- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04548323
Hypoalgesic Effects of Walking and Running Imagined
September 7, 2020 updated by: Roy La Touche Arbizu, Universidad Autonoma de Madrid
Hypoalgesic Effects of Walking and Running Imagined in Sedentary Subjects and With High Levels of Physical Activity: A Prospective Cohort Study
The main objective is to identify the hypoalgesic effect of the imagination of actions in sedentary subjects with high levels of physical activity.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Madrid, Spain, 28023
- CSEU La Salle
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy subjects divided by their physical activity levels.
Description
Inclusion Criteria:
- asymptomatic participants
- men and women aged 18 to 65 years
Exclusion Criteria:
- insomnia
- nausea
- headache
- pregnancy
- use of painkillers in the last 24 hours
- presence of metal inside the head
- pacemaker
- wound on the area of electrodes' application
- drug consumption; (j) recent application of tDCS
- psychiatric disease impeding understanding of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Motor Imagery in Sedentary subjects
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Subjects will perform motor imagery tasks on the motor gestures of running and walking.
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Motor Imagery active subjects
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Subjects will perform motor imagery tasks on the motor gestures of running and walking.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain pressure threshold
Time Frame: Change from baseline and immediately post-intervention
|
Pressure Pain Threshold (PPT) is one of these tests and it is defined as the minimum force applied which induces pain.
The measurement shall be carried out by using an algometer (pressure device that induces mechanical stimuli) is to standardize the amount of pressure applied in the neck region.
The reliability of pressure pain thresholds according to raters or measurement frequencies is relatively high
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Change from baseline and immediately post-intervention
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Temporal sumation
Time Frame: Change from baseline and immediately post-intervention
|
Temporal summation is a somatosensory measure that is performed by making small punctures in the area of interest.
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Change from baseline and immediately post-intervention
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Electrodermal activity
Time Frame: Change from baseline and immediately post-intervention
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Electrodermal Activity will be measured through the use of two electrodes that recorded changes in conductance through the skin located at the back of the dominant hand
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Change from baseline and immediately post-intervention
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Respiration Rate
Time Frame: Change from baseline and immediately post-intervention
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Respiration Rate will be measured through a pressure transducer located in the centre of the chest, where it was fixed by a strap.
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Change from baseline and immediately post-intervention
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Heart rate
Time Frame: Change from baseline and immediately post-intervention.
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Heart Rate will be measured by three electrodes located in the left area of the chest.
One of the electrodes was placed in the middle zone while a second electrode was positioned on the lateral side, and a third one on the lower left side, below the first electrode.
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Change from baseline and immediately post-intervention.
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Salivary stress
Time Frame: Change from baseline and immediately post-intervention.
|
The Salivary Stress Test is a study that assesses fatigue and the type of stress (acute, moderate or chronic) presented by the subject.
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Change from baseline and immediately post-intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The degree of physical activity
Time Frame: Immediately before the intervention.
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The degree of physical activity was objectified through the The International Physical Activity Questionnaire (IPAQ) questionnaire, which allows the subjects to be divided into three groups according to their level of activity, which can be high, moderate, and low or inactive.
The IPAQ consists of 7 questions about the frequency, duration and intensity of activity (moderate and intense) performed in the last seven days, as well as walking and sitting time on a workday.
The IPAQ scoring protocol assigns the following MET values to walking, moderate, and vigorous intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively.
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Immediately before the intervention.
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Visual and Kinesthetic Motor Imagery Ability
Time Frame: Change from baseline and immediately post-intervention
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Visual and Kinesthetic Motor Imagery Ability will be measured with Movement Imagery Questionnaire-Revised (MIQ-R).
MIQ-R has four movements repeated in two subscales, a visual and a kinesthetic one.
Additionally, a score between 1 and 7 is assigned, with 1 representing difficulty in picturing the motor image or difficulty in feeling the movement previously made, and 7 representing the maximum ease.
The internal consistencies of the MIQ-R have been consistently adequate with Cronbach's α coefficients ranging above 0.84 for the total scale, 0.80 for de visual subscale and 0.84 for the kinesthetic subscale.
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Change from baseline and immediately post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 30, 2020
Primary Completion (Anticipated)
December 30, 2020
Study Completion (Anticipated)
July 30, 2021
Study Registration Dates
First Submitted
September 7, 2020
First Submitted That Met QC Criteria
September 7, 2020
First Posted (Actual)
September 14, 2020
Study Record Updates
Last Update Posted (Actual)
September 14, 2020
Last Update Submitted That Met QC Criteria
September 7, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- uammadrid32
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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