NCT04973956

Brief Summary

In motor learning, to consider that movements are produced by the cooperation and combination of many brain structures and are influenced by the emotions to which individuals are subjected is essential. Several neural circuits have been identified that closely link the emotional system and the motion control system. Anxiety is defined by persistent and excessive worries that do not disappear even in the absence of the stressor. Anxiety has been found to produce inefficiencies in information processing, which can result in performance deficits, as well as self-reported anxiety has been linked to poorer working retrieval performance. In these stress and anxiety contexts, relaxation techniques have been widely used to reduce psychophysiological arousal levels. Understanding how movement, emotions and interactions are regulated is significant because of the large number of movements humans perform. Of these, manual tasks represent precise movements that require the integration of many elements by the nervous system to perform these tasks successfully. How anxiety influence the way manual tasks are learned is still unknown. On the other hand, motor imagery (MI) is a cognitive process that is an important contributor to how movements are planned and executed. The use of MI has been recommended to improve movement learning and task execution. Knowing MI capacity is essential for creating effective and individualized MI programs. However, how a relax intervention can affect the motor imagery ability in anxiety people is still unknown. The aim of our study was to find out whether a relaxation intervention prior to MI practice in subjects with anxiety can influence the learning of a precise manual task not previously trained on four parameters of fine motor control: time, error, speed, and accuracy. On the other hand, the aim is to determine if the ability of internal visual, external visual, and kinaesthetic imagery varies when the anxiety participants are subjected to relaxation. The investigators expect that participants with anxiety, to whom relaxation is induced, will show better motor performance on the fine motor task and better motor imagery ability. In contrast, the investigators expect that participants with anxiety, to whom relaxation is not induced, will show poorer motor performance on the fine motor task and poorer motor imagery ability.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Sep 2021

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 14, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

June 24, 2021

Last Update Submit

November 28, 2023

Conditions

Keywords

AnxietyMotor LearningMemoryMotor Imagery Ability

Outcome Measures

Primary Outcomes (6)

  • Trayectory error

    It shall be the sum of the error between each of the points defining the path of the circumference. Pixels squared shall be considered as the unit of length measurement. To be recorded and measured with MATLAB. To be recorded and measured with MATLAB.

    During manual task performance in acquisition, short-term retrieval, and long-term retrieval

  • Timing error

    It is the absolute value of the difference between the duration of 2 seconds requested from the subjects and the total time elapsed in the execution of the trajectory. It shall be expressed in seconds (s). It shall be recorded and measured using MATLAB.

    During manual task performance in acquisition, short-term retrieval, and long-term retrieval

  • Timing accuracy

    The ability of the subject to learn the task at the requested rate of 2 seconds per lap. It shall be expressed in square pixels per second. It shall be recorded and measured by MATLAB.

    During manual task performance in acquisition, short-term retrieval, and long-term retrieval

  • Task accuracy

    It shall be the ability of the subject to learn at any rate. It shall be expressed in pixels per second. It shall be recorded and measured by MATLAB.

    During manual task performance in acquisition, short-term retrieval, and long-term retrieval

  • Motor Imagery Capacity

    This will be measured using the Movement Imagery Questionnaire-3, differentiating between the kinaesthetic, external visual and internal visual imagination subscales, each scored on a Likert scale from 1 to 7.

    Before induction of acute stress and in the resting period between short-term and long-term retrieval after induction of acute stress

  • Discrepancy time

    It will be the difference between the execution times and imagery of the MIQ-3 items. It will be measured with a stopwatch by the experimenter.

    Before induction of acute stress and in the resting period between short-term and long-term retrieval after induction of acute stress

Secondary Outcomes (2)

  • Electrodermal Activity

    During the procedure

  • Heart Rate Variability

    During the procedure

Study Arms (2)

Relaxation group

ACTIVE COMPARATOR

This group will perform the APMR

Other: Relaxation

Control group

ACTIVE COMPARATOR

This group will perform the control intervention

Other: Control

Interventions

This group will perform the APMR. This intervention consists of a standardized 20 min session in which subjects are asked to sequentially tense and relax various muscle groups. To do so, participants will listen to an audio with relaxation instructions while seated in a reclining seat and dimmed lighting.

Relaxation group
ControlOTHER

No intervention

Control group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women between 18 and 35 years of age.
  • Normal or corrected vision specifying the method of correction.
  • Normal or corrected hearing specifying method of correction.
  • Unfamiliar with the assessment and uses of motor imagery.
  • Presence of State-Trait Anxiety Inventory scores corresponding to anxiety.

