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Physical Performance and Fitness in Old AgeNCT07304622

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

A study testing Coordination Training, Core Training and Mobility Training in people with Physical Performance and Fitness in Old Age, run by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older, women onlyHealthy volunteers can take part
What is being tested?
Coordination Training, Core Training and Mobility Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 sitePoland
Study dates
1 Oct 2024to 30 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

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 65 years and older
  • Women only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

    Kalisz, Wielkopolska, 62-800

Other trials in Poland

About this study

Official title: Comprehensive Assessment of the Impact of Various Therapeutic Methods on Gait Quality, Physical and Mental Fitness of Postmenopausal Women.

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?

Read more

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.

Being tested
Coordination Training, Core Training, Mobility Training
Keywords
activity in geriatrics, postmenopausal mental fitness, body stability in old age, postmenopausal physical fitness, fullerton test, spirometry

What participants receive

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

  • Coordination TrainingOther

    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.
  • Core TrainingOther

    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

  • Mobility TrainingOther

    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.

Study groups in NCT07304622
Study groupRoleWhat they receive
Coordination Group, the goal is to improve motor coordination and balanceActive comparatorEye-hand coordination exercises, balance exercises, walking and running exercises, exercises with scarves and balls, senomotor exercises
Receives: Other: Coordination Training
Mobility Group, the goal is to improve the range of motion in the jointsActive comparatorExercisec 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.
Receives: Other: Mobility Training
Core Stability Group, the goal is to improve postural stabilityActive comparatorExercises 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
Receives: Other: Core Training
Control Group not participating in any sports activityNo interventionThe group included 25 women over 65 years of age. The group participated in no sports activities

What is being measured

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

  1. Level of Physical Fitness

    physical fitness measured using the Fullerton test

    Measured: 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)

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

  3. Assessment of Lung Function

    Vital Capacity in liters (L)

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

  4. Assessment of Lung Function

    Tidal Volume in millliliters (mL)

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

  5. Assessment of Lung Function

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

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

  6. Assessment of Lung Function

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

    Measured: 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

    Measured: 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).

    Measured: 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

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

Secondary outcomes (13)
  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)

    Measured: 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+)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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 (%)

    Measured: 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

    Measured: 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.

    Measured: 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)

    Measured: 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

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

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

    • chest mobility

    Measured: 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

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

Timeline

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

  1. First posted26 Dec 2025
  2. Study start1 Oct 2024
  3. Primary completion11 Apr 2025
  4. Study completion30 Apr 2025

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07304622
Sponsor's protocol ID
Kalisz 2025-09
Status last verified
Dec 2025
First submitted
1 Dec 2025
Last updated
26 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: in planning

Questions about this trial

What is this clinical trial studying?

A study testing Coordination Training, Core Training and Mobility Training in people with Physical Performance and Fitness in Old Age, run by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 26 Dec 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Level of Physical Fitness (time frame: From enrollment to the end of treatment/training at 14 weeks). The study lists 9 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 26 Dec 2025.

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