Inclusion criteria
1) at least 40 years old, 2) Diagnosis of moderate to very-severe COPD based on spirometry according the GOLD classification, 3) able to provide written informed consent, 4) able to follow verbal directions for testing.
Exclusion criteria
1) diagnosed with cardiovascular, neurological or neuromuscular conditions that could affect ability to perform the tests (e.g. stroke, knee osteoarthritis); 2) currently participating in a pulmonary rehabilitation program or been involved in pulmonary rehabilitation in the past 6 months; 3) experienced a COPD exacerbation in the past 3 months, 4) receiving a daily dose > 10mg of oral Prednisone within the past 3 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 | NL59926.091.16 |