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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).
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:
Before the first and after the last exercise class, the following tests was performed:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coordination Group, the goal is to improve motor coordination and balance | Active Comparator | Eye-hand coordination exercises, balance exercises, walking and running exercises, exercises with scarves and balls, senomotor exercises |
|
| Mobility Group, the goal is to improve the range of motion in the joints | Active Comparator | 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. |
|
| Core Stability Group, the goal is to improve postural stability | Active Comparator | 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 |
|
| Control Group not participating in any sports activity | No Intervention | The group included 25 women over 65 years of age. The group participated in no sports activities |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coordination Training | Other | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of Physical Fitness | physical fitness measured using the Fullerton test | From enrollment to the end of treatment/training at 14 weeks |
| Quality of Life Assessment | SF-36 Questionnaire
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) | From enrollment to the end of treatment/training at 14 weeks |
| Assessment of Lung Function | Vital Capacity in liters (L) | From enrollment to the end of treatment/traing at 14 weeks |
| Assessment of Lung Function | Tidal Volume in millliliters (mL) | From enrollment to the end of treatment/traing at 14 weeks |
| Assessment of Lung Function | Respiratory Rate (RR) in breath per minute (bpm) | From enrollment to the end of treatment/traing at 14 weeks |
| Assessment of Lung Function | Tiffeneau-Pinelli Index - FEV1/FVC Ratio (%) | From enrollment to the end of treatment/traing at 14 weeks |
| Assessment of Lung Function | Maximal Mid-Expiratory Flow Rate (MMEF or FEF 25-75) in L/s |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From enrollment to the end of treatment/training at 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katarzyna Domaszewska, Prof.dr hab. | University School of Physical Education in Poznan | Study Chair |
| Marta L Hofman, Master | The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz | Principal Investigator |
| Piotr Szewczyk, Dr | The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz | Study Director |
| Katarzyna Sobczak, Dr | University School of Physical Education in Poznan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz | Kalisz | Wielkopolska | 62-800 | Poland |
in planning
Beginning 1 year after publication with no end date
still on planning, beginning after the publication
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|
| Core Training | Other | 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 Training | Other | 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. |
|
| From enrollment to the end of treatment/traing at 14 weeks |
| 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). | From enrollment to the end of tratment/training at 14 weeks |
| Quality of Life Assesment | The Geriatric Depression Scale (GDS)
| From enrollment to the end of treatment/training at 14 weeks |
| 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+) | From enrollment to the end of treatment/training at 14 weeks |
| 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) | From enrollment to the end of treatment/training at 14 weeks |
| 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 | from enrollment to the end of treatment/training at 14 weeks |
| 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 | from enrollment to the end of treatment/training at 14 weeks |
| Anthropometric Measurements using TANITA MC-980 MA device (Tanita, Japan) | - skeletal muscle mass in kilograms | from enrollment to the end of the treatment/training at 14 weeks |
| Anthropometric Measurements using TANITA MC-980 MA device (Tanita, Japan) |
| from enrollment to the end of treatment/training at 14 weeks |
| Anthropometric Measurements using TANITA MC-980 MA device (Tanita, Japan) | - fat free mass index based on weight, height and body fat percentage | from enrollment to the end of treatment/training at 14 weeks |
| 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. | from enrollment to the end of treatment/training at 14 weeks |
| 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) | from enrollment to the end of treatment/training at 14 weeks |
| Anthropometric Measurement with SECA 201 anthropometric tape (SECA, Germany) | - hip and waist circumferences | from enrollment to the end of treatment/training at 14 weeks |
| Anthropometric Measurements with SECA 201 anthropometric tape (SECA, Germany) | - chest mobility | from enrollment to the end of treatment/training at 14 weeks |
| Anthropometric Measurement with SECA 201 anthropometric tape (SECA, Germany) | - length and circumference of the lower limbs | from enrollment to the end of treatment/training at 14 weeks |