Pulmonary Disease, Chronic ObstructiveBionicNCT05427773
(In)Voluntary Assessed Quadriceps Muscle Endurance in COPD
An observational study of Pulmonary Disease, Chronic Obstructive, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jul 2022to 20 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD that start with the pulmonary rehabilitation program at the Radboudumc in Nijmegen.
Who may be able to join
- COPD, based on GOLD classification
- Clinically stable according to the pulmonary physician, i.e. no exacerbation and/or hospitalization within the previous 4 weeks
- Age between 40-80 years
- Take part in the pulmonary rehabilitation program at Radboudumc (Nijmegen)
Who cannot join
- Inability to understand the Dutch language
- Musculoskeletal and neurological problems influencing quadriceps muscle function testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: (In)Voluntary Assessed Quadriceps Muscle Endurance in Patients With Chronic Obstructive Pulmonary Disease: a Cross-sectional Observation Study.
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.
Read the detailed description
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Peripheral muscle endurance, Electrical stimulation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrically evoked fatigue resistance (%)
Fatigue resistance (%) is the decline in muscle force generated using electrical stimulation.
Measured: 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.
Measured: 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%
Measured: Performed in first week of pulmonary rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start5 Jul 2022
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427773
- Sponsor's protocol ID
- 1132321
- Acronym
- Bionic
- Status last verified
- May 2022
- First submitted
- 13 Jun 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (In)Voluntary Assessed Quadriceps Muscle Endurance in Patients With Chronic Obstructive Pulmonary Disease: a Cross-sectional Observation Study.
- ClinicalTrials.gov ID
- NCT05427773
- Acronym / sponsor ID
- Bionic / 1132321
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Peripheral muscle endurance, Electrical stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD that start with the pulmonary rehabilitation program at the Radboudumc in Nijmegen.
Key inclusion criteria (4 listed)
- COPD, based on GOLD classification
- Clinically stable according to the pulmonary physician, i.e. no exacerbation and/or hospitalization within the previous 4 weeks
- Age between 40-80 years
- Take part in the pulmonary rehabilitation program at Radboudumc (Nijmegen)
Key exclusion criteria (2 listed)
- Inability to understand the Dutch language
- Musculoskeletal and neurological problems influencing quadriceps muscle function testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Electrically evoked fatigue resistance (%)
Time frame: Performed in first week of pulmonary rehabilitation program
Fatigue resistance (%) is the decline in muscle force generated using electrical stimulation.
Voluntary isometric quadriceps endurance (time to fatigue).
Time frame: Performed in first week of pulmonary rehabilitation program
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.
Voluntary isokinetic work fatigue index.
Time frame: Performed in first week of pulmonary rehabilitation program
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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrically evoked fatigue resistance (%) (time frame: Performed in first week of pulmonary rehabilitation program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.