ClinicalTrials.gg
CompletedNCT07304622Updated Dec 26, 2025

Impact of Various Therapeutic Methods on Gait Quality, Physical and Mental Fitness of Postmenopausal Women.

An interventional study of Coordination Training and Core Training in Physical Performance and Fitness in Old Age, sponsored by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz. Completed at 1 site in Poland. Open to female participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Oct 2024, registered Dec 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
65 Years and older
Sex
Female
01

Study summary

The goal of this clinical trial is to learn which physical activity affects the quality of gait, physical and mental fitness of older women. The main questions it aims to answer are:

Does any of the training methods improve the physical or mental fitness of postmenopausal women? Which of these training methods improves the physical and mental condition of postmenopausal women the most?

Researchers will compare the results of three training groups to each other and to control group (with no training) to see which training method has the greatest impact on improving the quality of gait, physical fitness and mental health of postmenopausal women.

Participants took part in physical activity classes that took place for 12 weeks, twice a week for 45 minutes.

Before starting the first and after completing the last physical activity, participants participated in the following tests: resting circulatory parameters, anthropometric tests, respiratory spirometry, cardiorespiratory fitness assessment, Fullerton test, measurement of force distribution and foot pressure, physical activity level assessment (IPAQ), and questionnaires on health-related quality of life (SF-36), geriatric depression scale (GDS), and cognitive function assessment scale (MoCA).

Read the detailed description

The study aims to comprehensively evaluate three therapeutic methods and their impact on gait quality, physical fitness, and mental well-being. It will allow for the identification of gait patterns, the determination of parameter values separately for the left and right legs, enabling the assessment of gait symmetry, and may indicate injury or pain in the subject, even if these are not yet visible to the observer.

The study group consisted of 100 women over 65 years of age. Each of the three therapeutic methods was represented by 25 participants. The control group, which received no intervention, also consisted of 25 participants. Participants eligible for the project must have no health contraindications to participating in physical activity. Participation in the project is voluntary, and participants may withdraw from participation at any stage.

The three therapeutic methods (interventions) are:

  • "Mobility" (with yoga elements) - aimed at improving joint range of motion
  • "Coordination and Balance" - aimed at improving motor coordination and balance
  • "Core Stability" - aimed at strengthening abdominal, back, and hip muscles

Before the first and after the last exercise class, the following tests was performed:

  • resting circulatory system measurements (blood pressure and heart rate),
  • anthropometric tests Basic anthropometric measurements was taken (height, weight, selected circumferences, and measurements of the length and width of the trunk and limbs, and a body mass index (BMI) was calculated). Body composition was analyzed. Water content was measured using the bioimpedance method (BIA), which involves passing a very low-intensity, high-frequency current through the human body. The test was performed using a TANITA MC-980 MA device (TANITA, Japan). The test provides information on total body water (TBW), extracellular water (ECW), and intracellular water (ICW). The test is completely non-invasive.
  • respiratory spirometry It was performed using the Italian-made MicroQuark device by COSMED; for this purpose, in a sitting position, the women performed three tests during which static and dynamic spirometric parameters will be measured, such as: vital capacity (VC), expiratory reserve volume (ERV), tidal volume (VT), forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and the Tiffeneau index (FEV1/FVC); minute ventilation (VE) and maximum voluntary minute ventilation (MVV) will also be measured.
  • Fullerton test

It was used for a multidimensional assessment of physical fitness. It allows for the observation of gradual decline in fitness with age and assesses tolerance, strength, and flexibility of the upper and lower body, as well as agility and balance. The Fullerton Test consists of six sequentially performed parts:

Arm Curl Test Back Scratch Test 30-Second Chair Stand Chair Sit-and-Reach Test 8-Foot Up-and-Go Test 6-Minute Walk Test

