NCT05409456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

May 26, 2022

Last Update Submit

December 7, 2022

Conditions

Keywords

HTN hypertension

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    measuring blood pressure by Manual Sphygmomanometer BP apparatus: is the instrument which is used to measure blood pressure if systolic blood pressure is greater than 120 mmHg and diastolic is higher than 90 mmHg is considered hypertensive. Cuff is apply on dominant hand inflate the cuff if sound is appear that is systolic if sound is not hear that is diastolic blood pressure in mmHg.

    6 weeks

Secondary Outcomes (2)

  • oxygen saturation

    6 weeks

  • heart rate

    6 weeks

Study Arms (2)

mild aerobic exercise

EXPERIMENTAL

group A was given mild aerobic exercise on treadmill with warm up exercise

Other: mild aerobic exercise

moderate aerobic exercise

EXPERIMENTAL

group B was moderate aerobic on treadmill with warm up exercise

Other: moderate aerobic exercise

Interventions

mild aerobic exercise given to group A on treadmill

Also known as: aerobic
mild aerobic exercise

moderate aerobic exercise given to group B on treadmill

Also known as: aerobic
moderate aerobic exercise

Eligibility Criteria

Age30 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsboth male and female are included
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (9)

  • Clausen JP, Klausen K, Rasmussen B, Trap-Jensen J. Central and peripheral circulatory changes after training of the arms or legs. Am J Physiol. 1973 Sep;225(3):675-82. doi: 10.1152/ajplegacy.1973.225.3.675. No abstract available.

    PMID: 4726503BACKGROUND
  • Cao L, Li X, Yan P, Wang X, Li M, Li R, Shi X, Liu X, Yang K. The effectiveness of aerobic exercise for hypertensive population: A systematic review and meta-analysis. J Clin Hypertens (Greenwich). 2019 Jul;21(7):868-876. doi: 10.1111/jch.13583. Epub 2019 Jun 6.

    PMID: 31169988BACKGROUND
  • Nascimento LS, Santos AC, Lucena J, Silva L, Almeida A, Brasileiro-Santos MS. Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial. Trials. 2017 Jun 2;18(1):250. doi: 10.1186/s13063-017-1985-5.

    PMID: 28578691BACKGROUND
  • Wen H, Wang L. Reducing effect of aerobic exercise on blood pressure of essential hypertensive patients: A meta-analysis. Medicine (Baltimore). 2017 Mar;96(11):e6150. doi: 10.1097/MD.0000000000006150.

    PMID: 28296729BACKGROUND
  • Dimeo F, Pagonas N, Seibert F, Arndt R, Zidek W, Westhoff TH. Aerobic exercise reduces blood pressure in resistant hypertension. Hypertension. 2012 Sep;60(3):653-8. doi: 10.1161/HYPERTENSIONAHA.112.197780. Epub 2012 Jul 16.

    PMID: 22802220BACKGROUND
  • Weinstein AA, Chin LM, Keyser RE, Kennedy M, Nathan SD, Woolstenhulme JG, Connors G, Chan L. Effect of aerobic exercise training on fatigue and physical activity in patients with pulmonary arterial hypertension. Respir Med. 2013 May;107(5):778-84. doi: 10.1016/j.rmed.2013.02.006. Epub 2013 Mar 7.

    PMID: 23478192BACKGROUND
  • 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.

    PMID: 22994554BACKGROUND
  • 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.

    PMID: 18551008BACKGROUND
  • 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.

    PMID: 19060996BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Tasneem Shehzadi, Mphil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
assessor is blind
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: two groups group A is assign mild aerobic group b is assign moderate aerobic
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 8, 2022

Study Start

May 11, 2022

Primary Completion

August 15, 2022

Study Completion

August 15, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations