Resistant HypertensionNCT06515795
Evaluation of Two Isometric Exercises in the Reduction of the Blood Pressure in People With Resistant Hypertension
A study testing Isometric exercise in people with Resistant Hypertension, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Hypertension remains the main preventable cause of cardiovascular disease (CVD) and all-cause mortality, both in Europe and globally. Resistant hypertension, a severe phenotype of hypertension, is defined as a blood pressure (BP) that remains above the management goal despite using three different antihypertensive… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Isometric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePortugal
- Study dates
- 11 Jul 2024to Sep 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40 to 75 years old, previously diagnosed with resistant hypertension, and on stable medication for at least 6 months.
Who cannot join
- People with secondary hypertension, heart failure, peripheral artery disease, atrial fibrillation, chronic obstructive pulmonary disease or renal failure; people with a cerebro-cardiovascular event in the previous 3 months; people with changes in pharmacological therapy in the previous 6 months; trained people (with regular participation (≥ 2x/week) in exercise training programs in the previous 3 months); people who have any contraindication to exercise; people with neurological and/ or orthopaedic conditions that will interfere with their participation in exercise, such as Parkinson's disease or knee osteoarthritis. Participants with low score (<6) on the MMAS-8 will also be excluded.
Trial locations and contacts
1 site in 1 country.
José Oliveira, PhD contact
Portugal1 site, 1 recruiting
- Recruiting
Local Health Unit of the Aveiro Region
Aveiro
Ana Rita Pereira, MD, ARPereira3@ulsra.min-saude.pt
About this study
Official title: Evaluation of the Safety and Efficacy of Two Isometric Exercises in the Reduction of the Blood Pressure in People With Resistant Hypertension
Hypertension remains the main preventable cause of cardiovascular disease (CVD) and all-cause mortality, both in Europe and globally. Resistant hypertension, a severe phenotype of hypertension, is defined as a blood pressure (BP) that remains above the management goal despite using three different antihypertensive agents of different classes at the maximum or maximum tolerated dose, or controlled BP on four or more antihypertensive medications. Hypertension remains a poorly controlled risk factor on a global scale and the prevalence of resistant hypertension is also growing - it is now estimated to be around 10-20%.
At the moment, there is robust evidence establishing the antihypertensive effects of exercise. The acute reduction of BP after a single bout of exercise is known as post-exercise hypotension.
Read more
In recent years, the number of investigations into the benefits of isometric exercise in the treatment of hypertension has increased, due to its ease of access and potential for use. In a recently published meta-analysis, the authors pointed to isometric exercise as the most effective type of exercise in reducing systolic and diastolic BP.
Given the scarceness of data regarding the safety and efficacy of isometric exercise in individuals with resistant hypertension and since the acute response to exercise may help to identify people who respond to exercise as antihypertensive therapy, the objective of this study is to analyse the acute effect on BP levels of two different isometric exercises - isometric handgrip (IHG) and isometric wall squat (IWS), regarding safety and efficacy, in people with resistant hypertension.
The aim is to analyse if isometric exercises are safe in this population, through the assessment of BP during the execution of the exercises. Besides that, the comparison of IHG and IWS with the control session and between one and another, will help to understand which form of isometric exercise is most effective and has the longest lasting impact on reducing BP.
Each participant must complete an acclimatization session, in which the procedures will be explained, data will be collected and the intensity of IHG and IWS will be assessed. Subsequently, each participant must complete three randomly assigned experimental sessions: a non-exercise control session and two exercise sessions, in which they will follow the protocols currently used in the literature (IHG at 30% of Maximum Voluntary Contraction and IWS at 95% of peak Heart Rate).
