Effects of Life Style Intervention Manual in Pre Hypertensive Sedentary Population

April 18, 2024 updated by: Riphah International University

Effects of Life Style Intervention Manual on Metabolic, Cardiovascular, Respiratory and Physical Parameters in Pre Hypertensive Sedentary Population

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54770
        • Riphah Rehabiliation Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Life Style Intervention Manual (Supervised)
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 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.
Experimental: Life Style Intervention Manual (Home Based)
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)
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.
Placebo Comparator: Control
Age matched Control Group followed for 16 weeks with General Advise to stay healthy and active
Other: General Advice
General advice to stay healthy and active

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Pressure
Time Frame: 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
16 Weeks
Change in Serum Triglycerides
Time Frame: 16 Weeks
Serum Triglycerides measured at baseline, 8th Week post treatment and 16th Week post treatment
16 Weeks
Change in Body Mass Index (BMI)
Time Frame: 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
16 Weeks
Change in Forced Vital Capacity (FVC)
Time Frame: 16 Weeks
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
Time Frame: 16 Weeks
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)
Time Frame: 16 Weeks
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)
Time Frame: 16 Weeks
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)
Time Frame: 16 Weeks
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)
Time Frame: 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.
16 Weeks
Change in Peak Expiratory Flow Rate (PEFR)
Time Frame: 16 Weeks
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
Time Frame: 16 Weeks
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
Time Frame: 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.
16 Weeks
Change in Hand Grip Strength
Time Frame: 16 Weeks
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
Time Frame: 16 Weeks
VO2 Maximum measured at baseline, 8th Week post treatment and 16th Week post treatment using treadmill.
16 Weeks
Change in Level of Perceived Exertion
Time Frame: 16 Weeks
Level of Perceived Exertion measured at baseline, 8th Week post treatment and 16th Week post treatment using BROG scale.
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Study Director: Syed Shakil ur Rehman, PhD, Riphah International University
  • Principal Investigator: Danish Hassan, PhD*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

April 9, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/Lhr/21/1101 Danish Hassan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pre Hypertension

Clinical Trials on Life Style Intervention Manual (With Exercise Under Supervision)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe