ObesityPLANEUROBNCT04106570
Neuromuscular Plasticity in Response to Obesity: Effects of Mechanical Overload, Metabolic Disorders and Age
A study testing fatiguability of the knee extensors in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Obese people suffer from significant functional limitations, which affect their quality of life and limit their physical activity level. Functional abilities are largely determined by neuromuscular properties, i.e the ability to produce a torque or a power, and fatigability, i.e the ability to maintain a high level of… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- fatiguability of the knee extensors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2019to 26 Jun 2023
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male subject, aged between 20 and 70 years old (inclusive terminals).
- Subject with a BMI greater than 30kg/m².
- Subject with a stable weight for at least 3 months before the start of the study.
- Subject capable and willing to comply with the protocol and willing to give informed consent in writing.
- Subject affiliated to a social security system.
Who cannot join
- Subject with a medical or surgical history deemed by the investigator to be incompatible with the study.
- Subject with a medical contraindication to intense activity.
- Subject weighing more than 170kg, which may damage the dynamometer chair.
- Subject with a treatment that, in the investigator's opinion, may interfere with the evaluation of study criteria, period of exclusion from a previous clinical study.
- Subject who has received a total amount of compensation since the beginning of the calendar year, greater than 4500 euros (amount may change depending on the regulation).
- Subject with a linguistic or physiological disability to sign informed consent.
- Subject deprived of liberty by administrative of juridical decision, under guardianship or curatorship.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Obese people suffer from significant functional limitations, which affect their quality of life and limit their physical activity level. Functional abilities are largely determined by neuromuscular properties, i.e the ability to produce a torque or a power, and fatigability, i.e the ability to maintain a high level of torque production during repeated contractions. Our previous studies on "healthy" obese adolescents (i.e without inflammation or metabolic disorder) suggests that obesity has positive effects on the neural and muscular factors responsible for torque production, with chronic overload acting as a strength training . However, this high torque level is associated with higher fatigability. These results are in contrast with the data obtained on adult obese patients (young and elderly), in whom torque production and fatigability appear to be more impaired, probably due to the development of metabolic disorders associated with obesity (inflammation, insulin resistance and lipid infiltration in muscle) and aging. The respective effects of mechanical overload, metabolic disorders (insulin resistance and lipid infiltration) and aging on neural and muscular factors of torque production and neuromuscular fatigue etiology are not currently known in young adult obese of elderly. Their relationship to the clinical symptoms of mobility troubles is also unknown. However, this knowledge is crucial for designing physical activity programs tailored and adapted to the level of metabolic impairment and age of obese patients. The hypothesis is that mechanical overload associated with obesity has positive effects on torque production in the absence of metabolic alteration and the effect of aging but negative effects on fatigability, mainly due to muscular factors; the insulin resistance increases peripheral fatigue (due to an alteration in the excitability of the sarcolemma during fatiguing exercise), central fatigue, and slows recovery; the development of inflammation and lipid infiltration, which are more pronounced in obese subjects, further affect torque production through inhibition of the nervous control and alteration of contractile properties and muscle architecture, all these phenomena leading to a decrease in torque production and increased fatigability, cumulating with the effects of the ageing (sarcopenia).
