NCT06647355

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 6, 2024

Last Update Submit

October 16, 2024

Conditions

Keywords

Baropodometry, Bioimpedance, Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • Importance and benefits of physical exercise in preventing pain and improving quality of life

    Sequencing of the training plan

    12 weeks

Secondary Outcomes (1)

  • Bodily pain and discomfort

    12 weeks

Other Outcomes (1)

  • Significant changes in baropodometry images

    12 weeks

Study Arms (7)

I

The 'M' point is on the heels of both feet.

Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution

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

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

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

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

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

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

Interventions

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.

IIIIIIIVVVIVII

Eligibility Criteria

Age18 Years - 92 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Svitlana Dikhtyarenko

Setúbal, Rua Das Areias, 11 - 2, 2910-407, Portugal

Location

Study Officials

  • Pedro Mr Forte, PhD

    University of Beira Interior

    STUDY DIRECTOR
  • Dulce Ms Esteves, PhD

    University os Beira Interior

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student, Principal Investigador

Study Record Dates

First Submitted

October 6, 2024

First Posted

October 17, 2024

Study Start

October 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

October 17, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations