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Pediatric ObesityNCT06419829

Physical Activity, Posture and Body Composition in Ontogeny

An observational study of Pediatric Obesity and Postural Balance, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The main aim of the research is to assess the impact of various forms of physical activity on body composition and posture. The basis of the research is the assessment of the current condition of people of different ages and the development of individualized physioprophylaxis programs for body posture and body weight… Read more about this study

Who is it for?
Ages Up to 90 yearsHealthy volunteers can take part
What is being tested?
psychoprophylactic program aimed at normalizing body weight through medical training, psychoprophylactic program aimed at improving body posture and psychoprophylactic program aimed at improving physical fitness
How many people
1,000 participants
Where
1 sitePoland
Study dates
15 Jan 2023to 31 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The study group will be recruited from people living in the city of Wrocław and Lower Silesia from primary medical care centers, educational centers - kindergartens, and randomly selected primary schools. The Adult Group consists of people attending randomly selected secondary schools and various universities. The ej group will also include non-students recruited by invitation to participate in the research. The group of adults consists of people recruited on the basis of an open invitation carried out via social media, health facilities and large workplaces. The senior group will be recruited on the basis of an invitation addressed to senior activation centers

Who may be able to join

  • Informed written consent to participate in research and physical activity project of the examined person or his/her parent or legal guardian
  • There are no health contraindications to physical activity
  • no contraindications to the use of the bioelectrical impedance method (pacemaker, active cancer, pregnancy, metal elements in the body)

Who cannot join

  • Remaining under the care of the Awad Postway correction clinic active therapeutic process of weight reduction
  • being under the care of a cardiology clinic due to heart and/or circulatory system diseases - high blood pressure
  • Condition after injuries to the spine,
  • Orthopedic equipment - orthoses, prostheses, splints, crutches, walking aids
  • lack of contact with the patient, impaired cognitive functions, inability to understand instructions when working in a group
  • Diseases of the central nervous system
  • Parkinson's disease, advanced senile dementia

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Faculty of Physiotherapy, Department of Human Biology

    Wroclaw, Lower Silesian Voivodeship, 51-612

Other trials in Poland

About this study

Official title: The Impact of Targeted Physical Activity on Body Composition, Posture and Physical Fitness of People of Different Ages

The main aim of the research is to assess the impact of various forms of physical activity on body composition and posture. The basis of the research is the assessment of the current condition of people of different ages and the development of individualized physioprophylaxis programs for body posture and body weight abnormalities. In the senior group, the task of physioprophylactic programs is to prevent the loss of muscle mass, prevent falls and improve the quality of life.

Read the detailed description

The research is focused on three age groups: research in the progressive period of ontogenesis from 3 to 18 years of age, people in adulthood, and people in senior age, i.e. postmenopausal women and men over 65 years of age. The research is conducted in three stages - in the first stage: assessment of the current condition, i.e. body weight and composition, assessment of body posture, physical fitness (including age-appropriate tests), assessment of physical activity (IPAQ test, PAQ-C and PAQ-A test). ). In the second stage: development and implementation of physioprophylactic programs aimed at preventing overweight or obesity, body posture abnormalities, and reduced physical fitness. Physioprophylactic projects based on medical training are adapted to age and gender and the assessment of the current condition. The duration of the training project is 12 weeks, classes will be held twice a week for 60 minutes for adults, twice a week for 45 minutes for children over 7 years of age and twice a week for 30 minutes for preschool children. Physioprophylactic classes will complement school classes for the group under 18 years of age. The third part of the research project is the assessment of changes in body weight, body posture and physical fitness.

The practical part will be complemented by meetings and lectures for the respondents and their parents (in the case of children) regarding the importance of physical activity, diet and physical fitness in the quality of life and its importance in various periods of ontogenetic development.

The study of a given group will be completed with a follow-up study 6 months after the end of the research project The ongoing research project will allow the development of physioprophylactic programs with elements of medical training to counteract lifestyle diseases.

Being tested
psychoprophylactic program aimed at normalizing body weight through medical training, psychoprophylactic program aimed at improving body posture, psychoprophylactic program aimed at improving physical fitness, Body composition assessment, assessment of body posture using the Kasperczyk method
Keywords
overweight and obesity, body posture, children's activity and physical fitness, activity and physical fitness of seniors, physioprophylaxis for falls
Medical subject headings
Pediatric Obesity, Motor Activity, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • psychoprophylactic program aimed at normalizing body weight through medical trainingOther

    Based on the assessment of body weight and composition, a 12-week physiophylactic program will be carried out, adapted to the age and gender of the subjects. The program will be carried out twice a week for 30 to 60 minutes (depending on the group). The basis of the program will be the implementation of exercises that reduce fat mass, increase the flexibility and productivity of muscle mass. The classes will be conducted as part of medical training with a training load increasing to at least 85% of HR Max.

