Effect of Isometric and Aerobic Physical Exercise on Blood Pressure Levels in Hypertensive Elderly People

Hypertension Clinical Trial

Official title:

Effect of Isometric and Aerobic Physical Exercise on Blood Pressure Levels in Hypertensive Elderly People: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282302
• Other study ID #: 6030/22
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: LIDIANE PAIVA STOCHERO P STOCHERO, higher
• Phone: 5554981301920
• Email: lidistochero3[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: Adequate blood pressure control is necessary to reduce the risk of mortality from cardiovascular events. The effects of aerobic exercise on systemic arterial hypertension are already well known, however, to date, there is little evidence regarding the effect of an isometric exercise session for the lower limbs on blood pressure levels, especially when performed in elderly hypertensive individuals. Objective: To verify the effect of an isometric or aerobic exercise protocol for the lower limbs on 24-hour ambulatory blood pressure in elderly hypertensive individuals.

Description:

Introduction: Adequate blood pressure control is necessary to reduce the risk of mortality from cardiovascular events. The effects of aerobic exercise on systemic arterial hypertension are already well known, however, to date, there is little evidence regarding the effect of an isometric exercise session for the lower limbs on blood pressure levels, especially when performed in elderly hypertensive individuals. Objective: To verify the effect of an isometric or aerobic exercise protocol for the lower limbs on 24-hour ambulatory blood pressure in elderly hypertensive individuals. Methods: Thirty-six controlled hypertensive volunteers, aged ≥ 60 years, of both sexes, will be randomly selected based on their medical records. Volunteers will be randomized to perform an isometric wall squat exercise session (n=12 - 4 repetitions of 2 minutes of execution and 2 minutes of rest, performed at a specific angle of the volunteer's knee joint - Borg scale of 11 to 13 points - moderate intensity) or an aerobic exercise session on a stationary bike (n=12 - 40 minutes and at moderate intensity stipulated between the range of 50% to 60% of HR reserve and Borg scale of 11 to 13 points - moderate intensity) or a control session without exercise, 40 minutes per session (n=12). 24-hour Ambulatory Blood Pressure Monitoring will be performed pre- and post-session. Statistical analyzes will be performed using the ANOVA test (one way), power of 80% and alpha 95%, SPSS-26.0.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 30, 2024
• Est. primary completion date: March 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• Hypertensive elderly;
• Both genders;
• Aged = 60 years;
• Hypertensive patients on continuous use of antihypertensive medication;
• Hypertensive who did not practice physical exercise regularly (= 2 sessions per week).

Exclusion Criteria:

• Those who presented one of the following issues will be excluded:
• Diabetes mellitus;
• Chronic renal failure;
• Body mass index (BMI) = 35 kg/m2;
• Coronary artery disease;
• Heart failure;
• Any injury to the lower limbs;
• Smokers.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Hypertension,Essential

Intervention

Other:
• Group control
Group control The control session will consist of keeping the volunteer sitting in a calm, air-conditioned environment for 40 minutes.
• Isometric Exercise
The intervention with isometric exercise for the lower limbs, the volunteers will start in a vertical position, with shoulders and hips in contact with the wall, feet parallel and shoulder-width apart and hands at the sides of the body. Then (second phase), the volunteers, maintaining contact with the wall, squatted and advanced their feet in the desired position until the knee joint angle reached the previously determined value. The third phase referred directly to the isometric effort of the isometric exercise session. For the isometric wall squat exercise session, volunteers will be asked to perform 4 repetitions of 2 minutes, with a 2-minute rest interval in a seated position for adequate rest between each repetition.
• Aerobic Exercise
Volunteers will perform 50 minutes of horizontal exercise cycling (brand: pro-user), continuously and at moderate intensity (50% to 60% of HR reserve).

Locations

Country	Name	City	State
Brazil	Institute of Cardiology	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Ash GI, Taylor BA, Thompson PD, MacDonald HV, Lamberti L, Chen MH, Farinatti P, Kraemer WJ, Panza GA, Zaleski AL, Deshpande V, Ballard KD, Mujtaba M, White CM, Pescatello LS. The antihypertensive effects of aerobic versus isometric handgrip resistance exercise. J Hypertens. 2017 Feb;35(2):291-299. doi: 10.1097/HJH.0000000000001176. — View Citation

Baross AW, Wiles JD, Swaine IL. Double-leg isometric exercise training in older men. Open Access J Sports Med. 2013 Jan 30;4:33-40. doi: 10.2147/OAJSM.S39375. eCollection 2013. — View Citation

Oliveira PC, Silva MR, Lehnen AM, Waclawovsky G. Isometric handgrip training, but not a single session, reduces blood pressure in individuals with hypertension: a systematic review and meta-analysis. J Hum Hypertens. 2023 Sep;37(9):844-853. doi: 10.1038/s41371-022-00778-7. Epub 2022 Nov 15. — View Citation

Pescatello LS, Bairos L, Vanheest JL, Maresh CM, Rodriguez NR, Moyna NM, DiPasquale C, Collins V, Meckes CL, Krueger L, Thompson PD. Postexercise hypotension differs between white and black women. Am Heart J. 2003 Feb;145(2):364-70. doi: 10.1067/mhj.2003.107. — View Citation

Pescatello LS, Franklin BA, Fagard R, Farquhar WB, Kelley GA, Ray CA; American College of Sports Medicine. American College of Sports Medicine position stand. Exercise and hypertension. Med Sci Sports Exerc. 2004 Mar;36(3):533-53. doi: 10.1249/01.mss.0000115224.88514.3a. — View Citation

Pescatello LS, Kulikowich JM. The aftereffects of dynamic exercise on ambulatory blood pressure. Med Sci Sports Exerc. 2001 Nov;33(11):1855-61. doi: 10.1097/00005768-200111000-00009. — View Citation

Saco-Ledo G, Valenzuela PL, Ramirez-Jimenez M, Morales JS, Castillo-Garcia A, Blumenthal JA, Ruilope LM, Lucia A. Acute Aerobic Exercise Induces Short-Term Reductions in Ambulatory Blood Pressure in Patients With Hypertension: A Systematic Review and Meta-Analysis. Hypertension. 2021 Dec;78(6):1844-1858. doi: 10.1161/HYPERTENSIONAHA.121.18099. Epub 2021 Nov 1. — View Citation

Waclawovsky G, Pedralli ML, Eibel B, Schaun MI, Lehnen AM. Effects of Different Types of Exercise Training on Endothelial Function in Prehypertensive and Hypertensive Individuals: A Systematic Review. Arq Bras Cardiol. 2021 May;116(5):938-947. doi: 10.36660/abc.20190807. English, Portuguese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour Ambulatory Blood Pressure Monitoring	Check 24-hour blood pressure levels (24-hour Ambulatory Blood Pressure Monitoring) obtained after an isometric squat session in elderly individuals with SAH and compare BP levels after an exercise session on a stationary bike and the control group.	Until completion of the study, on average 4 months.