NCT06419829

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress48%
Jan 2023Dec 2029

Study Start

First participant enrolled

January 15, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

6 years

First QC Date

May 8, 2024

Last Update Submit

May 14, 2024

Conditions

Keywords

overweight and obesitybody posturechildren's activity and physical fitnessactivity and physical fitness of seniorsphysioprophylaxis for falls

Outcome Measures

Primary Outcomes (3)

  • 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.

    01.2027-12.2027

  • 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.

    01.2026-06.2027

  • 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.

    01.2028-12.2028

Study Arms (6)

Pediatric group

Pediatric group - children aged 0-3 years old, participating in physiotherapeutic visits carried out as part of the assessment of the child's psychomotor development

Other: psychoprophylactic program aimed at improving physical fitnessDiagnostic Test: assessment of body posture using the Kasperczyk method

Pediatric older group

Pediatric older group - Children aged 3-6 years recruited as part of pre-school education

Other: psychoprophylactic program aimed at normalizing body weight through medical trainingOther: psychoprophylactic program aimed at improving body postureOther: psychoprophylactic program aimed at improving physical fitnessDiagnostic Test: Body composition assessmentDiagnostic Test: assessment of body posture using the Kasperczyk methodDiagnostic Test: Assessment of physical fitnessDiagnostic Test: Balance assessment

School group

School group - Children aged 7-15 recruited as part of compulsory schooling at primary school level

Other: psychoprophylactic program aimed at normalizing body weight through medical trainingOther: psychoprophylactic program aimed at improving body postureOther: psychoprophylactic program aimed at improving physical fitnessDiagnostic Test: Body composition assessmentDiagnostic Test: assessment of body posture using the Kasperczyk methodDiagnostic Test: Assessment of physical fitnessDiagnostic Test: Balance assessment

Youth group

Respondents aged 15-25 recruited as part of secondary education, taking into account age (secondary school, university, graduate school) and gender division

Other: psychoprophylactic program aimed at normalizing body weight through medical trainingOther: psychoprophylactic program aimed at improving body postureOther: psychoprophylactic program aimed at improving physical fitnessDiagnostic Test: Body composition assessmentDiagnostic Test: assessment of body posture using the Kasperczyk methodDiagnostic Test: Assessment of physical fitnessDiagnostic Test: Balance assessment

Adult group

Adult group - Respondents aged 25-55

Other: psychoprophylactic program aimed at normalizing body weight through medical trainingOther: psychoprophylactic program aimed at improving physical fitnessDiagnostic Test: Body composition assessmentDiagnostic Test: Assessment of physical fitnessDiagnostic Test: Balance assessment

Senior group

Senior group - Tests at the age of over 55, in the case of women, the condition for inclusion in this group is the postmenopausal period

Other: psychoprophylactic program aimed at normalizing body weight through medical trainingOther: psychoprophylactic program aimed at improving body postureOther: psychoprophylactic program aimed at improving physical fitnessDiagnostic Test: Body composition assessmentDiagnostic Test: assessment of body posture using the Kasperczyk methodDiagnostic Test: Assessment of physical fitnessDiagnostic Test: Balance assessment

Interventions

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.

Adult groupPediatric older groupSchool groupSenior groupYouth group

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...

Pediatric older groupSchool groupSenior groupYouth group

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.

Adult groupPediatric groupPediatric older groupSchool groupSenior groupYouth group

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)

Adult groupPediatric older groupSchool groupSenior groupYouth group

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.

Pediatric groupPediatric older groupSchool groupSenior groupYouth group

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

Adult groupPediatric older groupSchool groupSenior groupYouth group
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).

Adult groupPediatric older groupSchool groupSenior groupYouth group

Eligibility Criteria

AgeUp to 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy, Department of Human Biology

Wroclaw, Lower Silesian Voivodeship, 51-612, Poland

Location

MeSH Terms

Conditions

Pediatric ObesityMotor ActivityOverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • AGNIESZKA CHWAŁCZYŃSKA, PROF

    Wroclaw Uniwersity of Health and Sport Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Associate Professor

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 17, 2024

Study Start

January 15, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations