Pre HypertensionNCT04841902
Effects of Life Style Intervention Manual in Pre Hypertensive Sedentary Population
A study testing Life Style Intervention Manual (With Exercise Under Supervision), General Advice and Life Style Intervention Manual (Home Based) in people with Pre Hypertension, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre Hypertension
- What is being tested?
- Life Style Intervention Manual (With Exercise Under Supervision), General Advice and Life Style Intervention Manual (Home Based)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Pre Hypertension
- Being tested
- Life Style Intervention Manual (With Exercise Under Supervision), General Advice, Life Style Intervention Manual (Home Based)
- Keywords
- Pre Hypertension, Lifestyle Intervention, Metabolic parameters, Cardiovascular parameters, Respiratory parameters, Physical parameters
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
General AdviceOther
General advice to stay healthy and active
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: General Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 Weeks
Change in Serum Triglycerides
Serum Triglycerides measured at baseline, 8th Week post treatment and 16th Week post treatment
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 16 Weeks
Change in VO2 Maximum
VO2 Maximum measured at baseline, 8th Week post treatment and 16th Week post treatment using treadmill.
Measured: 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.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Jul 2021
- Primary completion30 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pre HypertensionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danish Hassan, PhD*, Principal investigator, Riphah International UniversitySyed Shakil ur Rehman, PhD, Study director, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841902
- Sponsor's protocol ID
- REC/Lhr/21/1101 Danish Hassan
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25687599Mills 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.
PubMed 27502908Park 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.
PubMed 25503845Lee 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.
PubMed 29968437Gerber 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.
PubMed 31221205Zheng 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.
PubMed 31448373Zhang 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.
PubMed 32080136
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Life Style Intervention Manual on Metabolic, Cardiovascular, Respiratory and Physical Parameters in Pre Hypertensive Sedentary Population
- ClinicalTrials.gov ID
- NCT04841902
- Acronym / sponsor ID
- REC/Lhr/21/1101 Danish Hassan
- Conditions
- Pre Hypertension
- Keywords
- Pre Hypertension, Lifestyle Intervention, Metabolic parameters, Cardiovascular parameters, Respiratory parameters, Physical parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Life Style Intervention Manual (Supervised) | Experimental | Other: Life Style Intervention Manual (With Exercise Under Supervision)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 |
| Life Style Intervention Manual (Home Based) | Experimental | Other: 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 |
| Control | Placebo comparator | Other: General AdviceAge matched Control Group followed for 16 weeks with General Advise to stay healthy and active |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Life Style Intervention Manual (Supervised) |
| General AdviceGeneral advice to stay healthy and active | Other | Control |
| 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. | Other | Life Style Intervention Manual (Home Based) |
Primary outcome
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
Change in Serum Triglycerides
Time frame: 16 Weeks
Serum Triglycerides measured at baseline, 8th Week post treatment and 16th Week post treatment
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
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
Change in VO2 Maximum
Time frame: 16 Weeks
VO2 Maximum measured at baseline, 8th Week post treatment and 16th Week post treatment using treadmill.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 25687599AlGhatrif 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.
- Background: PubMed 27502908Mills 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.
- Background: PubMed 25503845Park 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.
- Background: PubMed 29968437Lee 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.
- Background: PubMed 31221205Gerber 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.
- Background: PubMed 31448373Zheng 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.
- Background: PubMed 32080136Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danish Hassan, PhD* principal investigator
Riphah International University
Syed Shakil ur Rehman, PhD study director
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Style Intervention Manual (With Exercise Under Supervision), General Advice and Life Style Intervention Manual (Home Based) in people with Pre Hypertension, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Pressure (time frame: 16 Weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841902, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.