The Relationships Between Neural Correlates of Effort Perception and Physical Activity Engagement

NCT06691490 | Recruiting

• 1 other identifier: 38RC23.0416
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives and research hypothesis Physical inactivity is a major health concern that has been linked to a variety of chronic diseases, including obesity, diabetes, cancer, cardiovascular diseases, and mental disorders. Recent studies have shown that regular physical activity can decrease the risk of SARS-CoV-2 infection, and severe COVID-19 illnesses, as well as improve antibody response to vaccine. As such, the adoption of a physically active lifestyle carries potential health benefits and has even been referred to as a "miracle cure" by the Academy of Royal Medical Colleges. Despite the implementation of policies that aimed to encourage regular physical activity, the prevalence of insufficient physical activity in high-income countries has increased since 2001 (32% in 2001 vs. 37% in 2018). Given the limited impact of health policies on physical activity engagement, it is essential to explore other avenues of research that can contribute to understanding this high level of inactivity and driving innovative strategies for encouraging physical activity. In this context, the automatic attraction of individuals toward activities associated with low-effort exertion is thought to play a key role in physical inactivity. Physical activity involves exerting physical effort, i.e., intensifying physical energy to achieve certain goals, such as increasing the force to lift a heavy object. This physical intensification is associated with the phenomenological experience of energy exertion. Higher effort perception is thought to be aversively valued by inactive individuals, inhibiting their engagement in regular physical activity. However, there is a lack of knowledge regarding the neural correlates of effort perception and how they relate to physical inactivity. It is crucial to gain insights into these neural correlates, especially to enhance our comprehension of the significance of effort minimization in physical inactivity. This project aims to decrease effort perception and improve the valuation of effort, incentivize regular physical activity, and improve overall health outcomes. Objective 1. Despite ongoing research, there is a lack of agreement on the neural mechanisms underlying effort perception as well as the role of sensorial feedback. Tasks EEG and fMRI aim to address this issue with original experimental methods in order to identify this neural mechanism. Hypothesis 1. Following A) muscle vibration and B) Induced ischemic paralysis and anesthesia, we expect decreased effort perception associated with a lower cortical S1 activation, unchanged activation in premotor structures, and preserved functional connectivity between premotor regions and S1. Objective 2. To unravel the neural interaction between efference copy and reafferent muscle spindle signals that contribute to effort perception Hypothesis 2. The neural correlates of effort perception involve interactions between premotor and sensory brain structures. Neural activation patterns of the brain regions implicated in effort perception vary depending on an individual's inclination to engage in physical activity. Objective 3. Task 3 will examine the potential of non-invasive brain stimulation techniques (TMS) to reduce effort perception in turn increase its perceived value quantified with the CR100 scale, the outcome variable of this study. Hypothesis 3. Vibration-induced desensitization of muscle spindles and the SMA cTBS reduce effort perception and improve the subjective value of physical effort.

Conditions

fMRI Research; Transcranial Magnetic Stimilation; EEG Brain Oscillations; Motor Task; Ischemic Nerve Block (INB); Muscle Vibration Protocol

Keywords

Perception of effort

Outcome Measures

Primary Outcomes (1)

• Effort perception

  Physical effort scale Category (C)-Ratio (R) (CR) scaling 100 or Borg centiMax® Scale (CR100) is a measure from 0 to 100 to rate the intensity of effort perception, where 0 means "nothing at all" (i.e. "no perception of effort at all") and 100 means "Maximal", that is, the maximal perception of effort experienced.

  From enrollment up to 12 months after

Secondary Outcomes (2)

• Resting-state and task fMRI functional connectivity

  From enrollment to 15 weeks after 60 healthy subjects will be assessed (4 subjects per week)

• EEG event related synchronization

  From enrollment to 40 weeks after

Study Arms (2)

Transcranial Magnetic Stimulation Sham

EXPERIMENTAL

Participants will engage in 4 cycling exercise visits and 4 effort-discounting task visits. Each of these 8 visits will be associated with one of the 4 stimulation conditions: vibration condition, sham vibration condition, cTBS over SMA. These 8 visits will be randomized across participant

Device: Transcranial Magnetic Stimulation Sham

TMS

PLACEBO COMPARATOR

cTBS over precuneus (control site).

Device: Transcranial Magnetic Stimulation Sham

Interventions

Transcranial Magnetic Stimulation Sham DEVICE

cTBS over SMA and cTBS over precuneus (control site)

TMS; Transcranial Magnetic Stimulation Sham

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal subjects all ranges age

You may not qualify if:

• Neurologic conditions that may bias the EEG or fMRI results such as epilepsy, tumors; stroke; which can be a casual MRI finding during the study.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• IRMage: collaborator

Study Sites (1)

Plateforme IRMaGe

La Tronche, 38700, France

RECRUITING

Related Publications (6)

• Pageaux B. Perception of effort in Exercise Science: Definition, measurement and perspectives. Eur J Sport Sci. 2016 Nov;16(8):885-94. doi: 10.1080/17461391.2016.1188992. Epub 2016 May 30.

  PMID: 27240002 BACKGROUND

• Inzlicht M, Shenhav A, Olivola CY. The Effort Paradox: Effort Is Both Costly and Valued. Trends Cogn Sci. 2018 Apr;22(4):337-349. doi: 10.1016/j.tics.2018.01.007. Epub 2018 Feb 21.

  PMID: 29477776 BACKGROUND

• Hallam J, Jones T, Alley J, Kohut ML. Exercise after influenza or COVID-19 vaccination increases serum antibody without an increase in side effects. Brain Behav Immun. 2022 May;102:1-10. doi: 10.1016/j.bbi.2022.02.005. Epub 2022 Feb 5.

  PMID: 35131444 BACKGROUND

• Christensen MS, Lundbye-Jensen J, Geertsen SS, Petersen TH, Paulson OB, Nielsen JB. Premotor cortex modulates somatosensory cortex during voluntary movements without proprioceptive feedback. Nat Neurosci. 2007 Apr;10(4):417-9. doi: 10.1038/nn1873. Epub 2007 Mar 18.

  PMID: 17369825 BACKGROUND

• Cheval B, Sieber S, Maltagliati S, Millet GP, Formanek T, Chalabaev A, Cullati S, Boisgontier MP. Muscle strength is associated with COVID-19 hospitalization in adults 50 years of age or older. J Cachexia Sarcopenia Muscle. 2021 Oct;12(5):1136-1143. doi: 10.1002/jcsm.12738. Epub 2021 Aug 6.

  PMID: 34363345 BACKGROUND

• Cheval B, Boisgontier MP. The Theory of Effort Minimization in Physical Activity. Exerc Sport Sci Rev. 2021 Jul 1;49(3):168-178. doi: 10.1249/JES.0000000000000252.

  PMID: 34112744 BACKGROUND

Study Officials

• Florian MONJO

  Université de Chambéry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian MONJO

CONTACT

0479758123; florian.monjo@univ-smb.fr

Diego LOMBARDO

CONTACT

0479758123; diego-martin.lombardo-vera@univ-smb.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Effort Perception; fMRI; EEG; Networks; Propioception

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 15, 2024
• Study Start: February 13, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: During the study
• Access Criteria: Researchers and technicians involved in the project will have access to the data by a sharing lin

Locations

FR (1)