Muscle; FatigueNCT01345461
Fatigability of the Quadriceps Muscle in Non-cooperating Subjects
An observational study of Muscle; Fatigue and Heart, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
As the critical care practice has improved over the last decades more patients are recovering from intensive care therapy. However, muscle atrophy and neuromuscular dysfunction are commonly observed sequelae after critical illness and are thought to play important roles in the development of intensive care unit… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Muscle; Fatigue, Heart
- What is being tested?
- transcutaneous electrical muscle stimulation, (model DS7A, Digitimer, Welwyn, Garden City, Hertfordshire, UK)
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Jun 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: healthy adult volunteers
Who may be able to join
- healthy adult volunteers
Who cannot join
- medical history of cardiovascular, metabolic or neuromuscular disorders.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of intensive care 4131, Rigshospitalet, Copenhagen University Hospital
Copenhagen, DK-2100 OE
About this study
As the critical care practice has improved over the last decades more patients are recovering from intensive care therapy. However, muscle atrophy and neuromuscular dysfunction are commonly observed sequelae after critical illness and are thought to play important roles in the development of intensive care unit acquired weakness (ICUAW). As a consequence, these entities may contribute to the impaired physical function and prolonged convalescence reported by ICU patients up to twelve months after discharge. Thus, strategies to counteract muscle atrophy and neuromuscular dysfunction acquired during the ICU stay may therefore potentially improve physical outcome and reduce the overall burden of critical illness. Limited information is available on muscle function in ICU patients and to our knowledge no muscle stimulation methods are currently available for evaluating muscle fatigue in large, proximal muscles groups, such as m. quadriceps, in non-cooperating ICU patients.
Read the detailed description
Positioning of the subject: A special device, consisting of a rigid padded wooden board resting on metal bar, which was attached to the metal framing of the hospital bed, held the knee joint at a 90-degree angle and secured firm support of the entire thigh (Fig. 1). The positioning was chosen to reduce unnecessary movement and minimize risk for mechanical ventilated ICU patients. Isometric knee extension forces were therefore measured while subjects were placed in a supine position in a hospital bed with a 30-degree incline of the head and torso.
Electrical muscle stimulation: Two carbon electrode pads were placed distally over the motor point of the medial (vastus medialis) and lateral (vastus lateralis) heads of the quadriceps muscle. The motor point was defined as the location that corresponded to the lowest possible threshold current and the motor threshold current was defined as the lowest train stimulation current that resulted in visible muscle contraction. Another pair of electrodes (5x9 cm) was placed 5 cm distal to the inguinal fold (10). To optimize electrical conduction, the skin was shaved and rinsed before applying the electrodes. This approach was similar to previous studies (11).
Initially, two constant current high voltage stimulators delivered ten single stimuli twitches with biphasic square pulses at widths of 300 μs. A train generator was then switched on, triggering the delivery a 35 Hz current in bouts of 3 seconds periods separated by 1-second pause for a total of 40 tetanic contractions. In immediate succession to the tetanic contractions a second series of ten single twitch stimuli ended the protocol. Figure 2 show an example of an actual recording of the force response curve.
On the first experimental day testing current was adjusted to 75% above the motor threshold current. On the second testing day, training intensity was determined as the stimulation intensity corresponding to the same force output level (mV) as generated by the first tetanic contraction on the first testing day, while maintaining the same ratio between the medial and the lateral intensity levels.
The stimulation parameters and the two-channel stimulation method were chosen in order to increase the amount of stimulated muscle mass, ensure a safe, tetanic contraction in the non-cooperating subjects; to reduce risk of excessive muscle damage and to avoid recruitment of sensory fibers and thus minimize discomfort.
Force measurements: A height adjustable strain gauge, placed beneath the bed, were secured to the metal framing of the bed and connected horizontally (180 degree) to the subjects with a non-extensible strap placed around the angle of the subject. To minimize leg movement a second non-extensible strap were attached between the ankle and a fixed metal bar, pulling directly opposite the strap holding the strain gauge. A bridge circuit was used to detect changes in relative resistance in the strain gauge and transformed voltage changes, proportional to the torque generated by the activated muscle, were then A/D converted, sampled at 1 kHz and subsequently stored on a personal computer for further offline analysis.
