Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05910814
Other study ID # 69HCL22_0425
Secondary ID 2023-A00155-40
Status Recruiting
Phase N/A
First received
Last updated
Start date June 16, 2023
Est. completion date October 28, 2024

Study information

Verified date June 2023
Source Hospices Civils de Lyon
Contact Maxime PINGON, MD
Phone 04.72.07.18.62
Email maxime.pingon@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Motor learning is crucial for human daily routine, involving the acquisition of new movements. It consists of an online acquisition phase followed by offline consolidation, where motor memory is organized into stable representations. Acquisition can be achieved through physical practice (PP, overt repetition of movement) or mental rehearsal using motor imagery (MI). Recent studies suggest that high-intensity interval physical exercise (HIIE) enhances motor learning, particularly during consolidation, by promoting neural plasticity mediated by brain-derived neurotrophic factor (BDNF). However, the impact of HIIE on sequential motor consolidation with PP or MI remains poorly understood. In contrast, sleep deprivation (SD) reduces BDNF release and neural plasticity. Limited research has explored the effects of SD on motor acquisition, especially sequential motor learning. Considering the opposing effects of HIIE and SD, performing HIIE after SD may protect motor consolidation processes. This study aims to examine the influence of HIIE on sequential motor learning using PP or MI under both sleep-deprived and normal sleep conditions. Six groups, each comprising 12 participants, will learn an 8-item bimanual sequence. - MI group: acquired the motor sequence mentally during training - MI+HIIE group: acquired the motor sequence mentally and achieve a HIIE before the consolidation - PP: acquired the motor sequence physically - PP+HIIE group: acquired the motor sequence physically and achieve a HIIE before the consolidation - SD+PP group: one night of sleep deprivation prior physical motor acquisition with PP and consolidation - SD+PP+HIIE group: one night of sleep deprivation prior physical motor acquisition and HIIE before consolidation. All groups will be tested on the sequence at the beginning and the end of the acquisition phase (pre- and post-acquisition), and after the physical exercise (i.e. HIIE) or the rest period (post-exercise). Hypothesis of this study are : - Acute physical exercise (HIIE) would enhance the consolidation of motor memory (post-exercise) after physical and mental acquisition (PP,MI) compared to conditions without exercise. - One night of sleep deprivation would affect the acquisition and consolidation of motor learning. Physical exercise would compensate for the detrimental effects of sleep deprivation on the consolidation of motor learning.


Description:

The ability to learn new movement (i.e. motor learning) is an essential part of the human daily routine. Motor learning is typically characterized by an online acquisition phase followed by an offline consolidation phase (i.e., without further practice) whereby the motor memory traces are reorganized into stable and long-lasting representations. The acquisition can be achieved through physical practice (PP, overt repetition of the movement) or through motor imagery (MI, covert rehearsal of movement). Over the last two decades, studies have demonstrated that performing high intensity interval exercise (HIIE) can enhance motor learning and particularly the consolidation phase. It seems that HIIE induced a favourable physiological cascade that contributes to the neural plasticity. In this vein, both lactate and brain derived neurotrophic factor (BDNF) biological markers seems to play a major role in long-term memory consolidation. To date, little is known on the HIIE contribution to sequential motor consolidation with PP or MI. By contrast to HIIE, sleep deprivation decreased the BDNF released and the neural plasticity. There are very few studies that have examined the impact of sleep deprivation (SD) on motor acquisition and only one on sequence motor learning. Considering the antagonistic effects of HIIE and SD, it might possible that performing HIIE following SD could protect the motor consolidation processes. Therefore, the main goal of this study is to understand the influence of HIIE on sequential motor learning through PP or MI under condition of sleep deprivation and normal night. In this study, six groups will be enrolled each including 12 participants. All groups will learn a bimanual sequence of 8 items. - MI group: acquired the motor sequence mentally during training - MI+HIIE group: acquired the motor sequence mentally and achieve a HIIE before the consolidation - PP: acquired the motor sequence physically - PP+HIIE group: acquired the motor sequence physically and achieve a HIIE before the consolidation - SD+PP group: one night of sleep deprivation prior physical motor acquisition with PP and consolidation - SD+PP+HIIE group: one night of sleep deprivation prior physical motor acquisition and HIIE before consolidation. All groups will be tested on the sequence at the beginning and the end of the acquisition phase (pre- and post-acquisition), and after the physical exercise (i.e. HIIE) or the rest period (post-exercise). Hypothesis of this study are : - Acute physical exercise (HIIE) would enhance the consolidation of motor memory (post-exercise) after physical and mental acquisition (PP,MI) compared to conditions without exercise. - One night of sleep deprivation would affect the acquisition and consolidation of motor learning. - Physical exercise would compensate for the detrimental effects of sleep deprivation on the consolidation of motor learning.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date October 28, 2024
Est. primary completion date October 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Male or female aged 18 to 35 - Available for the entire study (13 days maximum) - Right-handed upper limbs with a score > 0.5 on the Edinburgh laterality test - Having dated and signed an informed consent - Subject affiliated or entitled to a social security scheme - Absence of contraindication to the practice of physical activity - Considered active according to the GPAQ (Global Physical Activity Questionnaire) - Neutral or moderate circadian typology (31 to 69) - Regular physical activity (2h/week minimum) Exclusion Criteria: - Musculoskeletal injury < 6 months - Pathology or surgical intervention resulting in a locomotor disorder < 6 months - Chronic or disabling neurological, cardiovascular or psychic pathology - Resting heart rate > 100 bpm - Pittsburgh Sleep Quality Index > 10 - Taking sleeping pills or medication with a psychoactive effect during the last 6 months - Ongoing participation in an interventional research - Pregnant or breastfeeding women - Person deprived of judicial or administrative freedom. - Contraindication to TMS (Transcranial Magnetic Stimulation): - Frequent or severe headaches - History of epilepsy - Head trauma with loss of consciousness - Implanted equipment (including implanted pacemaker or defibrillator, cochlear implant, pump administering medication, surgical clips, metal shrapnel) - Neurosurgical intervention (in particular eye surgery) - An open wound on the scalp - Consumption of more than three glasses of alcohol per day

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep Deprivation (SD)
Participants in the sleep deprivation group will spend a night awake, under the supervision of an investigator, at Croix-Rousse Hospital. The investigator will provide a list of activities to maintain the participant awake.
Normal Night (Night)
Participants in the normal night group will spend one night sleeping in their own home.
Physical Exercise (HIIE)
Participants in the physical exercise group (i.e. IM+HIIE, PP+HIIE, SD+PP+HIIE) will start with a 2-minute warm-up on an ergometer cycle. After the warm-up, they will perform 3 minutes of exercise at a workload customized to their maximal aerobic power (MAP) corresponding to 80 % their MAP and then rest actively for 2 minutes at 40 % of MAP. This cycle of 5 minutes will be repeated 3 times in row, resulting in a total of 17 minutes of physical exercise including the warm-up.
Rest control
Participants will watch a documentary during an equivalent time as the physical exercise (i.e. 17 minutes).
Motor imagery
On the bimanual finger tapping task composed of 8 elements, the participant will be required to repeat the motor sequence mentally using MI (mental rehearsal of movement) during twelve blocks of 30 seconds. Participant will imagine performing the sequence as fast and accurately as possible without overt movement.
Physical Practice (PP)
Participants will practice a bimanual sequential finger tapping task composed of 8 movements. Participant will be required to perform the sequence as fast and as accurately as possible during blocs of 30 s (i.e. twelve blocs during training).

Locations

Country Name City State
France Service d'explorations fonctionnelles respiratoires-Médecine du sport et de l'activité physique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon Lyon
France Laboratoire LIBM, Université Lyon 1 Villeurbanne

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of correct sequence between post-acquisition and post-exercise for PP and PP+HIIE In the bimanual finger tapping task, the accuracy corresponds to the number correct sequence performed during a block of practice The primary outcome measure will be the difference in the number of correct sequences performed between the end of acquisition (post-acquisition) and consolidation (post-exercise) stages between the PP and PP+HIIE. Through study completion, an average of 13 days.
Secondary Number of correct sequence between post-acquisition and post-exercise for IM and IM+HIIE In the bimanual finger tapping task, the accuracy corresponds to the number correct sequence performed during a block of practice.
This secondary outcome measure will be the difference in the number of correct sequences performed between the end of acquisition (post-acquisition) and consolidation (post-exercise) stages between the IM and IM+HIIE.
Through study completion, an average of 13 days.
Secondary Number of correct sequence between pre-acquisition, post-acquisition, and post-exercise for SD and SD+PP In the bimanual finger tapping task, the accuracy corresponds to the number correct sequence performed during a block of practice.
This secondary outcome measure will be the difference in the number of correct sequences performed between the beginning of the acquisition (pre-acquisition), the end of acquisition (post-acquisition) and the consolidation (post-exercise) stages between the SD and SD+PP groups.
Through study completion, an average of 13 days.
Secondary Number of correct sequence between post-acquisition and post-exercise for SD+PP and SD+PP+HIIE In the bimanual finger tapping task, the accuracy corresponds to the number correct sequence performed during a block of practice.
This secondary outcome measure will be the difference in the number of correct sequences performed between the end of acquisition (post-acquisition) and consolidation (post-exercise) stages between the SD+PP and SD+PP+HIIE groups.
Through study completion, an average of 13 days.
Secondary Neurophysiological informations between pre-acquisition, post-acquisition and post-exercise for all groups (IM, PP, IM+HIIE, PP+HIIE, SD+PP, SD+PP+HIIE) Neurophysiological measurement will be collected with transcranial magnetic stimulation (TMS). TMS is a tool that generate a magnetic field that depolarizes the neuron in primary motor cortex and offers the opportunity to probe the cortico-spinal excitability (CSE) through motor evoked potential (MEP).
To consider the muscle fibers excitability when analysing MEP amplitude, responses will be normalized to the maximal M-wave. The assessment of M-wave for the first dorsal interosseous muscle will be achieved with a single constant-current stimulation applied on the ulnar nerves via a 30-mm anode-cathode bipolar felt pad.
The average of MEP will be normalised to M wave using this formula :
MEP normalised=((Mean MEP (mV))/(Mean Mmax (mV) ))*100 The MEP Normalised will be compared for all groups between the three-time frame pre-acquisition, post-acquisition and post-exercise
Through study completion, an average of 13 days.
Secondary BDNF assessment between pre-acquisition and post-exercise for all groups Biological variables will include the measurement of three molecules: lactate, BDNF and cortisol.
A 5 ml blood sample will be collected from an antecubital vein and will be immediately centrifuged. The plasma will be separated from the serum and stored at -80 °C. BDNF(brain-derived neurotrophic factor) levels will be analysed by means of enzyme-linked immunosorbent assay method (ELISA Kit) at the end of study.
BDNF will be compared for all groups between the two-time frames pre-acquisition and post-exercise
Through study completion, an average of 13 days.
Secondary Lactate assessment between pre-acquisition and post-exercise for all groups Biological variables will include the measurement of three molecules: lactate, BDNF and cortisol.
Blood lactate will be collected from a capillary blood on the finger and will be immediately analysed using a lactate analyser device.
Lactate will be compared for all groups between the two-time frames pre-acquisition and post-exercise
Through study completion, an average of 12 days.
Secondary Cortisol assessment between pre-acquisition and post-exercise for all groups Biological variables will include the measurement of three molecules: lactate, BDNF and cortisol.
A 5 ml blood sample will be collected from an antecubital vein and will be immediately centrifuged. The plasma will be separated from the serum and stored at -80 °C. Cortisol levels will be analysed by means of enzyme-linked immunosorbent assay method (ELISA Kit) at the end of study.
Cortisol will be compared for all groups between the two-time frames pre-acquisition and post-exercise
Through study completion, an average of 13 days.
Secondary Number of correct sequence between post-acquisition and post-exercise for PP and MI groups In the bimanual finger tapping task, the accuracy corresponds to the number correct sequence performed during a block of practice.
This secondary outcome measure will be the difference in the number of correct sequences performed between the end of acquisition (post-acquisition) and consolidation (post-exercise) stages between the PP and MI groups.
Through study completion, an average of 13 days.
Secondary Number of correct sequence between post-acquisition and post-24h for all groups In the bimanual finger tapping task, the accuracy corresponds to the number correct sequence performed during a block of practice.
This secondary outcome measure will be the difference in the number of correct sequences performed between the end of acquisition (post-acquisition) and the next day after a night's sleep (post-24h) for all groups.
Through study completion, an average of 13 days.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04439097 - Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease N/A
Completed NCT04612127 - Efficacy of the Consumption of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age N/A
Completed NCT05938634 - A Randomized Controlled Trial Using Stage-matched Intervention Based on the Transtheoretical Model of Change to Enhance Engaging in Regular Physical Exercise Among High School Female Students. N/A
Recruiting NCT06091384 - Inspiratory Muscle Strength Training in Post-Covid Syndrome N/A
Enrolling by invitation NCT04651140 - Research on the Effect and Mechanism of Aerobic Exercise on PD N/A
Completed NCT04251611 - Randomized Clinical Trial by Conglomerates on the Efficacy of Maintenance of Physical Exercise in Myocardial Ischemia N/A
Completed NCT03415880 - Light Intensity Physical Activity Trial N/A
Active, not recruiting NCT05698472 - A Study on the Status Quo of Physical Exercise for the Elderly
Completed NCT04345237 - Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine N/A
Not yet recruiting NCT04822896 - Acute Effects of Motor Imagery and Physical Exercise on Tongue Strength and Pain Threshold in Healthy Adults N/A
Recruiting NCT06270667 - Effects of Exercise Training in Survivors of Lymphoma N/A
Recruiting NCT06370546 - Cardiac Response to Strength Training in Hypertensive Individuals N/A
Completed NCT03385837 - Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients
Completed NCT04024280 - Effects of a Physical Exercise Program in Quality of Life of Breast Cancer Survivors N/A
Completed NCT03517293 - Enhanced Neonatal Health and Neonatal Cardiac Effect Developmentally N/A
Recruiting NCT05726474 - Comparison of the Effect of Two Types of Physical Exercises in Patients With Heart Failure With Preserved Ejection Fraction N/A
Completed NCT04243174 - The Use of Short SMS Messaging With Type 2 Diabetes (T2DM) N/A
Terminated NCT04234009 - Lifestyle and Brain Vascular Function N/A
Recruiting NCT04506840 - Physical Activity and Motivation in Colorectal Cancer Patients N/A
Not yet recruiting NCT06317753 - Can Exercise Rewire the Brain Addiction Circuitry? N/A