Read the detailed description
The limited data available in the literature suggest that insulin resistance, low-grade inflammation and muscle lipid infiltration may negatively impact torque production capacity and promote neuromuscular fatigability. Insulin resistance thus has effects on blood perfusion of active muscles, via effects on the autonomic nervous system (Petrofsky and al. 2009). Insulin resistance is also associated with a disruption of Na+/K+ pump activity, excitation-contraction coupling, intracellular ATP concentration (Orlando and al. 2016) and mitochondrial function (Slattery and al. 2014). All these effects are expected to increase the development of peripheral fatigue in obese patients with type 2 diabetes and impaired mitochondrial function is expected to result in impaired post-exercise recovery capacity. Inflammation can also affect the torque production. Some studies have shown a negative correlation between muscle torque production and inflammatory status in obese adolescents (Ruiz and al. 2008) and seniors (Visser and al. 2002). Inflammation is associated with reduced muscle mass, which may result from inhibition of protein synthesis (Guillet and al. 2012). Inflammation could also have negative effects on the nervous factors of torque production, via the stimulation of afferences III and IV, as suggested in the healthy subject (Dousset and al. 2007). However, this has never been demonstrated. Finally, oedema associated with the inflammatory reaction could modify the architecture and muscle dimensions, as demonstrated in healthy subjects (Ishikawa and al. 2006) or those suffering from inflammatory diseases (Kaya and al. 2013). To date, the consequences of low-grade inflammation, combined or not with aging, on the muscle and nervous factors of force production in obese adults have yet to be characterized experimentally. Muscle lipid infiltration can also have negative effects on muscle protein synthesis (Tardif and al. 2014) and especially on strength. This has been frequently reported in non-obese elderly people (Sipilä and Suominen 1994). Interestingly, another study reported a negative correlation between intramuscular lipid content and level of quadriceps voluntary activation in non-obese elderly people (Yoshida and al. 2012), which may explain the correlation discussed above. To our knowledge, no data are available for adult obese patients. However, it can be assumed that lipid infiltration would have inhibitory effects on the level of activation of motor units, and therefore on the production of force. It is also likely that lipid infiltration limits muscle architectural adaptations to overweight (contractile and adipose tissues competing to develop in a restricted muscle volume). Mathematical modelling of the effects of lipid infiltration on muscle mechanics (Rahemi and al. 2015) suggests that intramuscular lipids could disrupt contractile activity by limiting the shortening of muscle fascicles, and transverse muscle deformation during muscle contraction. However, these theoretical predictions have yet to be confirmed by experimental data.
The PLANEUROB research project is a physiological observational study comparing the respective effects of mechanical overload, metabolic disorders and age on torque production, fatigability and functional capacity in obese people. Subjects will have to perform a fatigue protocol, an adapted Margaria test and a 6 minutes walking test in one session. Blood samples, muscular ultrasound scanner and physical activity assessment will also be achieved.
Data will be analysed using LabChart 7.3 Pro software (ADInstrument, New South Wales, Australia), ImageJ (NIH Image, Bethesda, Maryland, USA) and Statistica 8.0 software (StatSoft, Inc.) and significance will be accepted at a two-sided alpha level of p<.05. The normality and homogeneity of the variables will be checked respectively from a Shapiro- Wilk test and a Barlett test. If normality and homogeneity of the variables are verified, absolute values of variables (Torque, EMG, mean grey, etc.) will be compared using two factors (age x metabolic disorders) analyses of variance (ANOVA) with repeated measures. If analyses reveal a significant effect of any factor or interaction of factors, post-hoc Newman-Keuls tests will be performed to determine differences between the different conditions.
- Conditions
- Obesity
- Being tested
- fatiguability of the knee extensors
- Keywords
- Obese, Torque production, Neuromuscular fatigue, Electrical muscle stimulation, Knee extensors, Metabolic disorders
- Medical subject headings
- Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fatiguability of the knee extensorsOther
fatiguability of the knee extensors (in N.m) measured with a dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| YOMH | Experimental | Young obese metabolically healthy Description: Aged from 20 to 40 years old and with a glycemia < 1g/l and a triglyceridemia < 1,5g/l. Receives: Other: fatiguability of the knee extensors |
| YOMD | Experimental | Young obese with metabolic disorders
Description: Aged from 20 to 40 years old and with a glycemia > 1g/l and a triglyceridemia > 1,5g/l. Receives: Other: fatiguability of the knee extensors |
| MAOMH | Experimental | Middle-Age obese metabolically healthy
Description: Aged from 40 to 50 years old and with a glycemia < 1g/l and a triglyceridemia < 1,5g/l. Receives: Other: fatiguability of the knee extensors |
| MAOMD | Experimental | Middle-Age obese with metabolic disorders Description: Aged from 40 to 50 years old and with a glycemia > 1g/l and a triglyceridemia > 1,5g/l. Receives: Other: fatiguability of the knee extensors |
| EOMH | Experimental | Elderly obese metabolically healthy
Description: Aged from 50 to 70 years old and with a glycemia < 1g/l and a triglyceridemia < 1,5g/l. Receives: Other: fatiguability of the knee extensors |
| EOMD | Experimental | Elderly obese with metabolic disorders
Description: Aged from 50 to 70 years old and with a glycemia > 1g/l and a triglyceridemia > 1,5g/l. Receives: Other: fatiguability of the knee extensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal torqueof the knee extensors (in N.m)
Maximal torque of the knee extensors (in N.m) measured with a dynamometer.
