Clinical trial NCT06647355: Evaluation of the Effect of a Clinical Exercise Programme on Plantar Distribution and Correction of Postural Asymmetries
Official title: Predicting Body Pain by Postural Related Problems in Middle-age and Older Adults Using Machine Learning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: This Study Highlights Differences in Baropodometry Between Genders
Keywords: Baropodometry, Bioimpedance, Artificial Intelligence
Lead sponsor: University of Beira Interior
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Importance and benefits of physical exercise in preventing pain and improving quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: Bodily pain and discomfort
timeFrame: 12 weeks
Other outcomes:
measure: Significant changes in baropodometry images
timeFrame: 12 weeks
Locations:
city: Setúbal
country: Portugal
facility: Svitlana Dikhtyarenko
state: Rua Das Areias, 11 - 2
Study officials:
affiliation: University of Beira Interior
name: Pedro Mr Forte, PhD
role: STUDY_DIRECTOR
affiliation: University os Beira Interior
name: Dulce Ms Esteves, PhD
role: STUDY_DIRECTOR
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