Safety of an Unsupervised Physical Activity Program and Effects Over Blood Pressure, Physical Fitness and Quality of Life of Elderly Hypertensive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Lower Blood Pressure and or keeping it under control
研究概览
简要总结
To evaluate safety and the effects of a unsupervised physical activity program (USPAP) over blood pressure (BP), physical fitness (PF) and quality of life (QL) of elderly hypertensive patients.
详细描述
The present study was approved by the Human and Animal Ethics Committee of the institution and the participants were only randomized to participate after having signed the informed consent form.
A population of elderly hypertensive patients registered at a reference center for hypertension treatment was selected. The sample size was calculated considering a test power of 80% with significance level of 5% and estimating a difference to be observed within the BP values of 7 mmHg for systolic blood pressure (SBP) and 4 mmHg for diastolic blood pressure (DBP). The sample calculated was 25 participants in each group being selected 20% more in case of losses.
An electronic chart was created with numbers for the patients that were randomized into control (CG) and intervention groups (IG).
The IG was included in an USPAP and the control group was kept under the usual care of the service that includes orientation to perform PA according to the World Health Organization recommendations.
Before the beginning of the protocol clinical and laboratorial data collected included: weight, height, waist circumference, fasting glucose, hemoglobin A1C and lipid profile.
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
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria were:
- •60 years old or more, stable BP on the last three months, no changes on pharmacological treatment over the last six months and a sedentary behavior (non-participation in any kind of physical activity for at least 2 months).
排除标准
- •considered were:
- •uncontrolled diabetes
- •congestive heart failure
- •acute myocardial infarction in the last six months
- •stroke in the last six months or under rehabilitation
- •previously diagnosed chronic renal failure
- •acute infectious diseases
- •recent systemic or pulmonary embolism
- •pulmonary hypertension
- •BP higher than 159 x 99 mmHg
- •neuromuscular
- •musculoskeletal or articular disorders diagnosed and not treated
- •clinical evaluation restraining PA
- •any situation preventing the patient from walk. Those criteria were verified in patients' medical charts.
研究组 & 干预措施
Unsupervised exercise program
To verify the interference of an unsupervised exercise program on blood pressure, physical fitness, quality of life and safety in elderly hypertensive patients. Participants were divided into the study group or control group
干预措施: Unsupervised exercise program (Behavioral)
Physical fitness and quality of life
To verify the interference of a walking program on physical fitness and quality of life.
干预措施: Physical fitness and quality of life (Behavioral)
结局指标
主要结局
Lower Blood Pressure and or keeping it under control
时间窗: 12 weeks
次要结局
- Improve Cardiorespiratory fitness.(12 weeks)
- Improve abdominal strength.(12 weeks)
- Quality of life(12 weeks)
研究者
Patricia Silva Carneiro
Principal Investigator
Universidade Federal de Goias