Study Stopped
recruitment difficulties
Neuromuscular Plasticity in Response to Obesity: Effects of Mechanical Overload, Metabolic Disorders and Age
PLANEUROB
2 other identifiers
interventional
92
1 country
1
Brief 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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Dec 2019
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedStudy Start
First participant enrolled
December 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2023
CompletedOctober 18, 2023
October 1, 2023
3.6 years
September 25, 2019
October 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximal torqueof the knee extensors (in N.m)
Maximal torque of the knee extensors (in N.m) measured with a dynamometer.
day 7
Fatiguability of the knee extensors (in N.m)
Fatiguability of the knee extensors (in N.m) measured with a dynamometer.
day 7
Secondary Outcomes (21)
Maximal muscle power of the lower limb
day 1
Functional capacity
day 1
Muscle contractile properties
day 7
Measure of alteration of the excitation contraction coupling
day 7
Measure of Sarcolemma excitability
day 7
- +16 more secondary outcomes
Study Arms (6)
YOMH
EXPERIMENTALYoung obese metabolically healthy Description: Aged from 20 to 40 years old and with a glycemia \< 1g/l and a triglyceridemia \< 1,5g/l.
YOMD
EXPERIMENTALYoung 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
EXPERIMENTALMiddle-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
EXPERIMENTALMiddle-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
EXPERIMENTALElderly obese metabolically healthy Description: Aged from 50 to 70 years old and with a glycemia \< 1g/l and a triglyceridemia \< 1,5g/l.
EOMD
EXPERIMENTALElderly obese with metabolic disorders Description: Aged from 50 to 70 years old and with a glycemia \> 1g/l and a triglyceridemia \> 1,5g/l.
Interventions
fatiguability of the knee extensors (in N.m) measured with a dynamometer.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Clermont Ferrand
Clermont-Ferrand, 63003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yves Boirie
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2019
First Posted
September 27, 2019
Study Start
December 2, 2019
Primary Completion
June 26, 2023
Study Completion
June 26, 2023
Last Updated
October 18, 2023
Record last verified: 2023-10