Off line data analysis All motor current threshold values were the average of two measurements per side.
Tetanic contractions: To ensure attainment of plateau level of contractions torque values were calculated as the mean of the last second of the 3-s contraction. Peak tetanic torque values were the highest obtained value. The tetanic stimulation period was subdivided into five intervals where interval 1 corresponds to the first 60 seconds (1-15 contractions), interval 2 from 61-120 seconds (16-30 contractions), interval 3 from 121-160 seconds (31-40 contractions), interval 4 the first 120 seconds (1-30 contractions) and interval 5 to the total period of 160 seconds (1-40 contractions). For each interval the resistance to muscle fatigue was expressed as a Fatigue Index (FI) and calculated as the ratio between the sum of peak torque values from the final three contractions relative to the sum of peak torque values from the first three contractions. Furthermore were peak torque values for each contraction plotted and the slope of the regression line for each interval calculated.
Twitch contractions: All data were 15Hz low pass filtered and peak torque and rise-time were calculated before and after the tetanic stimulation period. For each 10-twitch series peak torque and rise-time (the slope between 30% and 70% of the twitch peak force, Nm/s) was calculated for the individual twitches. Both peak torque and rise-time were then expressed as the average values of all twitches before and after the tetanic contraction.
Data integrity:
Care was taken to ensure identical study conditions and uniformity in regard to time of day, location, equipment and procedure. Furthermore, all tests were conducted in a temperature-controlled environment with a single observer assessment and measurements regime maintained throughout the study. The same investigator (JBP), who was blinded to the intensity level, determined all threshold values and MR conducted all on-line muscle force measurements. To ensure optimal comparison between the two experimental secessions subjects were placed in a standardized position securing uniformity of posture, joint positions and orientation of the thigh. To reduce day-to-day variations in electrode placement on the thigh, these were marked, along with at least three permanent landmarks, on a transparent paper, thus serving as a "map" for a precise identification. On day seven the same investigator (JBP) then carefully replaced the electrodes identical to day 1. On both testing days, gauges were calibrated and each subject received a short standardized low intensity familiarisation session prior to the testing procedure to ensure potentiation of muscle tissue during which electrical muscle stimulation and the present protocol were carefully explained. Left/right testing order was determined after randomisation with the same order of testing maintained on the second experimental day. Subjects were instructed to be as relaxed as possible and to suppress any voluntary contraction during the test. Finally, to ensure the quality of the recorded data, knee extension forces were immediately displayed on-line on a computer screen for visual inspection.
- Conditions
- Muscle; Fatigue, Heart
- Being tested
- transcutaneous electrical muscle stimulation, (model DS7A, Digitimer, Welwyn, Garden City, Hertfordshire, UK)
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical muscle stimulation, (model DS7A, Digitimer, Welwyn, Garden City, Hertfordshire, UK)Device
Also called Health young subjects
two constant current high voltage stimulators delivered ten single stimuli twitches with biphasic square pulses at widths of 300 μs. A train generator was then switched on, triggering the delivery a 35 Hz current in bouts of 3 seconds periods separated by 1-second pause for a total of 40 tetanic contractions. In immediate succession to the tetanic contractions a second series of ten single twitch stimuli ended the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adult volunteers | Twelve healthy adult volunteers (6 men, 6 women) Receives: Device: transcutaneous electrical muscle stimulation, (model DS7A, Digitimer, Welwyn, Garden City, Hertfordshire, UK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Index (ratio)
The tetanic stimulation period was subdivided into five intervals. For each interval the resistance to muscle fatigue was expressed as a Fatigue Index (FI) and calculated as the ratio between the sum of peak torque values from the final three contractions relative to the sum of peak torque values from the first three contractions.
Measured: One week
Secondary outcomes (1)
Slope of regression line (Nm/s)
Peak torque values for each contraction were plotted and the slope of the regression line for each interval calculated.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle; FatigueStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Jesper Poulsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jesper B Poulsen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345461
- Sponsor's protocol ID
- 25428
- Status last verified
- Sep 2017
- First submitted
- 15 Apr 2011
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poulsen JB, Rose MH, Moller K, Perner A, Jensen BR. A Novel Noninvasive Method for Measuring Fatigability of the Quadriceps Muscle in Noncooperating Healthy Subjects. Biomed Res Int. 2015;2015:193493. doi: 10.1155/2015/193493. Epub 2015 Jul 21.