  • measurement of force distribution and foot pressur (Lateral balance, foot force and load) Measurements of foot force and pressure distribution was made using a Tekscan MatScan measuring mat with built-in sensors. The test was performed dynamically to identify gait asymmetries. Participants walked across the mat three times with each bare foot to identify differences in the load profiles of the right and left feet, as well as to analyze the dynamics of body weight shift and local high-pressure points. Foot function was also be analyzed by stance phase region. The test is completely non-invasive.
  • The International Physical Activity Questionnaire (IPAQ), long version (IPAQ) - Polish version 53 was used to assess physical activity levels. Questions concern physical activity over the last 7 days, including activities performed at work, at home and around the home, while traveling, and during free time devoted to recreation, exercise, or sports.
  • questionnaires on health-related quality of life (SF-36) Health-related quality of life was assessed using the SF-36 questionnaire. This questionnaire consists of 36 questions that fall into eight categories related to mental and physical health: physical functioning, health problems limiting the performance of current social functions (physical role), somatic pain, general health, vitality, social functioning, emotional problems limiting the performance of current social functions (emotional role), and mental health.
  • geriatric depression scale (GDS) It consists of 30 questions, each answered with a yes or no. If the participant has difficulty understanding the questions, assistance with reading and completing the scale is acceptable. The scale score does not constitute a diagnosis of depression, but it can provide diagnostic guidance.
  • The Montreal Cognitive Assessment (MoCA) It is screening tool for detecting mild cognitive impairment (MCI) and early signs of dementia. It assesses multiple cognitive domains, including memory, language, attention, visuospatial skills, executive functions, and orientation, by requiring individuals to perform a series of tasks like drawing a clock face, recalling words, and solving simple math problems.

The study will determine gait patterns and any asymmetries. This information can be useful in selecting potential orthopedic equipment and appropriate corrective exercises.

The prevention of injuries related to falls caused by abnormal gait patterns will be discussed.

The study results will be used to implement therapeutic programs aimed at correcting identified functional abnormalities in older adults. After completing the project, the women participating in the study will receive an exercise program to correct their individual deficits.

02

Conditions studied

  • Physical Performance and Fitness in Old Age

Keywords

  • activity in geriatrics
  • postmenopausal mental fitness
  • body stability in old age
  • postmenopausal physical fitness
  • fullerton test
  • spirometry
03

In context

Lead sponsor

The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • female
  • minimum age 65 years
  • independence in performing everyday activities
  • ability to actively participate in sports activities twice a week
  • consent from the doctor to participate in sports activities

Exclusion criteria

Exclusion Criteria:

  • diseases of the locomotor system preventing independement movement
  • active or post cancerous disease
  • unstable ischemic heart disease
  • drug and alcohol addiction
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Coordination Group, the goal is to improve motor coordination and balance

    Eye-hand coordination exercises, balance exercises, walking and running exercises, exercises with scarves and balls, senomotor exercises

    Other: Coordination Training

  • Active comparator
    Mobility Group, the goal is to improve the range of motion in the joints

    Exercisec focused on the mobility of a single joint. The exercises performed in various positions and using small sports equipment. Yoga elements and breathing exercises were also included.

    Other: Mobility Training

  • Active comparator
    Core Stability Group, the goal is to improve postural stability

    Exercises focused on the postural stabilization, exercises for steady positioning while sitting, standing, or moving. The exercises in various positions and using small sports equipment for the balance and core strength

    Other: Core Training

  • No intervention
    Control Group not participating in any sports activity

    The group included 25 women over 65 years of age. The group participated in no sports activities

Interventions

  • OtherCoordination Training

    The group included 25 women over 65 years of age. The group participated in sports activities twice a week for three months. Each training session lasted 45 minutes and focused on the coordination and balance. The exercises were performed in various positions and using small sports equipment to achieve smooth, accurate, and controlled movements. These was achieved by exercises with: * Coordination ladders - developing rhythm, speed, and precision * Unstable surface exercises - improving balance and postural control * Reaction exercises (e.g., responding to auditory/visual signals). * Multitasking tasks - combining physical and mental elements * Exercises in variable conditions (e.g., closed eyes, non-standard equipment). * Movement games and activities - varying directions, speeds, and reactions to external stimuli, developing the ability to switch and adapt movement.

  • OtherCore Training

    The group included 25 women over 65 years of age. The group participated in sports activities twice a week for three months. Each training session lasted 45 minutes and focused on the postural stabilization to keep the body's center of mass within its, allowing for steady positioning while sitting, standing, or moving. The exercises were performed in various positions and using small sports equipment. exercises were chosen to improve the body's ability to control and maintain its position against gravity, enhancing balance and core strength

  • OtherMobility Training

    The group included 25 women over 65 years of age. The group participated in sports activities twice a week for three months. Each training session lasted 45 minutes and focused on the mobility of a single joint. The exercises were performed in various positions and using small sports equipment. Yoga elements and breathing exercises were also included.

06

What researchers measure

Primary outcomes

  1. Level of Physical Fitness

    physical fitness measured using the Fullerton test

    Time frame: From enrollment to the end of treatment/training at 14 weeks

  2. Quality of Life Assessment

    SF-36 Questionnaire * The recoded values for items within a domain are summed and then transformed to a 0-100 scale (0 = worst, 100 = best health). * Eight Scales (Domains): Physical Functioning (PF) Role Limitations due to Physical Health (RP) Role Limitations due to Emotional Problems (RE) Vitality (VT) Emotional Well-being (MH) Social Functioning (SF) Bodily Pain (BP) General Health (GH)

    Time frame: From enrollment to the end of treatment/training at 14 weeks

  3. Assessment of Lung Function

    Vital Capacity in liters (L)

    Time frame: From enrollment to the end of treatment/traing at 14 weeks

  4. Assessment of Lung Function

    Tidal Volume in millliliters (mL)

    Time frame: From enrollment to the end of treatment/traing at 14 weeks

  5. Assessment of Lung Function

    Respiratory Rate (RR) in breath per minute (bpm)

    Time frame: From enrollment to the end of treatment/traing at 14 weeks

  6. Assessment of Lung Function

    Tiffeneau-Pinelli Index - FEV1/FVC Ratio (%)

    Time frame: From enrollment to the end of treatment/traing at 14 weeks

  7. Assessment of Lung Function

    Maximal Mid-Expiratory Flow Rate (MMEF or FEF 25-75) in L/s

    Time frame: From enrollment to the end of treatment/traing at 14 weeks

  8. Level of Physical Fitness

    IPAQ international physical activity questionnaire (MET-minutes/week units) Measured various domains of the eve-ry-day life: at work, while traveling, doing housework or leisure activities and sports. It mea-sures the time spent sitting at weekdays and weekends. It allows easy classification of the respondents physical activity into three categories: low (below 600 MET-minutes/ week), moderate (600-1500 lub 600-3000 MET-minutes/week) and high (above 1500 or 3000 MET-minutes/week).

    Time frame: From enrollment to the end of tratment/training at 14 weeks

  9. Quality of Life Assesment

    The Geriatric Depression Scale (GDS) * scoring involves answering yes/no questions, with points given for specific answers * For the common 30-item scale, scores usually mean: 0-9 Normal, 10-19 Mild Depression, 20-30 Severe Depression

    Time frame: From enrollment to the end of treatment/training at 14 weeks

Secondary outcomes

  1. Anthropometric Measurements using TANITA MC-980 MA device (TANITA, Japan).

    The examination was be performed using a TANITA MC-980 MA device (TANITA, Japan), using Bioelectrical Impedance Analysis (BIA) \- total body water (TBW), extracellular water (ECW), intracellular water (ICW)

    Time frame: From enrollment to the end of treatment/training at 14 weeks

  2. Assessment of Cognitive Function

    Montreal Cognitive Assessment (MoCa) assesses: Memory, Attention and concentration, Language, Visuospatial skills, Executive functions, Conceptual thinking and Orientation \- scoring up to 30 points, with higher scores indicating better function (normal is \~26+)

