Effects of Life Style Intervention Manual on Metabolic, Cardiovascular, Respiratory and Physical Parameters in Pre Hypertensive Sedentary Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Change in Serum Total Cholesterol
研究概览
简要总结
Hypertension is an increasingly important medical and public health issue. The prevalence of hypertension increases with advancing age to the point where more than half of people 60-69 years of age and approximately three-fourths of those 70 years of age and older are affected. The age related rise in SBP is primarily responsible for an increase in both incidence and prevalence of hypertension with increasing age. At present, it is estimated that about 1 billion people worldwide have hypertension (>140/90 mmHg), and this number is expected to increase to 1.56 billion by 2025.
Because of the new data on lifetime risk of hypertension and the impressive increase in the risk of cardiovascular complications associated with levels of BP previously considered to be normal, the JNC 7 report has introduced a new classification that includes the term "prehypertension" for those with BPs ranging from 120-139 mmHg systolic and/or 80-89 mmHg diastolic. This new designation is intended to identify those individuals in whom early intervention by adoption of healthy lifestyles could reduce BP, decrease the rate of progression of BP to hypertensive levels with age, or prevent hypertension entirely. Prehypertension is not a disease category. Rather, it is a designation chosen to identify individuals at high risk of developing hypertension, so that both patients and clinicians are alerted to this risk and encouraged to intervene and prevent or delay the disease from developing. Individuals who are pre hypertensive are not candidates for drug therapy based on their level of BP and should be firmly and unambiguously advised to practice lifestyle modification in order to reduce their risk of developing hypertension in the future.
The goal for individuals with prehypertension and no compelling indications is to lower BP to normal levels with lifestyle changes, and prevent the progressive rise in BP using the recommended lifestyle modifications.
详细描述
Adoption of healthy lifestyles by all persons is critical for the prevention of high BP and is an indispensable part of the management of those with hypertension. Weight loss of as little as 10 lbs (4.5 kg) reduces BP and/or prevents hypertension in a large proportion of overweight persons, although the ideal is to maintain normal body weight. BP is also benefited by adoption of the Dietary approaches to Stop Hypertension (DASH) eating plan which is a diet rich in fruits, vegetables, and low fat dairy products with a reduced content of dietary cholesterol as well as saturated and total fat (modification of whole diet). It is rich in potassium and calcium content. Dietary sodium should be reduced to no more than 100 mmol per day (2.4 g of sodium). Everyone who is able should engage in regular aerobic physical activity such as brisk walking at least 30 minutes per day most days of the week. Lifestyle modifications reduce BP, prevent or delay the incidence of hypertension, enhance antihypertensive drug efficacy and decrease cardiovascular risk. For example, in some individuals, a 1,600 mg sodium DASH eating plan has BP effects similar to single drug therapy. Combinations of two (or more) lifestyle modifications can achieve even better results. For overall cardiovascular risk reduction, patients should be strongly counseled to quit smoking.
Lifestyle modification involves altering long-term habits, typically of eating or physical activity, and maintaining the new behavior for months or years. Lifestyle changes are a more natural way toward therapeutic goals and should be an integral component of halting or even reversing early vascular aging as in pre hypertensive subjects. From a public health perspective, even a small reduction in BP should have a tremendous, beneficial effect on the occurrence of hypertension and its complications. In view of the current epidemic of BP-related diseases and the proven effects of lifestyle modifications on BP, the current challenge to health care providers, researchers, and public officials is to develop and implement effective life style intervention program comprising exercise dietary and educative component in clinical and public health strategies that achieve and maintain healthy lifestyle modification
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 25 - 40 years
- •Either gender
- •Clinic BP will be consistent with the diagnosis of pre-hypertension
- •Sedentary Subjects (<150 min/week or <600 MET-min/week on IPAQ Urdu Version)
排除标准
- •Body Mass Index less than 18.5 kg/m2 or greater than 45 kg/m2
- •Evidence of target organ damage such as left ventricular hypertrophy, angina, heart failure, stroke, chronic kidney disease, peripheral artery disease
- •Women of child-bearing age who tested positive for HCG & breastfeeding women
- •Individuals who could not read the consent or Participated in another study within 3 months
结局指标
主要结局
Change in Serum Total Cholesterol
时间窗: 16 Weeks
Serum Total Cholesterol measured at baseline, 8th Week post treatment and 16th Week post treatment from intravenous blood specimen.
Change in Forced Expiratory Volume - 01 Second (FEV1)
时间窗: 16 Weeks
Forced Expiratory Volume - 01 Second (FEV1) measured at baseline, 8th Week post treatment and 16th Week post treatment using digital spirometer.
Change in Forced Expiratory Volume 1 Second / Forced Vital Capacity (FEV1/FVC)
时间窗: 16 Weeks
Forced Expiratory Volume 1 Second / Forced Vital Capacity (FEV1/FVC) measured at baseline, 8th Week post treatment and 16th Week post treatment using digital spirometer.
Change in Forced Vital Capacity (FVC)
时间窗: 16 Weeks
Forced Vital Capacity (FVC) measured at baseline, 8th Week post treatment and 16th Week post treatment using a digital spirometer.
Change in Body Mass Index (BMI)
时间窗: 16 Weeks
Body Mass Index (BMI) measured at baseline, 8th Week post treatment and 16th Week post treatment. BMI is calculated using height (m) and weight (kg) using the formula kg/m\^2
Change in Serum High Density Lipoprotein (LDL-C)
时间窗: 16 Weeks
Serum High Density Lipoprotein (LDL-C) measured at baseline, 8th Week post treatment and 16th Week post treatment from intravenous blood specimen.
Change in Waist-Hip Ratio
时间窗: 16 Weeks
Waist-Hip Ratio measured at baseline, 8th Week post treatment and 16th Week post treatment. Waist and hip circumference will be measured using inelastic tape.
Change in Level of Perceived Exertion
时间窗: 16 Weeks
Level of Perceived Exertion measured at baseline, 8th Week post treatment and 16th Week post treatment using BROG scale.
Change in Serum Triglycerides
时间窗: 16 Weeks
Serum Triglycerides measured at baseline, 8th Week post treatment and 16th Week post treatment
Change in Hand Grip Strength
时间窗: 16 Weeks
Hand Grip Strength (Dominant \& Non Dominant)measured at baseline, 8th Week post treatment and 16th Week post treatment using Hand Held Dynamometer.
Change in Blood Pressure
时间窗: 16 Weeks
Office, Ambulatory, Daytime, Nighttime \& 24 hours Systolic \& Diastolic Blood Pressure, Mean Arterial Blood Pressure measured at baseline, 8th Week post treatment and 16th Week post treatment
Change in Serum High Density Lipoprotein (HDL-C)
时间窗: 16 Weeks
Serum High Density Lipoprotein (HDL-C) measured at baseline, 8th Week post treatment and 16th Week post treatment from intravenous blood specimen.
Change in Peak Expiratory Flow Rate (PEFR)
时间窗: 16 Weeks
Peak Expiratory Flow Rate (PEFR) measured at baseline, 8th Week post treatment and 16th Week post treatment using digital spirometer.
Change in VO2 Maximum
时间窗: 16 Weeks
VO2 Maximum measured at baseline, 8th Week post treatment and 16th Week post treatment using treadmill.
Change in Body Fat Percentage
时间窗: 16 Weeks
Body Fat Percentage measured at baseline, 8th Week post treatment and 16th Week post treatment using a body fat analyzer
次要结局
未报告次要终点