Effect of Aerobic Training on Hemodynamic, Metabolic and Climacteric Symptoms in Postmenopausal Women With Multimorbidity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in glucose
研究概览
简要总结
People affected by multiple chronic diseases have a greater chance of hospitalization, longer hospital stays, worse general health, worse physical and mental function and lower functional capacity, with an average risk of 50% of functional decline with each additional condition. The frequency of multimorbidity is higher in older, inactive women, who live in urban areas in low- and middle-income countries, the most affected by multimorbidity. The practice of physical exercise is an important component in the prevention of multiple chronic diseases, in which lower levels of physical activity were associated with an increased prevalence of multimorbidity in women aged 16 to 24 years. And regardless of the presence of multimorbidity, engaging in a healthier lifestyle, including regular physical activity, was associated with up to 7.6 more years of life for women, improving the individual's general health status even when multimorbid.
The hypothesis is that multimorbid women have a worse general health status when compared to women without multimorbidity, but aerobic exercise will be able to improve health parameters in 12 weeks of training.
This is a quasi-experimental clinical trial with a 12-week aerobic training intervention in postmenopausal women with and without cardiometabolic multimorbidity. Participants were allocated into groups according to the amount of cardiometabolic diseases, with the Morbidity group (MORB) being composed of women with one or no chronic cardiometabolic disease and the Multimorbidity group (MULTI) with two or more chronic cardiometabolic diseases.
The assessments of arterial stiffness, 24-hour ambulatory pressure, blood pressure variability, heart rate variability, lipid and glucose profile, body composition and climacteric symptoms were performed before and after the training period.
The study was carried out at the Laboratory of Cardiorespiratory and Metabolic Physiology at the Faculty of Physical Education of the Federal University of Uberlândia, Uberlândia, Brazil and approved by the Ethics Committee for studies in humans (CAEE: 12453719.1.0000.5152). All participants signed a consent form. The experiments followed the principles of the Declaration of Helsinki.
The program consists of aerobic physical exercises performed three times a week on non-consecutive days for 12 weeks with an intensity of 65% to 75% of the reserve heart rate.
详细描述
The sample size was classified using the G * Power 3.1 software (University of Dusseldorf, Dusseldorf, Germany), adopting an α error of 5%, 80% power analysis, 0.5 correlation between repeated measures and a correction of non-sphericity of 1, in an F-family of intra-between analysis. Changes in serum triglycerides were evaluated as the primary study endpoint. The investigators did not not found the in literature the study with design and calculation prediction according to the calculation of this study with the effect size of f = 0.24 for the sample calculation. Thus, was found a minimum required sample of 38 subjects (19 per group).
Results were found as mean ± standard error. Unpaired testing was used to compare baseline characteristics between groups. Comparison between groups and duration of arterial stiffness, lipid profile, glucose profile, climacteric symptoms, body composition and ABPM were made by Generalized Equation Estimates (GEE) of two factors (time, group and their interaction) with Bonferroni correction. The analyzes were performed by intention-to-treat (including those who did not complete the study: MORB n = 18; MULTI = 24) using the last-observation carried forward method. A p value <0.05 was used for statistical significance and all statistical analyzes were performed with Statistical Package for the Social Sciences (SPSS) software v26.0 (IBM, New York, USA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The Care Providers followed the standard of care for all participants during the training sessions, with a standardized approach such as: measuring the blood pressure of all participants before starting the training session, intensity control during training was done by zone of individualized heart rate, regardless of the group, presented in a spreadsheet without information about the group to which the patient was assigned. The outcomes assessor were not aware of the formation of groups and access only to the participants' codes, were objective and with generation of saved files for later conference by the Investigator.
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women (amenorrhea of at least 12 months; Estradiol <32.2 pg / mL),
- •Aged between 50 and 70 years,
- •Able to do aerobic exercise on track, do not have physical problems or cardiovascular complications that prevent them from exercising.
