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

The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Status: Completed

Conditions: Physical Performance and Fitness in Old Age

Treatments: Other: Coordination Training; Other: Core Training; Other: Mobility Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07304622

Kalisz 2025-09

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

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

Active Comparator group

Description:

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

Treatment:

Other: Coordination Training

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

Active Comparator group

Description:

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.

Treatment:

Other: Mobility Training

Core Stability Group, the goal is to improve postural stability

Active Comparator group

Description:

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

Treatment:

Other: Core Training

Control Group not participating in any sports activity

No Intervention group

Description:

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