## Protocol Section
### Identification Module
**NCT ID:** NCT06419829

**Brief Title:** Physical Activity, Posture and Body Composition in Ontogeny

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

#### Organization Study ID Info
**ID:** AChwalWUHSS
#### Organization
**Class:** OTHER
**Full Name:** Wroclaw University of Health and Sport Sciences
### Status Module
#### Completion Date
**Date:** 2029-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2028-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-01-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Wroclaw University of Health and Sport Sciences

#### Responsible Party

**Investigator Affiliation:** Wroclaw University of Health and Sport Sciences

**Investigator Full Name:** Agnieszka Chwalczynska

**Investigator Title:** PhD, Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Pediatric Obesity

- Postural Balance

- Physical Activity

**Keywords:**

- overweight and obesity

- body posture

- children's activity and physical fitness

- activity and physical fitness of seniors

- physioprophylaxis for falls

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Other: psychoprophylactic program aimed at improving physical fitness

- Diagnostic Test: assessment of body posture using the Kasperczyk method

**Label:** Pediatric group

#### Arm Group 2

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

**Intervention Names:**

- 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

**Label:** Pediatric older group

#### Arm Group 3

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

**Intervention Names:**

- 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

**Label:** School group

#### Arm Group 4

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

**Intervention Names:**

- 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

**Label:** Youth group

#### Arm Group 5

**Description:** Adult group - Respondents aged 25-55

**Intervention Names:**

- 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

**Label:** Adult group

#### Arm Group 6

**Description:** 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

**Intervention Names:**

- 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

**Label:** Senior group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Adult group

- Pediatric older group

- School group

- Senior group

- Youth group

**Description:** 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.

**Name:** psychoprophylactic program aimed at normalizing body weight through medical training

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Pediatric older group

- School group

- Senior group

- Youth group

**Description:** 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...

**Name:** psychoprophylactic program aimed at improving body posture

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Adult group

- Pediatric group

- Pediatric older group

- School group

- Senior group

- Youth group

**Description:** 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.

**Name:** psychoprophylactic program aimed at improving physical fitness

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Adult group

- Pediatric older group

- School group

- Senior group

- Youth group

**Description:** 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)

**Name:** Body composition assessment

**Type:** DIAGNOSTIC_TEST

#### Intervention 5

**Arm Group Labels:**

- Pediatric group

- Pediatric older group

- School group

- Senior group

- Youth group

**Description:** 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.

**Name:** assessment of body posture using the Kasperczyk method

**Type:** DIAGNOSTIC_TEST

#### Intervention 6

**Arm Group Labels:**

- Adult group

- Pediatric older group

- School group

- Senior group

- Youth group

**Description:** 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

**Name:** Assessment of physical fitness

**Type:** DIAGNOSTIC_TEST

#### Intervention 7

**Arm Group Labels:**

- Adult group

- Pediatric older group

- School group

- Senior group

- Youth group

**Description:** 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).

**Name:** Balance assessment

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** A physioprophylactic program for children aimed at normalizing body weight, improving physical fitness and correcting body posture

**Time Frame:** 01.2027-12.2027

**Description:** 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.

**Measure:** Physiophylaxis in adulthood

**Time Frame:** 01.2026-06.2027

**Description:** 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.

**Measure:** Physiophylaxis in seniors

**Time Frame:** 01.2028-12.2028

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

**Healthy Volunteers:** True

**Maximum Age:** 90 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Wrocław

**Country:** Poland

**Facility:** Faculty of Physiotherapy, Department of Human Biology

**State:** Dolnośląskie

**Zip:** 51-612

#### Overall Officials

**Official 1:**

**Affiliation:** Wroclaw Uniwersity of Health and Sport Sciences

**Name:** AGNIESZKA CHWAŁCZYŃSKA, PROF

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009765

- Term: Obesity

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M30155

- Name: Pediatric Obesity

- Relevance: HIGH

- As Found: Pediatric Obesity

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000063766

- Term: Pediatric Obesity

### Misc Info Module

- Version Holder: 2024-05-31
