Hypertension,EssentialNCT06282302
Effect of Isometric and Aerobic Physical Exercise on Blood Pressure Levels in Hypertensive Elderly People
A study testing Isometric Exercise and Aerobic Exercise in people with Hypertension,Essential and Hypertension, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Hypertension,Essential, Hypertension
- What is being tested?
- Isometric Exercise and Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jan 2024to 30 Apr 2024
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Institute of Cardiology
Porto Alegre, Rio Grande do Sul, 900.620-000
Lidiane P Stochero, 5554981301920, lidistochero3@gmail.com
About this study
Official title: Effect of Isometric and Aerobic Physical Exercise on Blood Pressure Levels in Hypertensive Elderly People: Randomized Clinical Trial
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.
Read the detailed 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.
- Conditions
- Hypertension,Essential, Hypertension
- Being tested
- Group control, Isometric Exercise, Aerobic Exercise
- Keywords
- hypertension, isometric exercise, aerobic exercise
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group controlOther
Group control The control session will consist of keeping the volunteer sitting in a calm, air-conditioned environment for 40 minutes.
Isometric ExerciseOther
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 ExerciseOther
Volunteers will perform 50 minutes of horizontal exercise cycling (brand: pro-user), continuously and at moderate intensity (50% to 60% of HR reserve).
| Study group | Role | What they receive |
|---|---|---|
| Group control | Experimental | The control session will consist of keeping the volunteer sitting in a calm, air-conditioned environment for 40 minutes. Receives: 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. Receives: 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). Receives: Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until completion of the study, on average 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start20 Jan 2024
- Primary completion18 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LIDIANE P STOCHERO, Principal investigator, University Foundation of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282302
- Sponsor's protocol ID
- 6030/22
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summary Study protocol Statistical Analysis Plan (SAP) Free and Informed Consent Form (TCLE) Clinical Study Report (CSR)
Publications
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.
PubMed 36379974Saco-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.
PubMed 34719262Pescatello 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.
PubMed 15076798Waclawovsky 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.
PubMed 34008818Pescatello 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.
PubMed 12595857Pescatello 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.
PubMed 11689735Baross 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.
PubMed 24379707Ash 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.
PubMed 27861249
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isometric and Aerobic Physical Exercise on Blood Pressure Levels in Hypertensive Elderly People: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06282302
- Acronym / sponsor ID
- 6030/22
- Conditions
- Hypertension,Essential, Hypertension
- Keywords
- hypertension, isometric exercise, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 18 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 28 Feb 2024 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group control | Experimental | Other: Group controlThe control session will consist of keeping the volunteer sitting in a calm, air-conditioned environment for 40 minutes. |
| Isometric Exercise | Experimental | Other: Isometric ExerciseThe 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 | Experimental | Other: Aerobic ExerciseVolunteers will perform 50 minutes of horizontal exercise cycling (brand: pro-user), continuously and at moderate intensity (50% to 60% of HR reserve). |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| Group controlGroup control The control session will consist of keeping the volunteer sitting in a calm, air-conditioned environment for 40 minutes. | Other | Group control |
| Isometric ExerciseThe 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 ExerciseVolunteers 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 |
Primary outcome
24-hour Ambulatory Blood Pressure Monitoring
Time frame: Until completion of the study, on average 4 months.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 36379974Oliveira 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.
- Background: PubMed 34719262Saco-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.
- Background: PubMed 15076798Pescatello 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.
- Background: PubMed 34008818Waclawovsky 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.
- Background: PubMed 12595857Pescatello 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.
- Background: PubMed 11689735Pescatello 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.
- Background: PubMed 24379707Baross 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.
- Background: PubMed 27861249Ash 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.
- Individual participant dataSharing planned: Yes. Summary Study protocol Statistical Analysis Plan (SAP) Free and Informed Consent Form (TCLE) Clinical Study Report (CSR)
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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.
LIDIANE P STOCHERO principal investigator
University Foundation of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Exercise and Aerobic Exercise in people with Hypertension,Essential and Hypertension, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Feb 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 Brazil. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LIDIANE PAIVA STOCHERO P STOCHERO, higher (5554981301920, lidistochero3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour Ambulatory Blood Pressure Monitoring (time frame: Until completion of the study, on average 4 months.). 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 NCT06282302, which also lists 8 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 28 Feb 2024.