Measured: day 7
Fatiguability of the knee extensors (in N.m)
Fatiguability of the knee extensors (in N.m) measured with a dynamometer.
Measured: day 7
Secondary outcomes (21)
Maximal muscle power of the lower limb
Maximal muscle power of the lower limb muscles measured during an adapted Margaria test (15 steps by walking).
Measured: day 1
Functional capacity
Functional capacity assessed by a 6 minutes walking test.
Measured: day 1
Muscle contractile properties
Muscle contractile properties using muscle twitches and the doublet torque amplitude (100Hz, in N.m) measured using electrical muscle stimulation.
Measured: day 7
Measure of alteration of the excitation contraction coupling
Alteration of the excitation contraction coupling using the high frequency (100Hz)/ low frequency (10Hz) ratio evoked by electrical muscle stimulation.
Measured: day 7
Measure of Sarcolemma excitability
Sarcolemma excitability using muscle action potential amplitude (i.e M-wave, in mV) evoked by electrical muscle stimulation and measured by surface electromyography (EMG).
Measured: day 7
Measure of Voluntary activation level (%)
Voluntary activation level (%) assessed by using the twitch interpolation technique.
Measured: day 7
Measure of Fascicule length (mm),
Fascicule length (mm) measured by B-mode real time ultrasound scanner.
Measured: day 1
Measure of pennation angle (degree)
pennation angle (degree) measured by B-mode real time ultrasound scanner.
Measured: day 1
Measure cross-sectional area (cm²)
cross-sectional area (cm²) measured by B-mode real time ultrasound scanner.
Measured: day 1
Measure muscular lipid infiltration (%)
muscular lipid infiltration (%) measured by B-mode real time ultrasound scanner.
Measured: day 1
Measure of Glycemia (g/L)
Glycemia in blood samples.
Measured: day 1
Measure of insulinemia (pmol/L)
insulinemia in blood samples.
Measured: day 1
Measure of HbA1c(mmol/mol)
HbA1c in blood samples.
Measured: day 1
Measure of triglyceridemia (g/L)
triglyceridemia in blood samples.
Measured: day 1
Measure of CRP (mg/L)
CRP in blood samples.
Measured: day 1
Height in cm
Anthropometric measure of height
Measured: day 1
weight in kg
Anthropometric measure of weight
Measured: day 1
waist circumference in cm
Anthropometric measure of waist circumference.
Measured: day 1
Physical activity
Physical activity measured with Global Physical Activity Questionnaire
Measured: day 1
Physical activity
Physical activity measured with Physical Activity Questionnaire
Measured: day 1
Physical activity
Physical activity measured accelerometery.
Measured: day2, day 3, day 4, day 5, day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start2 Dec 2019
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Responsible party
- Sponsor
- Investigators
- Yves Boirie, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106570
- Sponsor's protocol ID
- RBHP 2019 BOIRIE 3 (Planeurob)
- Other IDs
- 2019-A00788-49
- Acronym
- PLANEUROB
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2019
- Last updated
- 18 Oct 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 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Plasticity in Response to Obesity: Effects of Mechanical Overload, Metabolic Disorders and Age
- ClinicalTrials.gov ID
- NCT04106570
- Acronym / sponsor ID
- PLANEUROB / RBHP 2019 BOIRIE 3 (Planeurob)
- Conditions
- Obesity
- Keywords
- Obese, Torque production, Neuromuscular fatigue, Electrical muscle stimulation, Knee extensors, Metabolic disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 27 Sep 2019 (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.
Obese people suffer from significant functional limitations, which affect their quality of life and limit their physical activity level. Functional abilities are largely determined by neuromuscular properties, i.e the ability to produce a torque or a power, and fatigability, i.e the ability to maintain a high level of torque production during repeated contractions. Our previous studies on "healthy" obese adolescents (i.e without inflammation or metabolic disorder) suggests that obesity has positive effects on the neural and muscular factors responsible for torque production, with chronic overload acting as a strength training . However, this high torque level is associated with higher fatigability. These results are in contrast with the data obtained on adult obese patients (young and elderly), in whom torque production and fatigability appear to be more impaired, probably due to the development of metabolic disorders associated with obesity (inflammation, insulin resistance and lipid infiltration in muscle) and aging. The respective effects of mechanical overload, metabolic disorders (insulin resistance and lipid infiltration) and aging on neural and muscular factors of torque production and neuromuscular fatigue etiology are not currently known in young adult obese of elderly. Their relationship to the clinical symptoms of mobility troubles is also unknown. However, this knowledge is crucial for designing physical activity programs tailored and adapted to the level of metabolic impairment and age of obese patients. The hypothesis is that mechanical overload associated with obesity has positive effects on torque production in the absence of metabolic alteration and the effect of aging but negative effects on fatigability, mainly due to muscular factors; the insulin resistance increases peripheral fatigue (due to an alteration in the excitability of the sarcolemma during fatiguing exercise), central fatigue, and slows recovery; the development of inflammation and lipid infiltration, which are more pronounced in obese subjects, further affect torque production through inhibition of the nervous control and alteration of contractile properties and muscle architecture, all these phenomena leading to a decrease in torque production and increased fatigability, cumulating with the effects of the ageing (sarcopenia).
Detailed description
The limited data available in the literature suggest that insulin resistance, low-grade inflammation and muscle lipid infiltration may negatively impact torque production capacity and promote neuromuscular fatigability. Insulin resistance thus has effects on blood perfusion of active muscles, via effects on the autonomic nervous system (Petrofsky and al. 2009). Insulin resistance is also associated with a disruption of Na+/K+ pump activity, excitation-contraction coupling, intracellular ATP concentration (Orlando and al. 2016) and mitochondrial function (Slattery and al. 2014). All these effects are expected to increase the development of peripheral fatigue in obese patients with type 2 diabetes and impaired mitochondrial function is expected to result in impaired post-exercise recovery capacity. Inflammation can also affect the torque production. Some studies have shown a negative correlation between muscle torque production and inflammatory status in obese adolescents (Ruiz and al. 2008) and seniors (Visser and al. 2002). Inflammation is associated with reduced muscle mass, which may result from inhibition of protein synthesis (Guillet and al. 2012). Inflammation could also have negative effects on the nervous factors of torque production, via the stimulation of afferences III and IV, as suggested in the healthy subject (Dousset and al. 2007). However, this has never been demonstrated. Finally, oedema associated with the inflammatory reaction could modify the architecture and muscle dimensions, as demonstrated in healthy subjects (Ishikawa and al. 2006) or those suffering from inflammatory diseases (Kaya and al. 2013). To date, the consequences of low-grade inflammation, combined or not with aging, on the muscle and nervous factors of force production in obese adults have yet to be characterized experimentally. Muscle lipid infiltration can also have negative effects on muscle protein synthesis (Tardif and al. 2014) and especially on strength. This has been frequently reported in non-obese elderly people (Sipilä and Suominen 1994). Interestingly, another study reported a negative correlation between intramuscular lipid content and level of quadriceps voluntary activation in non-obese elderly people (Yoshida and al. 2012), which may explain the correlation discussed above. To our knowledge, no data are available for adult obese patients. However, it can be assumed that lipid infiltration would have inhibitory effects on the level of activation of motor units, and therefore on the production of force. It is also likely that lipid infiltration limits muscle architectural adaptations to overweight (contractile and adipose tissues competing to develop in a restricted muscle volume). Mathematical modelling of the effects of lipid infiltration on muscle mechanics (Rahemi and al. 2015) suggests that intramuscular lipids could disrupt contractile activity by limiting the shortening of muscle fascicles, and transverse muscle deformation during muscle contraction. However, these theoretical predictions have yet to be confirmed by experimental data.
The PLANEUROB research project is a physiological observational study comparing the respective effects of mechanical overload, metabolic disorders and age on torque production, fatigability and functional capacity in obese people. Subjects will have to perform a fatigue protocol, an adapted Margaria test and a 6 minutes walking test in one session. Blood samples, muscular ultrasound scanner and physical activity assessment will also be achieved.