You may not qualify if:

  • Subjects who have suffered fractures, dislocations, or traumatic processes in any segment of the non-dominant upper limb or fingers, wrist, or elbow of the dominant upper limb in the last 6 months.
  • Subjects with learning disabilities or problems in reading or writing.
  • Subjects with a history of any neurological disease, cardiovascular disease, myopathic disease, epileptic seizure, absence seizure, sleep apnoea, chronic fatigue syndrome, or fibromyalgia.
  • Taking any medication to suppress anxiety, to sleep, antidepressants, antihistamines, muscle relaxants, psychotropic, or other medications that interfere with the nervous system.
  • Intake of nervous system depressants or stimulants such as caffeine or theine in the last 8 hours.
  • Presence of localised skin lesion or disease in the wrist area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Claude Bernard University Lyon 1

Villeurbanne, Auvergne-Rhône-Alpes, 69100, France

Location

University of Alcalá

Alcalá de Henares, Madrid, 28871, Spain

Location

Complutense University of Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

European University of Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

Location

Related Publications (8)

  • Coombes SA, Cauraugh JH, Janelle CM. Emotion and movement: activation of defensive circuitry alters the magnitude of a sustained muscle contraction. Neurosci Lett. 2006 Apr 3;396(3):192-6. doi: 10.1016/j.neulet.2005.11.048. Epub 2005 Dec 20.

    PMID: 16376016BACKGROUND
  • Moran TP. Anxiety and working memory capacity: A meta-analysis and narrative review. Psychol Bull. 2016 Aug;142(8):831-864. doi: 10.1037/bul0000051. Epub 2016 Mar 10.

    PMID: 26963369BACKGROUND
  • Doumas M, Morsanyi K, Young WR. Cognitively and socially induced stress affects postural control. Exp Brain Res. 2018 Jan;236(1):305-314. doi: 10.1007/s00221-017-5128-8. Epub 2017 Nov 14.

    PMID: 29138872BACKGROUND
  • MacIntyre TE, Madan CR, Moran AP, Collet C, Guillot A. Motor imagery, performance and motor rehabilitation. Prog Brain Res. 2018;240:141-159. doi: 10.1016/bs.pbr.2018.09.010. Epub 2018 Oct 24.

    PMID: 30390828BACKGROUND
  • Schuster C, Hilfiker R, Amft O, Scheidhauer A, Andrews B, Butler J, Kischka U, Ettlin T. Best practice for motor imagery: a systematic literature review on motor imagery training elements in five different disciplines. BMC Med. 2011 Jun 17;9:75. doi: 10.1186/1741-7015-9-75.

    PMID: 21682867BACKGROUND
  • Trapero-Asenjo S, Gallego-Izquierdo T, Pecos-Martin D, Nunez-Nagy S. Translation, cultural adaptation, and validation of the Spanish version of the Movement Imagery Questionnaire-3 (MIQ-3). Musculoskelet Sci Pract. 2021 Feb;51:102313. doi: 10.1016/j.msksp.2020.102313. Epub 2020 Dec 9.

    PMID: 33310512BACKGROUND
  • Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.

    PMID: 5146491BACKGROUND
  • Trapero-Asenjo S, Fernandez-Guinea S, Guillot A, Pecos-Martin D, Nunez-Nagy S. Muscle relaxation enhances motor imagery capacity in people with anxiety: A randomized clinical trial. PLoS One. 2025 Jan 10;20(1):e0316723. doi: 10.1371/journal.pone.0316723. eCollection 2025.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Sara T Trapero Asenjo, Master

    University of Alcala

    PRINCIPAL INVESTIGATOR
  • Susana N Núñez Nagy, PhD

    University of Alcala

    STUDY DIRECTOR
  • Sara F Fernández Guinea, PhD

    Universidad Complutense de Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The participant does not know what the other participants are doing, the researcher knows which study and group the subject is in, but only sets up the computerized presentations for each group and assigns folders within the computer that collects the data, thus avoiding a possible information bias, and finally, another researcher blind to the intervention will analyse the data to obtain the results.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: As participants complete the State-Trait Anxiety Inventory, and are found to be anxiety, they will be randomised in parallel to one of the two intervention groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD. Associate Professor of Physiotherapy

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 22, 2021

Study Start

September 14, 2021

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

December 4, 2023

Record last verified: 2023-11

Locations