An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-03.
Sponsored by Radboud University Medical Center · Observational
The primary objective is to assess the relation between involuntary and voluntary assessed quadriceps muscle endurance in patients with COPD. We hypothesized a good correlation (>0.8) between the measurements.
Rationale: Quadriceps muscle endurance is reduced in patients with COPD. However, no consensus has been reached yet on the best method to evaluate quadriceps muscle endurance. One important aspect is the large variety in protocols and devices used around the world. Commonly used and reliable measures are voluntary protocols performed on a computerized dynamometer. However, these voluntary measurements might also be influenced by external factors as patients effort or motivation. Therefore, it is important to evaluate the relation between voluntary and involuntary (i.e. electrical stimulated) assessed quadriceps muscle endurance.
Objective(s): The primary objective is to assess the relation between involuntary and voluntary assessed quadriceps muscle endurance in patients with COPD.
Study design: Cross-sectional observation study.
Study population: 20 COPD patients who perform baseline assessment at the pulmonary rehabilitation centre at Radboudumc (Nijmegen, the Netherlands).
Intervention: not applicable
Main study parameters/endpoints: The primary outcome will be the electrically evoked isometric quadriceps muscle endurance (fatigue resistance) and voluntary isokinetic (work fatigue index5) and isometric quadriceps endurance (time).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: BURDEN: All measurements are part of standard care, except for one questionnaire and (involuntary) electrical assessed quadriceps function. Thus, the additional burden for the patient is one additional measurement of approximately 70 minutes. RISKS: Performance of electrically evoked assessment of muscle function is not associated with a health risk. This procedure is non-invasive and not painful and performed routinely at the department of Physiology (Radboudumc, Nijmegen). Therefore, no safety risk is involved.
BENEFIT: The benefits will be high as it will provide more insight in the relation between voluntary and involuntary assessed quadriceps muscle endurance. This insight is necessary to optimize the clinical assessment of muscle endurance in patients with COPD.
GROUP RELATEDNESS: This will be the first study in which the relation between voluntary and involuntary assessed quadriceps muscle endurance in COPD will be investigated. These results will also be valuable for other diseases/conditions in which isolated muscle endurance should be assessed like asthma, pulmonary hypertension, etc.
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Patients with COPD that start with the pulmonary rehabilitation program at the Radboudumc in Nijmegen.
Exclusion Criteria:
Electrically evoked fatigue resistance (%)
Fatigue resistance (%) is the decline in muscle force generated using electrical stimulation.
Time frame: Performed in first week of pulmonary rehabilitation program
Voluntary isometric quadriceps endurance (time to fatigue).
Voluntary isometric quadriceps endurance (time to fatigue in seconds) is determined on the computerized dynamometer. The isometric endurance test protocol is performed by asking participants to maintain, for as long as possible, an isometric quadriceps contraction representing 60% of the individual isometric maximal voluntary contraction (MVC) force. The test will be ended if the force of the contraction was less than 50% of the MVC for three consecutive seconds.
Time frame: Performed in first week of pulmonary rehabilitation program
Voluntary isokinetic work fatigue index.
Voluntary isokinetic work fatigue (%) is the decline in work over 30 repetitions determined on the computerized dynamometer. The isokinetic protocol consists of 30 contractions at an angular velocity of 90°/s with maximal effort during extension and passive (submaximal) flexion. Work fatigue index = \*work first 5 repetitions - work last 5 repetitions) / work first 5 repetitions \* 100%
Time frame: Performed in first week of pulmonary rehabilitation program
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center