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Effects of Life Style Intervention Manual in Pre Hypertensive Sedentary Population

Primary Purpose

Pre Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Life Style Intervention Manual (With Exercise Under Supervision)
General Advice
Life Style Intervention Manual (Home Based)
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre Hypertension focused on measuring Pre Hypertension, Lifestyle Intervention, Metabolic parameters, Cardiovascular parameters, Respiratory parameters, Physical parameters

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Riphah Rehabiliation ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Life Style Intervention Manual (Supervised)

Life Style Intervention Manual (Home Based)

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
Change in Serum Triglycerides
Serum Triglycerides measured at baseline, 8th Week post treatment and 16th Week post treatment
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
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.
Change in Serum Total Cholesterol
Serum Total Cholesterol measured at baseline, 8th Week post treatment and 16th Week post treatment from intravenous blood specimen.
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.
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.
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.
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.
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.
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
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.
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.
Change in VO2 Maximum
VO2 Maximum measured at baseline, 8th Week post treatment and 16th Week post treatment using treadmill.
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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2021
Last Updated
March 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04841902
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Hypertension
Keywords
Pre Hypertension, Lifestyle Intervention, Metabolic parameters, Cardiovascular parameters, Respiratory parameters, Physical parameters

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Life Style Intervention Manual (Supervised)
Arm Type
Experimental
Arm Description
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
Arm Title
Life Style Intervention Manual (Home Based)
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Age matched Control Group followed for 16 weeks with General Advise to stay healthy and active
Intervention Type
Other
Intervention Name(s)
Life Style Intervention Manual (With Exercise Under Supervision)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
General Advice
Intervention Description
General advice to stay healthy and active
Intervention Type
Other
Intervention Name(s)
Life Style Intervention Manual (Home Based)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Blood Pressure
Description
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
Time Frame
16 Weeks
Title
Change in Serum Triglycerides
Description
Serum Triglycerides measured at baseline, 8th Week post treatment and 16th Week post treatment
Time Frame
16 Weeks
Title
Change in Body Mass Index (BMI)
Description
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
Time Frame
16 Weeks
Title
Change in Forced Vital Capacity (FVC)
Description
Forced Vital Capacity (FVC) measured at baseline, 8th Week post treatment and 16th Week post treatment using a digital spirometer.
Time Frame
16 Weeks
Title
Change in Serum Total Cholesterol
Description
Serum Total Cholesterol measured at baseline, 8th Week post treatment and 16th Week post treatment from intravenous blood specimen.
Time Frame
16 Weeks
Title
Change in Serum High Density Lipoprotein (HDL-C)
Description
Serum High Density Lipoprotein (HDL-C) measured at baseline, 8th Week post treatment and 16th Week post treatment from intravenous blood specimen.
Time Frame
16 Weeks
Title
Change in Serum High Density Lipoprotein (LDL-C)
Description
Serum High Density Lipoprotein (LDL-C) measured at baseline, 8th Week post treatment and 16th Week post treatment from intravenous blood specimen.
Time Frame
16 Weeks
Title
Change in Forced Expiratory Volume - 01 Second (FEV1)
Description
Forced Expiratory Volume - 01 Second (FEV1) measured at baseline, 8th Week post treatment and 16th Week post treatment using digital spirometer.
Time Frame
16 Weeks
Title
Change in Forced Expiratory Volume 1 Second / Forced Vital Capacity (FEV1/FVC)
Description
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.
Time Frame
16 Weeks
Title
Change in Peak Expiratory Flow Rate (PEFR)
Description
Peak Expiratory Flow Rate (PEFR) measured at baseline, 8th Week post treatment and 16th Week post treatment using digital spirometer.
Time Frame
16 Weeks
Title
Change in Body Fat Percentage
Description
Body Fat Percentage measured at baseline, 8th Week post treatment and 16th Week post treatment using a body fat analyzer
Time Frame
16 Weeks
Title
Change in Waist-Hip Ratio
Description
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.
Time Frame
16 Weeks
Title
Change in Hand Grip Strength
Description
Hand Grip Strength (Dominant & Non Dominant)measured at baseline, 8th Week post treatment and 16th Week post treatment using Hand Held Dynamometer.
Time Frame
16 Weeks
Title
Change in VO2 Maximum
Description
VO2 Maximum measured at baseline, 8th Week post treatment and 16th Week post treatment using treadmill.
Time Frame
16 Weeks
Title
Change in Level of Perceived Exertion
Description
Level of Perceived Exertion measured at baseline, 8th Week post treatment and 16th Week post treatment using BROG scale.
Time Frame
16 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danish Hassan, PhD*
Phone
92 345 7946009
Email
danish.hassan@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Syed Shakil ur Rehman, PhD
Phone
92 320 7866611
Email
shakil.urrehman@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danish Hassan, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Syed Shakil ur Rehman, PhD
Organizational Affiliation
Riphah International University
Official's Role
Study Director
Facility Information:
Facility Name
Riphah Rehabiliation Clinic
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54770
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danish Hassan, PhD*
Phone
03457946009
Email
danish.hassan@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Danish Hassan, PhD*

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25687599
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.
Results Reference
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PubMed Identifier
27502908
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.
Results Reference
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PubMed Identifier
25503845
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.
Results Reference
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PubMed Identifier
29968437
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.
Results Reference
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PubMed Identifier
31221205
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.
Results Reference
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PubMed Identifier
31448373
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.
Results Reference
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PubMed Identifier
32080136
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.
Results Reference
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Effects of Life Style Intervention Manual in Pre Hypertensive Sedentary Population

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