PubMed 26266252
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigability of the Quadriceps Muscle in Non-cooperating Subjects
- ClinicalTrials.gov ID
- NCT01345461
- Acronym / sponsor ID
- 25428
- Conditions
- Muscle; Fatigue, Heart
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jan 2010 (actual)
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 May 2011 (estimated)
- 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.
As the critical care practice has improved over the last decades more patients are recovering from intensive care therapy. However, muscle atrophy and neuromuscular dysfunction are commonly observed sequelae after critical illness and are thought to play important roles in the development of intensive care unit acquired weakness (ICUAW). As a consequence, these entities may contribute to the impaired physical function and prolonged convalescence reported by ICU patients up to twelve months after discharge. Thus, strategies to counteract muscle atrophy and neuromuscular dysfunction acquired during the ICU stay may therefore potentially improve physical outcome and reduce the overall burden of critical illness. Limited information is available on muscle function in ICU patients and to our knowledge no muscle stimulation methods are currently available for evaluating muscle fatigue in large, proximal muscles groups, such as m. quadriceps, in non-cooperating ICU patients.
Detailed description
Positioning of the subject: A special device, consisting of a rigid padded wooden board resting on metal bar, which was attached to the metal framing of the hospital bed, held the knee joint at a 90-degree angle and secured firm support of the entire thigh (Fig. 1). The positioning was chosen to reduce unnecessary movement and minimize risk for mechanical ventilated ICU patients. Isometric knee extension forces were therefore measured while subjects were placed in a supine position in a hospital bed with a 30-degree incline of the head and torso.
Electrical muscle stimulation: Two carbon electrode pads were placed distally over the motor point of the medial (vastus medialis) and lateral (vastus lateralis) heads of the quadriceps muscle. The motor point was defined as the location that corresponded to the lowest possible threshold current and the motor threshold current was defined as the lowest train stimulation current that resulted in visible muscle contraction. Another pair of electrodes (5x9 cm) was placed 5 cm distal to the inguinal fold (10). To optimize electrical conduction, the skin was shaved and rinsed before applying the electrodes. This approach was similar to previous studies (11).
Initially, two constant current high voltage stimulators delivered ten single stimuli twitches with biphasic square pulses at widths of 300 μs. A train generator was then switched on, triggering the delivery a 35 Hz current in bouts of 3 seconds periods separated by 1-second pause for a total of 40 tetanic contractions. In immediate succession to the tetanic contractions a second series of ten single twitch stimuli ended the protocol. Figure 2 show an example of an actual recording of the force response curve.
On the first experimental day testing current was adjusted to 75% above the motor threshold current. On the second testing day, training intensity was determined as the stimulation intensity corresponding to the same force output level (mV) as generated by the first tetanic contraction on the first testing day, while maintaining the same ratio between the medial and the lateral intensity levels.
The stimulation parameters and the two-channel stimulation method were chosen in order to increase the amount of stimulated muscle mass, ensure a safe, tetanic contraction in the non-cooperating subjects; to reduce risk of excessive muscle damage and to avoid recruitment of sensory fibers and thus minimize discomfort.
Force measurements: A height adjustable strain gauge, placed beneath the bed, were secured to the metal framing of the bed and connected horizontally (180 degree) to the subjects with a non-extensible strap placed around the angle of the subject. To minimize leg movement a second non-extensible strap were attached between the ankle and a fixed metal bar, pulling directly opposite the strap holding the strain gauge. A bridge circuit was used to detect changes in relative resistance in the strain gauge and transformed voltage changes, proportional to the torque generated by the activated muscle, were then A/D converted, sampled at 1 kHz and subsequently stored on a personal computer for further offline analysis.
Off line data analysis All motor current threshold values were the average of two measurements per side.
