Comprehensive Assessment of the Impact of Various Therapeutic Methods on Gait Quality, Physical and Mental Fitness of Postmenopausal Women.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Level of Physical Fitness
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •diseases of the locomotor system preventing independement movement
- •active or post cancerous disease
- •unstable ischemic heart disease
- •drug and alcohol addiction
结局指标
主要结局
Level of Physical Fitness
时间窗: From enrollment to the end of treatment/training at 14 weeks
physical fitness measured using the Fullerton test
Level of Physical Fitness
时间窗: From enrollment to the end of tratment/training at 14 weeks
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).
Quality of Life Assessment
时间窗: From enrollment to the end of treatment/training at 14 weeks
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)
Assessment of Lung Function
时间窗: From enrollment to the end of treatment/traing at 14 weeks
Vital Capacity in liters (L)
Quality of Life Assesment
时间窗: From enrollment to the end of treatment/training at 14 weeks
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
次要结局
- Anthropometric Measurements using TANITA MC-980 MA device (Tanita, Japan)(from enrollment to the end of the treatment/training at 14 weeks)
- Anthropometric Measurements with SECA 201 anthropometric tape (SECA, Germany)(from enrollment to the end of treatment/training at 14 weeks)
- Anthropometric Measurements using Goniometer Saehen provide by StanleyMed(from enrollment to the end of treatment/training at 14 weeks)
- Antropometric 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)(from enrollment to the end of 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)
- Assessment of Cognitive Function(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(From enrollment to the end of treatment/training at 14 weeks)
- Anthropometric Measurement with SECA 201 anthropometric tape (SECA, Germany)(from enrollment to the end of treatment/training at 14 weeks)