    The project will include theoretical classes for parents, children and seniors on eating habits, a proper age-appropriate diet, diet changes depending on the subject's health condition and physical activity, and the impact of diet on the process of puberty, adulthood and aging.

  • psychoprophylactic program aimed at improving body postureOther

    Based on the body posture assessment, a 12-week physiotherapy program will be carried out, adapted to the age and gender of the subjects. The program will be carried out twice a week for 30 to 60 minutes (depending on the group). The basis of the program will be the implementation of exercises that strengthen the muscle corset, reducing asymmetrical positioning, habitual and during the implementation of professional tasks. The classes will be conducted using medical training and resistance exercises.

    The project will include theoretical classes for parents on sitting habits, the importance of physical activity in a child's development, the selection of footwear...

  • psychoprophylactic program aimed at improving physical fitnessOther

    Based on the assessment of physical fitness, a 12-week physiotherapy program will be carried out, adapted to the age and gender of the participants. The program will be carried out twice a week for 30 to 60 minutes (depending on the group). The basis of the program will be the implementation of exercises aimed at improving physical fitness, with particular emphasis on impaired motor skills. The classes will be conducted using functional training, resistance and stretching exercises, strengthening all muscle groups. In the case of children, special attention will be paid to the strength of the upper limbs, in the case of seniors, balance and coordination exercises will be introduced to improve time and space orientation. In all groups, the main goal is to improve functional fitness The project will include theoretical classes for parents, children and seniors on the importance of physical activity in the quality of life, in the process of maturation and aging.

  • Body composition assessmentDiagnostic test

    Body composition assessment will be carried out using the BIA method on an eight-electrode body composition analyzer from TAnita. They will be marked:

    total mass, Total fat mass (FM) and segmental fat mass for five body segments: right leg (RL FM), Left leg (LL FM), right arm (RA FM), Left Arm (LA FM) trunk (TR FM).

    total fat-free mass (FFM) and segmental for five body segments: right leg (RL FFM), Left leg (LL FFM), right arm (RA FFM), Left Arm (LA FMM) trunk (TR FMM).

    Predicted total and segmental muscle mass (PMM) for five body segments: right leg (RL PMM), Left leg (LL PMM), right arm (RA PMM), Left Arm (LA PMM) trunk (TR PMM).

    Total water content (TBW) including intracellular water (ICW) and extracellular water (ECW)

  • assessment of body posture using the Kasperczyk methodDiagnostic test

    The Kasperczyk method was used to assess body posture, including physiotherapeutic assessment in both standing and sitting positions. The symmetry of the head, shoulders, spine curvatures, knee joints and foot positioning were assessed. The symmetry of the head position was examined in all three planes and in all movements, i.e. flexion - extension, right turn - left turn, rotation and combined movements. The lateral curvatures of the spine (scoliosis) and their physiological curvatures, their deepening or shallowing in all sections of the spine, as well as the mobility of the spine in all physiological planes of movement were assessed. The position of the shoulder and hip girdle was assessed, as well as the position of the upper limbs at the level of the knees and feet. The mobility of the lower and upper limbs was examined.

  • Assessment of physical fitnessDiagnostic test

    It depends on the age of the person being examined. In the case of children, the EUROFIT physical fitness test is carried out with modifications for age and gender. For the senior group, the Rikli and Jones test is used

  • Balance assessmentDiagnostic test

    Balance assessment using the Zebris platform Static measurement - with eyes open and closed, assessing the load on the limbs during standing expressed in %, Balance analysis measurement - with eyes open and closed, test in a standing position, barefoot. The measurement duration is 30 seconds and the break between measurements is 30-60 seconds.

    Deflections of the center of gravity in the frontal and sagittal planes Length of the center of gravity swing path CoP - SPL [cm]. Inside the calculated ellipse lies 95% of the CoP location measurement data: amplitude, amplitude height, ellipse area (orientation of the direction of the ellipse's longitudinal axis relative to the platform's longitudinal axis, indicating clockwise rotation).

