The Effect of Physical Activity Performed Under the Guidance of Nurse to the Individuals With Moderate Risk of Cardiovascular Disease on Decreasing Risk Level: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Change in CVD risk level
研究概览
简要总结
Objective: The aim of the first part of this study with two stages is to determine prevalence of CVD risk and the associated variables in individuals aged 40-65 years registered in a Family Health Center (FHC) in city center of Antalya; the aim of the second one is to evaluate the effect of intervention to increase physical activity in individuals with moderate risk of CVD on decreasing the risk level.
Methods: Stage 1 and Stage 2 were conducted as cross-sectional and Randomized Controlled Experimental Trial, respectively.
In the first stage the CVD risk level was calculated using the HeartScore. In the second stage, 11 individuals with moderate CVD risk (2-<5%) found in the intervention group participated into a 12-week physical activity program (a moderate walk outdoor, with group 5 days in a week, each lasting for 40 minutes) guided by nurse. CVD brochure and physical activity guide was distributed to 11 individuals in control group within the scope of routine practice of FHCs.
详细描述
The purpose of this study is to determine Cardiovascular Disease (CVD) risk level in 40-65 year-old individuals coming to a FHC and to evaluate the effect of increasing the physical activity and interventions about the changeable risk factors on reducing the risk level in individuals with moderate CVD risk.
Hypothesis; the 12-week group walking activity about changing CVD risk factors reduces the risk level more in intervention group compared to the control group (H1).
It provides blood pressure control in the intervention group. It reduces cholesterol. It helps reducing the weight, BMI, and waist circumference values. This study was conducted in two stages. Stage 1: In order to determine the high risk prevalence of CVD, it was carried out in Akdeniz FHC located in Konyaalti Central District of Antalya between April and September 2016.
Stage 2: In order to evaluate the effect of the interventions for the changeable risk factors (HeartScore 2-<5%) in individuals with moderate level of CVD risk, the study was conducted as a Randomized Controlled Experimental Trial between October-December 2016 in April 23 Park located near to FHC in the same region. There is a hiking trail around this park. This trail is 860-meter long, covered with rubber, and suitable for walking. In addition, there are two fields for exercise on apparatus in the east and west side of the park.
Stage 1 Population and Sample The population of the study consisted of 2390 individuals aged between 40 and 65 years registered in the Akdeniz FHC. In the study, the sample size was calculated by considering the CVD moderate risk prevalence (27.4%) obtained by Ünal et al. in their study conducted with individuals living in Balcova region via the formula used in the cases of known population and the minimum sample size for this study was determined as 27012. However, 327 individuals were voluntary to participate in the study between the dates when the study was conducted and their risk levels were calculated by using HeartScore® program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being aged between 40 and 65 years,
- •Not having a problem that could prevent walking activity,
- •Being voluntary to participate in the study.
排除标准
- •Having a known and diagnosed CVD, being diagnosed with diabetes (they are evaluated to have a high risk in the European Guidelines on Cardiovascular Disease Prevention and treatment is recommended),
- •Having walking disabled,
- •Not being voluntary to participate in the study.
结局指标
主要结局
Change in CVD risk level
时间窗: 12 week
"HeartScore® program" was used to determine the CVD risk level in the first stage of the study. In the second part, the risk level was evaluated using HeartScore program for the second time. HeartScore® is a primary prevention tool that provides risk measurement for people who have not had any cardiovascular disease. According to the SCORE score calculated in the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice, individuals are divided into 4 risk categories. Accordingly, if SCORE score is; * ≥%10, very high risk category, * Between ≥%5- \<%10, high risk category * Between ≥%2- \<5, moderate risk category, * \<%1, then they are in the low risk category.
次要结局
- Change in Opinions and Experiences about Physical Activity(12 week)
- Change in Physical activity level(12 week)