Data will be analysed using LabChart 7.3 Pro software (ADInstrument, New South Wales, Australia), ImageJ (NIH Image, Bethesda, Maryland, USA) and Statistica 8.0 software (StatSoft, Inc.) and significance will be accepted at a two-sided alpha level of p<.05. The normality and homogeneity of the variables will be checked respectively from a Shapiro- Wilk test and a Barlett test. If normality and homogeneity of the variables are verified, absolute values of variables (Torque, EMG, mean grey, etc.) will be compared using two factors (age x metabolic disorders) analyses of variance (ANOVA) with repeated measures. If analyses reveal a significant effect of any factor or interaction of factors, post-hoc Newman-Keuls tests will be performed to determine differences between the different conditions.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| YOMH | Experimental | Other: fatiguability of the knee extensorsYoung obese metabolically healthy Description: Aged from 20 to 40 years old and with a glycemia < 1g/l and a triglyceridemia < 1,5g/l. |
| YOMD | Experimental | Other: fatiguability of the knee extensorsYoung obese with metabolic disorders Description: Aged from 20 to 40 years old and with a glycemia > 1g/l and a triglyceridemia > 1,5g/l. |
| MAOMH | Experimental | Other: fatiguability of the knee extensorsMiddle-Age obese metabolically healthy Description: Aged from 40 to 50 years old and with a glycemia < 1g/l and a triglyceridemia < 1,5g/l. |
| MAOMD | Experimental | Other: fatiguability of the knee extensorsMiddle-Age obese with metabolic disorders Description: Aged from 40 to 50 years old and with a glycemia > 1g/l and a triglyceridemia > 1,5g/l. |
| EOMH | Experimental | Other: fatiguability of the knee extensorsElderly obese metabolically healthy Description: Aged from 50 to 70 years old and with a glycemia < 1g/l and a triglyceridemia < 1,5g/l. |
| EOMD | Experimental | Other: fatiguability of the knee extensorsElderly obese with metabolic disorders Description: Aged from 50 to 70 years old and with a glycemia > 1g/l and a triglyceridemia > 1,5g/l. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female or male subject, aged between 20 and 70 years old (inclusive terminals).
- Subject with a BMI greater than 30kg/m².
- Subject with a stable weight for at least 3 months before the start of the study.
- Subject capable and willing to comply with the protocol and willing to give informed consent in writing.
- Subject affiliated to a social security system.
Key exclusion criteria (8 listed)
- Subject with a medical or surgical history deemed by the investigator to be incompatible with the study.
- Subject with a medical contraindication to intense activity.
- Subject weighing more than 170kg, which may damage the dynamometer chair.
- Subject with a treatment that, in the investigator's opinion, may interfere with the evaluation of study criteria, period of exclusion from a previous clinical study.
- Subject who has received a total amount of compensation since the beginning of the calendar year, greater than 4500 euros (amount may change depending on the regulation).
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 |
|---|---|---|
| fatiguability of the knee extensorsfatiguability of the knee extensors (in N.m) measured with a dynamometer. | Other | EOMD, EOMH, MAOMD, MAOMH, YOMD, YOMH |
Primary outcome
Maximal torqueof the knee extensors (in N.m)
Time frame: day 7
Maximal torque of the knee extensors (in N.m) measured with a dynamometer.
Fatiguability of the knee extensors (in N.m)
Time frame: day 7
Fatiguability of the knee extensors (in N.m) measured with a dynamometer.
21 secondary outcomes
Maximal muscle power of the lower limb
Time frame: day 1
Functional capacity
Time frame: day 1
Muscle contractile properties
Time frame: day 7
Measure of alteration of the excitation contraction coupling
Time frame: day 7
Measure of Sarcolemma excitability
Time frame: day 7
Measure of Voluntary activation level (%)
Time frame: day 7
Measure of Fascicule length (mm),
Time frame: day 1
Measure of pennation angle (degree)
Time frame: day 1
Measure cross-sectional area (cm²)
Time frame: day 1
Measure muscular lipid infiltration (%)
Time frame: day 1
Measure of Glycemia (g/L)
Time frame: day 1
Measure of insulinemia (pmol/L)
Time frame: day 1
Measure of HbA1c(mmol/mol)
Time frame: day 1
Measure of triglyceridemia (g/L)
Time frame: day 1
Measure of CRP (mg/L)
Time frame: day 1
Height in cm
Time frame: day 1
weight in kg
Time frame: day 1
waist circumference in cm
Time frame: day 1
Physical activity
Time frame: day 1
Physical activity
Time frame: day 1
Physical activity
Time frame: day2, day 3, day 4, day 5, day 6
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 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.
Yves Boirie principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fatiguability of the knee extensors in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Oct 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 France. 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 was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
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?
Maximal torqueof the knee extensors (in N.m) (time frame: day 7). The study lists 2 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 18 Oct 2023.