Study groups in NCT06419829
Study groupRoleWhat they receive
Pediatric groupPediatric group - children aged 0-3 years old, participating in physiotherapeutic visits carried out as part of the assessment of the child's psychomotor development
Receives: Other: psychoprophylactic program aimed at improving physical fitness; Diagnostic Test: assessment of body posture using the Kasperczyk method
Pediatric older groupPediatric older group - Children aged 3-6 years recruited as part of pre-school education
Receives: Other: psychoprophylactic program aimed at normalizing body weight through medical training; Other: psychoprophylactic program aimed at improving body posture; Other: psychoprophylactic program aimed at improving physical fitness; Diagnostic Test: Body composition assessment; Diagnostic Test: assessment of body posture using the Kasperczyk method; Diagnostic Test: Assessment of physical fitness; Diagnostic Test: Balance assessment
School groupSchool group - Children aged 7-15 recruited as part of compulsory schooling at primary school level
Receives: Other: psychoprophylactic program aimed at normalizing body weight through medical training; Other: psychoprophylactic program aimed at improving body posture; Other: psychoprophylactic program aimed at improving physical fitness; Diagnostic Test: Body composition assessment; Diagnostic Test: assessment of body posture using the Kasperczyk method; Diagnostic Test: Assessment of physical fitness; Diagnostic Test: Balance assessment
Youth groupRespondents aged 15-25 recruited as part of secondary education, taking into account age (secondary school, university, graduate school) and gender division
Receives: Other: psychoprophylactic program aimed at normalizing body weight through medical training; Other: psychoprophylactic program aimed at improving body posture; Other: psychoprophylactic program aimed at improving physical fitness; Diagnostic Test: Body composition assessment; Diagnostic Test: assessment of body posture using the Kasperczyk method; Diagnostic Test: Assessment of physical fitness; Diagnostic Test: Balance assessment
Adult groupAdult group - Respondents aged 25-55
Receives: Other: psychoprophylactic program aimed at normalizing body weight through medical training; Other: psychoprophylactic program aimed at improving physical fitness; Diagnostic Test: Body composition assessment; Diagnostic Test: Assessment of physical fitness; Diagnostic Test: Balance assessment
Senior groupSenior group - Tests at the age of over 55, in the case of women, the condition for inclusion in this group is the postmenopausal period
Receives: Other: psychoprophylactic program aimed at normalizing body weight through medical training; Other: psychoprophylactic program aimed at improving body posture; Other: psychoprophylactic program aimed at improving physical fitness; Diagnostic Test: Body composition assessment; Diagnostic Test: assessment of body posture using the Kasperczyk method; Diagnostic Test: Assessment of physical fitness; Diagnostic Test: Balance assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A physioprophylactic program for children aimed at normalizing body weight, improving physical fitness and correcting body posture

    The result of the project will be the development of physioprophylactic programs based on medical training aimed at normalizing body weight, improving and correcting body posture and improving physical fitness. The programs will be adapted to the problems diagnosed in control tests and the age and gender of the examined children and adolescents Their final effectiveness will be assessed during follow-up tests performed immediately after the end of the 12-week program and follow-up tests after 6 months.

    Measured: 01.2027-12.2027

  2. Physiophylaxis in adulthood

    The result of the preliminary tests will be an estimate of the scale of occurrence of body weight abnormalities and body posture abnormalities, which are not monitored during this period. An important cognitive element will also be the assessment of the physical fitness of adults, taking into account their age, gender, body weight, forms of work undertaken, and exposure to stress.

    Their final effectiveness will be assessed during follow-up tests performed immediately after the end of the 12-week program and follow-up tests after 6 months.

    Measured: 01.2026-06.2027

  3. Physiophylaxis in seniors

    The result of the preliminary tests will be an estimate of the scale of occurrence of body weight abnormalities and body posture abnormalities, which are not monitored during this period. The physioprophylactic programs carried out will enable the development of standardized training programs aimed at improving the elderly's physical fitness, preventing falls, and maintaining the functionality and independence of older people. An important cognitive element will also be the assessment of the physical fitness of seniors, taking into account their age, gender, body weight, previously undertaken forms of work, exposure to stress, and quality of life.

    Their final effectiveness will be assessed during follow-up tests performed immediately after the end of the 12-week program and follow-up tests after 6 months.

    Measured: 01.2028-12.2028

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2024
  2. Study start15 Jan 2023
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06419829
Sponsor's protocol ID
AChwalWUHSS
Status last verified
May 2024
First submitted
8 May 2024
Last updated
17 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric Obesity and Postural Balance, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A physioprophylactic program for children aimed at normalizing body weight, improving physical fitness and correcting body posture (time frame: 01.2027-12.2027). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.

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