Tetanic contractions: To ensure attainment of plateau level of contractions torque values were calculated as the mean of the last second of the 3-s contraction. Peak tetanic torque values were the highest obtained value. The tetanic stimulation period was subdivided into five intervals where interval 1 corresponds to the first 60 seconds (1-15 contractions), interval 2 from 61-120 seconds (16-30 contractions), interval 3 from 121-160 seconds (31-40 contractions), interval 4 the first 120 seconds (1-30 contractions) and interval 5 to the total period of 160 seconds (1-40 contractions). For each interval the resistance to muscle fatigue was expressed as a Fatigue Index (FI) and calculated as the ratio between the sum of peak torque values from the final three contractions relative to the sum of peak torque values from the first three contractions. Furthermore were peak torque values for each contraction plotted and the slope of the regression line for each interval calculated.
Twitch contractions: All data were 15Hz low pass filtered and peak torque and rise-time were calculated before and after the tetanic stimulation period. For each 10-twitch series peak torque and rise-time (the slope between 30% and 70% of the twitch peak force, Nm/s) was calculated for the individual twitches. Both peak torque and rise-time were then expressed as the average values of all twitches before and after the tetanic contraction.
Data integrity:
Care was taken to ensure identical study conditions and uniformity in regard to time of day, location, equipment and procedure. Furthermore, all tests were conducted in a temperature-controlled environment with a single observer assessment and measurements regime maintained throughout the study. The same investigator (JBP), who was blinded to the intensity level, determined all threshold values and MR conducted all on-line muscle force measurements. To ensure optimal comparison between the two experimental secessions subjects were placed in a standardized position securing uniformity of posture, joint positions and orientation of the thigh. To reduce day-to-day variations in electrode placement on the thigh, these were marked, along with at least three permanent landmarks, on a transparent paper, thus serving as a "map" for a precise identification. On day seven the same investigator (JBP) then carefully replaced the electrodes identical to day 1. On both testing days, gauges were calibrated and each subject received a short standardized low intensity familiarisation session prior to the testing procedure to ensure potentiation of muscle tissue during which electrical muscle stimulation and the present protocol were carefully explained. Left/right testing order was determined after randomisation with the same order of testing maintained on the second experimental day. Subjects were instructed to be as relaxed as possible and to suppress any voluntary contraction during the test. Finally, to ensure the quality of the recorded data, knee extension forces were immediately displayed on-line on a computer screen for visual inspection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adult volunteers | – | Device: transcutaneous electrical muscle stimulation, (model DS7A, Digitimer, Welwyn, Garden City, Hertfordshire, UK)Twelve healthy adult volunteers (6 men, 6 women) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- healthy adult volunteers
Key inclusion criteria (1 listed)
- healthy adult volunteers
Key exclusion criteria (1 listed)
- medical history of cardiovascular, metabolic or neuromuscular disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous electrical muscle stimulation, (model DS7A, Digitimer, Welwyn, Garden City, Hertfordshire, UK)Also: Health young subjectstwo constant current high voltage stimulators delivered ten single stimuli twitches with biphasic square pulses at widths of 300 μs. A train generator was then switched on, triggering the delivery a 35 Hz current in bouts of 3 seconds periods separated by 1-second pause for a total of 40 tetanic contractions. In immediate succession to the tetanic contractions a second series of ten single twitch stimuli ended the protocol. | Device | Healthy adult volunteers |
Primary outcome
Fatigue Index (ratio)
Time frame: One week
The tetanic stimulation period was subdivided into five intervals. For each interval the resistance to muscle fatigue was expressed as a Fatigue Index (FI) and calculated as the ratio between the sum of peak torque values from the final three contractions relative to the sum of peak torque values from the first three contractions.
1 secondary outcome
Slope of regression line (Nm/s)
Time frame: One week
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 29 Sep 2017.
- Derived from this study: PubMed 26266252Poulsen JB, Rose MH, Moller K, Perner A, Jensen BR. A Novel Noninvasive Method for Measuring Fatigability of the Quadriceps Muscle in Noncooperating Healthy Subjects. Biomed Res Int. 2015;2015:193493. doi: 10.1155/2015/193493. Epub 2015 Jul 21.
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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.
Jesper B Poulsen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Muscle; Fatigue and Heart, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 1 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 29 Sep 2017. 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 Denmark. 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?
Fatigue Index (ratio) (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01345461, which also lists 1 linked publication.
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 29 Sep 2017.