Effects of Life Style Intervention Manual in Pre Hypertensive Sedentary Population

NCT04841902 | Completed

• 1 other identifier: REC/Lhr/21/1101 Danish Hassan
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre Hypertension

Keywords

Pre Hypertension; Lifestyle Intervention; Metabolic parameters; Cardiovascular parameters; Respiratory parameters; Physical parameters

Outcome Measures

Primary Outcomes (15)

• Change in Blood Pressure

  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

  16 Weeks

• Change in Serum Triglycerides

  Serum Triglycerides measured at baseline, 8th Week post treatment and 16th Week post treatment

  16 Weeks

• Change in Body Mass Index (BMI)

  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

  16 Weeks

• Change in Forced Vital Capacity (FVC)

  Forced Vital Capacity (FVC) measured at baseline, 8th Week post treatment and 16th Week post treatment using a digital spirometer.

  16 Weeks

• Change in Serum Total Cholesterol

  Serum Total Cholesterol measured at baseline, 8th Week post treatment and 16th Week post treatment from intravenous blood specimen.

  16 Weeks

• Change in Serum High Density Lipoprotein (HDL-C)

  Serum High Density Lipoprotein (HDL-C) measured at baseline, 8th Week post treatment and 16th Week post treatment from intravenous blood specimen.

  16 Weeks

• Change in Serum High Density Lipoprotein (LDL-C)

  Serum High Density Lipoprotein (LDL-C) measured at baseline, 8th Week post treatment and 16th Week post treatment from intravenous blood specimen.

  16 Weeks

• Change in Forced Expiratory Volume - 01 Second (FEV1)

  Forced Expiratory Volume - 01 Second (FEV1) measured at baseline, 8th Week post treatment and 16th Week post treatment using digital spirometer.

  16 Weeks

• Change in Forced Expiratory Volume 1 Second / Forced Vital Capacity (FEV1/FVC)

  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.

  16 Weeks

• Change in Peak Expiratory Flow Rate (PEFR)

  Peak Expiratory Flow Rate (PEFR) measured at baseline, 8th Week post treatment and 16th Week post treatment using digital spirometer.

  16 Weeks

• Change in Body Fat Percentage

  Body Fat Percentage measured at baseline, 8th Week post treatment and 16th Week post treatment using a body fat analyzer

  16 Weeks

• Change in Waist-Hip Ratio

  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.

  16 Weeks

• Change in Hand Grip Strength

  Hand Grip Strength (Dominant \& Non Dominant)measured at baseline, 8th Week post treatment and 16th Week post treatment using Hand Held Dynamometer.

  16 Weeks

• Change in VO2 Maximum

  VO2 Maximum measured at baseline, 8th Week post treatment and 16th Week post treatment using treadmill.

  16 Weeks

• Change in Level of Perceived Exertion

  Level of Perceived Exertion measured at baseline, 8th Week post treatment and 16th Week post treatment using BROG scale.

  16 Weeks

Study Arms (3)

Life Style Intervention Manual (Supervised)

EXPERIMENTAL

Supervised Exercises with Life Style Intervention Manual (Dietary \& Educational Component) for 3 days / week for 16 weeks. Each session will comprise of 60 minutes of alternating light to moderate intensity aerobic exercises including warm up and rest interval

Other: Life Style Intervention Manual (With Exercise Under Supervision)

Life Style Intervention Manual (Home Based)

EXPERIMENTAL

Home Based- Life Style Intervention Manual (Exercise, Dietary \& Educational Component for 16 weeks. Subject will be asked to maintain a regular exercise and dietary diary to ensure adherence to the program

Other: Life Style Intervention Manual (Home Based)

Control

PLACEBO COMPARATOR

Age matched Control Group followed for 16 weeks with General Advise to stay healthy and active

Other: General Advice

Interventions

Life Style Intervention Manual (With Exercise Under Supervision) OTHER

Life Style Intervention Manual for Pre Hypertensive subjects will consist of three components; Exercise, Dietary Modification and Education. The exercise will be supervised will other two components will be home based.

Life Style Intervention Manual (Supervised)

General Advice OTHER

General advice to stay healthy and active

Control

Life Style Intervention Manual (Home Based) OTHER

Life Style Intervention Manual for Pre Hypertensive subjects will consist of three components; Exercise, Dietary Modification and Education. All three components will be home based.

Life Style Intervention Manual (Home Based)

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Rehabiliation Clinic

Lahore, Punjab Province, 54770, Pakistan

Location

Related Publications (7)

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  PMID: 25687599 BACKGROUND

• 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.

  PMID: 27502908 BACKGROUND

• 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.

  PMID: 25503845 BACKGROUND

• 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.

  PMID: 29968437 BACKGROUND

• 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.

  PMID: 31221205 BACKGROUND

• 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.

  PMID: 31448373 BACKGROUND

• 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.

  PMID: 32080136 BACKGROUND

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Danish Hassan, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

• Syed Shakil ur Rehman, PhD

  Riphah International University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 12, 2021
• Study Start: July 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)