    Time frame: From enrollment to the end of treatment/training at 14 weeks

  3. FootMat Clinical 7.10 Measurement of Foot Load and its Behavior while Walking by pressure sensor mat, MobileMat, provide by Tekscan

    Metatarsal or Heel Maximum Force in Newton (N) 1st and 2nd Peak of Foot (left and right) in seconds Measurement of the maximum force and average pressure on the plantar side of the foot while walking (dynamic test)

    Time frame: From enrollment to the end of treatment/training at 14 weeks

  4. Antropometric Measurements using TANITA MC-980 MA device (TANITA, Japan)

    The examination was be performed using a TANITA MC-980 MA device (TANITA, Japan), using Bioelectrical Impedance Analysis (BIA) \- weight in kiligrams

    Time frame: from enrollment to the end of treatment/training at 14 weeks

  5. Anthropometric Measurements using TANITA MC-980 MA device (Tanita, Japan)

    The examination was be performed using a TANITA MC-980 MA device (TANITA, Japan), using Bioelectrical Impedance Analysis (BIA) \- BMI - weight and height will be combined to report BMI in kg/m\^2

    Time frame: from enrollment to the end of treatment/training at 14 weeks

  6. Anthropometric Measurements using TANITA MC-980 MA device (Tanita, Japan)

    \- skeletal muscle mass in kilograms

    Time frame: from enrollment to the end of the treatment/training at 14 weeks

  7. Anthropometric Measurements using TANITA MC-980 MA device (Tanita, Japan)

    * body fat mass in kilograms * body fat percentage (%)

    Time frame: from enrollment to the end of treatment/training at 14 weeks

  8. Anthropometric Measurements using TANITA MC-980 MA device (Tanita, Japan)

    \- fat free mass index based on weight, height and body fat percentage

    Time frame: from enrollment to the end of treatment/training at 14 weeks

  9. Anthropometric Measurements using TANITA MC-980 MA device (Tanita, Japan)

    \- visceral fat level 1-12: Healthy level of visceral fat. 13-59: Excessive level of visceral fat.

    Time frame: from enrollment to the end of treatment/training at 14 weeks

  10. Anthropometric Measurements using Goniometer Saehen provide by StanleyMed

    Saehan Goniometr: \- range of motion in the hip, knee and ankle joints (Adduction, Abduction, Flexion, Extension, External- and Internalrotation)

    Time frame: from enrollment to the end of treatment/training at 14 weeks

  11. Anthropometric Measurement with SECA 201 anthropometric tape (SECA, Germany)

    \- hip and waist circumferences

    Time frame: from enrollment to the end of treatment/training at 14 weeks

  12. Anthropometric Measurements with SECA 201 anthropometric tape (SECA, Germany)

    \- chest mobility

    Time frame: from enrollment to the end of treatment/training at 14 weeks

  13. Anthropometric Measurement with SECA 201 anthropometric tape (SECA, Germany)

    \- length and circumference of the lower limbs

    Time frame: from enrollment to the end of treatment/training at 14 weeks

07

Study locations

1 site
  • The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
    Kalisz, Wielkopolska 62-800, Poland
08

References and documents

Individual participant data

Plan to share: Yes — in planning

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 1 year after publication with no end date

Access criteria: still on planning, beginning after the publication

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2024 to primary completion in Apr 2025, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2025
First posted
Dec 26, 2025
StartActual
Oct 1, 2024
Primary completionActual
Apr 11, 2025
CompletionActual
Apr 30, 2025
Last update
Dec 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07304622
Lead sponsor
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Responsible party
Sponsor
First posted
Dec 26, 2025
Start date
Oct 1, 2024
Primary completion
Apr 11, 2025
Completion
Apr 30, 2025
Last update
Dec 26, 2025

Study contacts

Katarzyna Domaszewska, Prof.dr hab.
study chair · University School of Physical Education in Poznan
Marta L Hofman, Master
principal investigator · The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Piotr Szewczyk, Dr
study director · The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Katarzyna Sobczak, Dr
principal investigator · University School of Physical Education in Poznan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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