Clinical trial NCT04841902: Effects of Life Style Intervention Manual in Pre Hypertensive Sedentary Population
Official title: Effects of Life Style Intervention Manual on Metabolic, Cardiovascular, Respiratory and Physical Parameters in Pre Hypertensive Sedentary Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Hypertension
Keywords: Pre Hypertension
Lifestyle Intervention
Metabolic parameters
Cardiovascular parameters
Respiratory parameters
Physical parameters
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 240
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Aged between 25 - 40 years
2. Either gender
3. Clinic BP will be consistent with the diagnosis of pre-hypertension
4. Sedentary Subjects (\<150 min/week or \<600 MET-min/week on IPAQ Urdu Version)

Exclusion Criteria:

1. Body Mass Index less than 18.5 kg/m2 or greater than 45 kg/m2
2. Evidence of target organ damage such as left ventricular hypertrophy, angina, heart failure, stroke, chronic kidney disease, peripheral artery disease
3. Women of child-bearing age who tested positive for HCG \& breastfeeding women
4. Individuals who could not read the consent or Participated in another study within 3 months

Primary outcomes:
measure: Change in Blood Pressure
timeFrame: 16 Weeks
measure: Change in Serum Triglycerides
timeFrame: 16 Weeks
measure: Change in Body Mass Index (BMI)
timeFrame: 16 Weeks
measure: Change in Forced Vital Capacity (FVC)
timeFrame: 16 Weeks
measure: Change in Serum Total Cholesterol
timeFrame: 16 Weeks
measure: Change in Serum High Density Lipoprotein (HDL-C)
timeFrame: 16 Weeks
measure: Change in Serum High Density Lipoprotein (LDL-C)
timeFrame: 16 Weeks
measure: Change in Forced Expiratory Volume - 01 Second (FEV1)
timeFrame: 16 Weeks
measure: Change in Forced Expiratory Volume 1 Second / Forced Vital Capacity (FEV1/FVC)
timeFrame: 16 Weeks
measure: Change in Peak Expiratory Flow Rate (PEFR)
timeFrame: 16 Weeks
measure: Change in Body Fat Percentage
timeFrame: 16 Weeks
measure: Change in Waist-Hip Ratio
timeFrame: 16 Weeks
measure: Change in Hand Grip Strength
timeFrame: 16 Weeks
measure: Change in VO2 Maximum
timeFrame: 16 Weeks
measure: Change in Level of Perceived Exertion
timeFrame: 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabiliation Clinic
state: Punjab
Study officials:
affiliation: Riphah International University
name: Danish Hassan, PhD*
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Syed Shakil ur Rehman, PhD
role: STUDY_DIRECTOR
References:
citation: AlGhatrif M, Lakatta EG. The conundrum of arterial stiffness, elevated blood pressure, and aging. Curr Hypertens Rep. 2015 Feb;17(2):12. doi: 10.1007/s11906-014-0523-z.
citation: Mills KT, Bundy JD, Kelly TN, Reed JE, Kearney PM, Reynolds K, Chen J, He J. Global Disparities of Hypertension Prevalence and Control: A Systematic Analysis of Population-Based Studies From 90 Countries. Circulation. 2016 Aug 9;134(6):441-50. doi: 10.1161/CIRCULATIONAHA.115.018912.
citation: Park JB, Kario K, Wang JG. Systolic hypertension: an increasing clinical challenge in Asia. Hypertens Res. 2015 Apr;38(4):227-36. doi: 10.1038/hr.2014.169. Epub 2014 Dec 11.
citation: Lee CJ, Kim JY, Shim E, Hong SH, Lee M, Jeon JY, Park S. The Effects of Diet Alone or in Combination with Exercise in Patients with Prehypertension and Hypertension: a Randomized Controlled Trial. Korean Circ J. 2018 Jul;48(7):637-651. doi: 10.4070/kcj.2017.0349.
citation: Gerber M, Beck J, Brand S, Cody R, Donath L, Eckert A, Faude O, Fischer X, Hatzinger M, Holsboer-Trachsler E, Imboden C, Lang U, Mans S, Mikoteit T, Oswald A, Puhse U, Rey S, Schreiner AK, Schweinfurth N, Spitzer U, Zahner L. The impact of lifestyle Physical Activity Counselling in IN-PATients with major depressive disorders on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers: study protocol for a randomized controlled trial. Trials. 2019 Jun 20;20(1):367. doi: 10.1186/s13063-019-3468-3.
citation: Zheng S, Lubin B, Au R, Murabito JM, Benjamin EJ, Shwartz M. Advantages of Continuous-Valued Risk Scores for Predicting Long-Term Costs: The Framingham Coronary Heart Disease 10-Year Risk Score. Adv Geriatr Med Res. 2019;1(1):e190004. doi: 10.20900/agmr20190004. Epub 2019 Jun 6.
citation: Zhang C, Zhang Y, Lin H, Liu S, Xie J, Tang Y, Huang H, Zhang W. Blood pressure control in hypertensive patients and its relation with exercise and exercise-related behaviors: A case-control study. Medicine (Baltimore). 2020 Feb;99(8):e19269. doi: 10.1097/MD.0000000000019269.