NCT06282302

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

January 20, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

February 28, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

January 19, 2024

Last Update Submit

February 20, 2024

Conditions

Keywords

hypertensionisometric exerciseaerobic exercise

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (3)

Group control

EXPERIMENTAL

The control session will consist of keeping the volunteer sitting in a calm, air-conditioned environment for 40 minutes.

Other: Group control

Isometric Exercise

EXPERIMENTAL

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.

Other: Isometric Exercise

Aerobic Exercise

EXPERIMENTAL

Volunteers will perform 50 minutes of horizontal exercise cycling (brand: pro-user), continuously and at moderate intensity (50% to 60% of HR reserve).

Other: Aerobic Exercise

Interventions

Group control The control session will consist of keeping the volunteer sitting in a calm, air-conditioned environment for 40 minutes.

Group control

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.

Isometric Exercise

Volunteers will perform 50 minutes of horizontal exercise cycling (brand: pro-user), continuously and at moderate intensity (50% to 60% of HR reserve).

Aerobic Exercise

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiology

Porto Alegre, Rio Grande do Sul, 900.620-000, Brazil

RECRUITING

Related Publications (8)

  • 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.

    PMID: 36379974BACKGROUND
  • 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.

    PMID: 34719262BACKGROUND
  • 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.

    PMID: 15076798BACKGROUND
  • 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.

    PMID: 34008818BACKGROUND
  • 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.

    PMID: 12595857BACKGROUND
  • 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.

    PMID: 11689735BACKGROUND
  • 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.

    PMID: 24379707BACKGROUND
  • 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.

    PMID: 27861249BACKGROUND

MeSH Terms

Conditions

Essential HypertensionHypertension

Interventions

Control GroupsExercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • LIDIANE P STOCHERO

    University Foundation of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LIDIANE PAIVA STOCHERO P STOCHERO, higher

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The RCT will involve thirty-six elderly volunteers (≥ 60 years of age) with systemic arterial hypertension, aiming to compare two types of physical exercise sessions, isometric wall squats and an aerobic exercise session on an exercise bike, on the 24-hour blood pressure levels.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2024

First Posted

February 28, 2024

Study Start

January 20, 2024

Primary Completion

March 18, 2024

Study Completion

April 30, 2024

Last Updated

February 28, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Summary Study protocol Statistical Analysis Plan (SAP) Free and Informed Consent Form (TCLE) Clinical Study Report (CSR)

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
3 months
Access Criteria
University Foundation of Cardiology

Locations