- •Non-smokers ,
- •Who do not use Hormone Therapy or have not finished the treatment for more than 1 year,
- •As diagnostic criteria for cardiometabolic diseases: Obesity (BMI> 29.9 kg / m2; Use of antihypertensive drugs and/or hypertension (systolic blood pressure at rest > 139 mmHg and diastolic blood pressure > 89 mmHg; dyslipidemia (LDL ≥160mg / dL and / or triglycerides ≥150mg / dL and / or total cholesterol ≥190mg / dL and / or HDL ≤50mg / dL. In the case of diabetics (blood glucose > 126 mg / dL and / or HbA1c ≥ 6.5% and diagnosed with type 2 diabetes mellitus: for at least one year, being using a hypoglycemic and clinically stable for up to minimum 6 months, with glycemic control by medication or exogenous insulin and without chronic complications such as diabetic foot, nephropathy, retinopathy or neuropathies.
排除标准
- •Present some inability to carry out the prescribed training volume or intensity,
- •Not obtain medical clearance after maximum exercise test
- •Start practicing another physical exercise protocol concurrently with this project.
研究组 & 干预措施
Multimorbidity Group (MULTI)
Multimorbidity group is composed of post menopausal women with two or more chronic diseases cardiometabolic (Hypertension, diabetes, dislipidemias, obesity).
干预措施: Aerobic training (Behavioral)
Morbidity Group (MORB)
Morbidity group is composed of postmenopausal women with one or no chronic cardiometabolic disease (Hypertension, diabetes, dislipidemias, obesity)
干预措施: Aerobic training (Behavioral)
结局指标
主要结局
Change in glucose
时间窗: Before and after 12 weeks of intervention.
The blood samples were collected after an overnight fast, five days before, and 72 h after, the last exercise training session to eliminate the acute effects of the exercise. Plasma concentrations of glucose (mg/dL) were determined by enzymatic colorimetric methods. The analyze was performed using an automated system using commercial kit.
Change in Lipid profile in 12 weeks
时间窗: Before and after 12 weeks of intervention.
The blood samples were collected after an overnight fast, five days before, and 72 h after, the last exercise training session to eliminate the acute effects of the exercise. Plasma concentrations of total cholesterol (mg/dL), triglycerides (mg/dL), high density lipoprotein (HDL) (mg/dL) and low density lipoprotein (LDL) cholesterol (mg/dL) were determined by enzymatic colorimetric methods. All analyzes were performed using an automated system using commercial kits.
Change in 24-hour ambulatory blood pressure in 12 weeks
时间窗: Before and after 12 weeks of intervention.
Blood pressure (Systolic, diastolic, mean) (mmHg) was assessed before and after 12 weeks of training through ambulatory monitoring (ABPM) using the Dyna Mapa+ device (São Paulo, Brazil). The monitor was programmed with measurements every 30 minutes for 24 hours, standardizing the start of monitoring in the morning between 7 am and 8 am. Along with the monitor, the participants filled out a daily record of activities (sleep, food and work) or events that could interfere with blood pressure or measurements, with sleep and wakefulness periods being individually determined according to the time reported in each diary. Measurements obtained 24 hours of monitoring and with at least 70% of measurements valid in this period were considered valid.
Change in glycated hemoglobin (HbA1c)
时间窗: Before and after 12 weeks of intervention.
The blood samples were collected after an overnight fast, five days before, and 72 h after, the last exercise training session to eliminate the acute effects of the exercise. The concentration (%) of glycated hemoglobin (HbA1c) was determined by the turbidimetry method. All analyzes were performed using an automated system, using commercial kits.
Change in Arterial stiffness in 12 weeks
时间窗: Before and after 12 weeks of intervention
Arterial stiffness was assessed by measuring the Pulse Wave Velocity (PWV) through the applanation tonometry method, performed on 3 measurements and the average of the three was performed to obtain the final value. It is a non-invasive, painless method with instantaneous results and considered the gold standard for determining arterial stiffness. This method is based on the principles of ocular tonometry used to measure intraocular pressure by "flattening" the surface of the eyeball.
次要结局
- Blood Pressure Variability(Before and after 12 weeks of intervention)
- Heart rate variability(Before and after 12 weeks of intervention)
- Change in Body composition in 12 weeks(Before and after 12 weeks of intervention.)
- Assessment of anthropometry(Before and after 12 weeks of intervention)
- Assessment of climacteric symptoms - Cervantes Quality of Life Scale(Before and after 12 weeks of intervention.)
- Assessment of climacteric symptoms - Menopause Rating Scale (MRS)(Before and after 12 weeks of intervention.)
研究者
Juliene Gonçalves Costa
Principal Investigator Juliene Gonçalves Costa Dechichi
Federal University of Uberlandia