Clinical trial NCT05409456: Comparative Effects of Mild and Moderate Aerobic Exercises on BP, VO2 and HR in Hypertensive Patients
Official title: Comparative Effects of Mild and Moderate Aerobic Exercises on Blood Pressure, Oxygen Saturation and Heart Rate in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: HTN hypertension
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups group A is assign mild aerobic group b is assign moderate aerobic
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: World Health Organization, when systolic blood pressure is equal to or above 130 mm Hg and/or a diastolic blood pressure equal to or above 85 mm Hg , the blood pressure is considered to be raised or high is called hypertension." Most people with hypertension have no symptoms at all; this is why it is known as the "silent killer".

More than 1 in 5 adults worldwide had raised blood pressure. There has been studies on strength exercise, severe aerobic exercise and other types of exercises and on their effects on blood pressure, heart rate and oxygen saturation in other patient populations and on healthy individuals as well, but in the patients with hypertension no comparison has been made between mild and moderate aerobic exercise (tread mill) yet, stating which one is effective. Secondly, already present studies have shown long term effects mostly, not the comparative effects of mild and moderate exercises on blood pressure heart rate and oxygen saturation of patients with hypertension. These techniques are inexpensive, easy to perform and contain no known harmful effect. Hence, current study will undertake this task of finding out what are the comparative effects of mild and moderate aerobic on the BP, heart rate and oxygen saturation and secondly which technique is more effective. Study design will Randomized clinical trial with non-probability convenient sampling.

It will be single blinded study with blinding of assessor. Sample size was calculated from Epitools website and will be 28. There will be two groups which will be randomly assigned 14 people using lottery method. Data will be collected from community dwelling areas of Lahore Patients with hypertension with Systolic Blood Pressure 130 - 159 mmHg and Diastolic Blood Pressure 85 - 99 mmHg (pre hypertensive and stage 1), 30 to 50 years of age, patients who have taken any antihypertensive medicine in more than 6 hours and both males and females will be recruited. Tools will be aneroid sphygmomanometer for measuring blood pressure and pulse oximeter for measuring oxygen saturation and heart rate and Post interventional BP, heart rate readings and oxygen saturation will be taken for both groups on the same day.

Post intervention blood pressure, Heart rate and oxygen saturation will be taken after 5 minutes.

Detailed description: World Health Organization, when systolic blood pressure is equal to or above 130 mm Hg and/or a diastolic blood pressure equal to or above 85 mm Hg , the blood pressure is considered to be raised or high is called hypertension." Most people with hypertension have no symptoms at all; this is why it is known as the "silent killer".

More than 1 in 5 adults worldwide had raised blood pressure. There has been studies on strength exercise, severe aerobic exercise and other types of exercises and on their effects on blood pressure, heart rate and oxygen saturation in other patient populations and on healthy individuals as well, but in the patients with hypertension no comparison has been made between mild and moderate aerobic exercise (tread mill) yet, stating which one is effective. Secondly, already present studies have shown long term effects mostly, not the comparative effects of mild and moderate exercises on blood pressure heart rate and oxygen saturation of patients with hypertension. These techniques are inexpensive, easy to perform and contain no known harmful effect. Hence, current study will undertake this task of finding out what are the comparative effects of mild and moderate aerobic on the BP, heart rate and oxygen saturation and secondly which technique is more effective. Study design will Randomized clinical trial with non-probability convenient sampling.

It will be single blinded study with blinding of assessor. Sample size was calculated from Epitools website and will be 28. There will be two groups which will be randomly assigned 14 people using lottery method. Data will be collected from community dwelling areas of Lahore Patients with hypertension with Systolic Blood Pressure 130 - 159 mmHg and Diastolic Blood Pressure 85 - 99 mmHg (pre hypertensive and stage 1), 30 to 50 years of age, patients who have taken any antihypertensive medicine in more than 6 hours and both males and females will be recruited. Tools will be aneroid sphygmomanometer for measuring blood pressure and pulse oximeter for measuring oxygen saturation and heart rate and Post interventional BP, heart rate readings and oxygen saturation will be taken for both groups on the same day.

Post intervention blood pressure, Heart rate and oxygen saturation will be taken after 5 minutes. Key words: HTN hypertension, HR heart rate, BP blood pressure, vo2max maximum oxygen uptake in unit of time.

Eligibility criteria: Inclusion Criteria:

* Age: 40 to 55
* Gender: male and female
* Chronic hypertensive stable patients (130 - 159mmHg / 85 - 99mmHg) (3)
* History of hypertension from last 1 year(14)
* Taking anti-hypertensive medicines (ACE inhibitors, calcium channel blockers, thiazide diuretics, ACE receptor inhibitors, beta blockers) more than 6 hours ago

Exclusion Criteria:

History of ischemia

* History of stroke
* Chronic obstructive and restrictive disease
* Hypo and hypernatremia
* Joint disease patients
* Lower limb fracture
* Chronic atrial fibrillation
* Change in drug therapy

Primary outcomes:
measure: blood pressure
timeFrame: 6 weeks
Secondary outcomes:
measure: oxygen saturation
timeFrame: 6 weeks
measure: heart rate
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabilitation Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Tasneem Shehzadi, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Roque FR, Briones AM, Garcia-Redondo AB, Galan M, Martinez-Revelles S, Avendano MS, Cachofeiro V, Fernandes T, Vassallo DV, Oliveira EM, Salaices M. Aerobic exercise reduces oxidative stress and improves vascular changes of small mesenteric and coronary arteries in hypertension. Br J Pharmacol. 2013 Feb;168(3):686-703. doi: 10.1111/j.1476-5381.2012.02224.x.
citation: Westhoff TH, Schmidt S, Gross V, Joppke M, Zidek W, van der Giet M, Dimeo F. The cardiovascular effects of upper-limb aerobic exercise in hypertensive patients. J Hypertens. 2008 Jul;26(7):1336-42. doi: 10.1097/HJH.0b013e3282ffac13.
citation: Ciolac EG, Guimaraes GV, D'Avila VM, Bortolotto LA, Doria EL, Bocchi EA. Acute aerobic exercise reduces 24-h ambulatory blood pressure levels in long-term-treated hypertensive patients. Clinics (Sao Paulo). 2008 Dec;63(6):753-8. doi: 10.1590/s1807-59322008000600008.