The Effect of 10 Weeks of Physical Exercise on Glycated Hemoglobin and Blood Pressure in Elderly People With Multimorbidity Conditions: a Controlled and Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Glycated hemoglobin (Hb1Ac)
研究概览
简要总结
The main objective of the study is to compare the effect of two different types of physical exercise modalities on glycated hemoglobin and blood pressure in elderly individuals with multimorbidity. The main characteristic of the proposal is that it is experimental, with two intervention groups with physical exercise that will be randomized in the order of participation of the groups and forwarded to the researchers regarding the evaluations and training periods. In addition, the study will be controlled, as it has a control group that will not perform any intervention with physical exercises during the study period. To allocate the participants in each exercise group and for the control group, the researchers will use the 1:1 method, the user will receive an automatic generator through the random.org website.
The main questions raised by the studies will be: Is land-based training more effective than aquatic training for this population in improving the primary outcomes? Is there a difference between training at these intensities and not doing any physical exercise in this population with these primary outcomes?
Participants in the 2 intervention groups will:
Train 3x per week for 10 weeks at intensities that will progress over the weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being elderly adult 60 years old
- •Having grade 1 medicated hypertension (systolic blood pressure ≥ 140 and diastolic blood pressure ≥ 90) or having type 2 diabetes mellitus
- •Volunteers may have other morbidities such as: anxiety/depression, knee osteoarthritis or obesity
- •Be fit for the practice of physical activity
排除标准
- •Being a smoker
- •Have severe musculoskeletal problems that prevent you from carrying out physical activities
- •Unable to carry out the protocol completely
研究组 & 干预措施
Combined physical exercise in land
Combined physical exercise performed in gym 3 times per week
干预措施: Exercise (Other)
Combined physical exercise in water
Combined physical exercise performed in water 3 times per week.
干预措施: Exercise (Other)
Control Group
The control group will not performed physical exercise for ten weeks.
干预措施: Control (Other)
结局指标
主要结局
Glycated hemoglobin (Hb1Ac)
时间窗: 10 weeks
In the pre- and post-training moments during the morning and fasting period, venous blood samples will be collected to analyze the glycemic profile. The outcome measure will be expressed as a percentage (%), representing the average blood glucose level over the last 2 to 3 months.
Blood pressure
时间窗: 10 weeks
Office blood pressure (OBP) will be evaluated and monitored during pre-training moments using automatic monitors, and Home Blood Pressure Monitoring (HBPM) will be conducted with appropriate collection devices according to the 2021 European Society of Hypertension practice guidelines for office and out-of-office blood pressure measurement.The results of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) will be shown in millimeters of mercury (mmHg) for OBP and HBPM.
次要结局
- Heart rate variability(10 weeks)
- Lipid Profile (LDL, HDL, VLDL and Triglycerides)(10 weeks)
- Body Mass Index (BMI)(10 weeks)
- Fasting glucose(10 weeks)
- World Health Organization Quality of Life - WHOQOL questionnaire(10 weeks)
- Agility(10 weeks)
- Cardiorespiratory fitness(10 weeks)
- Hand grip strength(10 weeks)
- Sit and stand test(10 weeks)
- Internation Physical Activity - IPAQ questionnaire(10 weeks)
- Pittsburgh Sleep Quality Index - PSQIquestionnaire(10 weeks)
- Depression, Anxiety, and Stress Scale - DASS 21(10 weeks)
- Balance test(10 weeks)
- Muscle electrical activity(10 weeks)