Evaluation of the Effect of a Clinical Exercise Programme on Plantar Distribution and Correction of Postural Asymmetries

October 16, 2024 updated by: Svitlana Dikhtyarenko, University of Beira Interior

Predicting Body Pain by Postural Related Problems in Middle-age and Older Adults Using Machine Learning

The aim of this study was to identify significant variables that contribute to the association between postural problems, plantar pressure distribution and levels of bodily pain in middle-aged and elderly adults. The researchers' hypothesis is that plantar pressure characteristics and postural asymmetries differ according to gender, are related to body composition and predict pain levels. The study described here is the only one to include variables that make it possible to identify body asymmetries in a postural analysis, based on the distribution of plantar pressure and body composition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study employed an observational cross-sectional design. A convenience sample was recruited to analyse differences between men and women in anthropometrics, body composition, plantar pressure distribution, and pain levels. Without intervention, researchers observed and recorded data at a single time point, allowing comparisons between sexes and exploring correlations among the measured variables. This type of design allowed a snapshot view of the differences and associations present within the sample.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

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

  • Portugal
    • Rua Das Areias, 11 - 2
      • Setúbal, Rua Das Areias, 11 - 2, Portugal, 2910-407
        • Svitlana Dikhtyarenko

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The population of the present study consisted of 52 (n=52) participants of both sexes. The majority of study participants were female, comprising 67.3% (n=35), while 32.7 % of the sample were male (n=17). The mean age of participants was 57.35 years in males and 64.69 years in females.

Description

Inclusion criteria:

  • Participants had to be at least eighteen years old and physically fit. All participants had to complete the PAR-Q (health questionnaire), psychological well-being questionnaire (EBEP) and sign the free, informed and informed consent form (CLIE).

Exclusion criteria:

  • In order to reduce the risk of injury or aggravation of known diseases, the researchers chose the following exclusion criteria: serious orthopaedic problems (prosthesis fitting, recent orthopaedic surgery), reported neurological problems (requiring daily medication), cardiopulmonary diseases (pacemaker, use of oxygen cylinders) and pregnant women.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
I
The 'M' point is on the heels of both feet.
Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.
II
The 'M' point is located on the heel of the left foot and the forefoot of the right foot.
Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.
III
Point 'M' is located on the heel of the right foot and the forefoot of the left foot.
Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.
IV
The point of maximum pressure is in the forefoot area of both feet.
Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.
V
The 'M' point is in the medial zone on both feet.
Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.
VI
The 'M' point is located on the left midfoot and right rearfoot.
Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.
VII
The 'M' point is located on the right midfoot and left rearfoot.
Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Importance and benefits of physical exercise in preventing pain and improving quality of life
Time Frame: 12 weeks
Sequencing of the training plan
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bodily pain and discomfort
Time Frame: 12 weeks
Relationship between posture and pain
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Significant changes in baropodometry images
Time Frame: 12 weeks
Physical exercise and changes in footsteps
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Beira Interior

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pedro Mr Forte, PhD, University of Beira Interior
  • Study Director: Dulce Ms Esteves, PhD, University os Beira Interior

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CE-UBI-Pj-2023-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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