- Conditions
- Resistant Hypertension
- Being tested
- Isometric exercise
- Keywords
- resistant hypertension, isometric exercise, handgrip, wall squat, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exerciseOther
In each arm, participants will execute an isometric exercise, in which they will perform 4 repetitions of 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control Session | No intervention | Each participant will remain in a seated position, resting, for 40 minutes. |
| Isometric Handgrip Session | Experimental | After remain in a seated position, resting, for 15 minutes, each participant will perform 4 repetitions of 2 minutes, alternating hands, maintaining the handgrip at a strength value of 30% of the maximal voluntary contraction (MVC) obtained in the initial test, with 1 minute of rest between each repetition. The exercise will be performed in a seated position. Participants will be encouraged to breathe normally and avoid the Valsalva maneuver. Receives: Other: Isometric exercise |
| Isometric Wall Squat Session | Experimental | After remain in a seated position, resting, for 15 minutes, each participant will perform 4 repetitions of 2 minutes, maintaining the squat position with their back against the wall, with 2 minutes of rest (in a seated position) between each repetition. The knee joint angle will be defined using a fixed goniometer attached with Velcro to the thigh and leg. This angle corresponds to the knee position at 95% of the peak HR achieved during the initial incremental test. Participants will be encouraged to breathe normally and avoid the Valsalva maneuver. Receives: Other: Isometric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory Blood Pressure Monitoring
Change from baseline values of Ambulatory Systolic and Dyastolic Blood Pressure Monitoring (in mmHg)
Measured: Blood Pressure (in mmHg) will be assessed 15 minutes after the intervention and then every 20 minutes after each intervention session (exercise sessions and control session) until 12 hours after session
Secondary outcomes (2)
Office Blood Pressure
Systolic and Dyastolic blood pressure (in mmHg) will be measured using automatic oscillometric (change from baseline will be calculated)
Measured: Systolic and Dyastolic BP will be measured immediately before the intervention session, during the exercise sessions (at 30 seconds and 90 seconds of each repetition of the handgrip and the wall squat) and 15 minutes after each intervention session
Adverse Events
Number and severity of adverse events that occur during or after exercise
Measured: Adverse events that occur during the intervention sessions, immediately after the intervention sessions or until 48 hours after the exercise sessions will be recorded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start11 Jul 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Aveiro University
- Responsible party
- Principal investigator, José Luís Silva Lopes, Universidade do Porto
- Investigators
- Fernando Ribeiro, PhD, Study chair, University of AveiroLinda Pescatello, PhD, Study chair, University of ConnecticutAna Rita Pereira, MD, Study chair, Local Health Unit of the Aveiro Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515795
- Sponsor's protocol ID
- IHGvsIWSinResistantHT
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of this article, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Two Isometric Exercises in the Reduction of the Blood Pressure in People With Resistant Hypertension
- ClinicalTrials.gov ID
- NCT06515795
- Acronym / sponsor ID
- IHGvsIWSinResistantHT
- Conditions
- Resistant Hypertension
- Keywords
- resistant hypertension, isometric exercise, handgrip, wall squat, blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Aveiro University
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 23 Jul 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.
Hypertension remains the main preventable cause of cardiovascular disease (CVD) and all-cause mortality, both in Europe and globally. Resistant hypertension, a severe phenotype of hypertension, is defined as a blood pressure (BP) that remains above the management goal despite using three different antihypertensive agents of different classes at the maximum or maximum tolerated dose, or controlled BP on four or more antihypertensive medications. Hypertension remains a poorly controlled risk factor on a global scale and the prevalence of resistant hypertension is also growing - it is now estimated to be around 10-20%.
At the moment, there is robust evidence establishing the antihypertensive effects of exercise. The acute reduction of BP after a single bout of exercise is known as post-exercise hypotension.
In recent years, the number of investigations into the benefits of isometric exercise in the treatment of hypertension has increased, due to its ease of access and potential for use. In a recently published meta-analysis, the authors pointed to isometric exercise as the most effective type of exercise in reducing systolic and diastolic BP.
Given the scarceness of data regarding the safety and efficacy of isometric exercise in individuals with resistant hypertension and since the acute response to exercise may help to identify people who respond to exercise as antihypertensive therapy, the objective of this study is to analyse the acute effect on BP levels of two different isometric exercises - isometric handgrip (IHG) and isometric wall squat (IWS), regarding safety and efficacy, in people with resistant hypertension.
The aim is to analyse if isometric exercises are safe in this population, through the assessment of BP during the execution of the exercises. Besides that, the comparison of IHG and IWS with the control session and between one and another, will help to understand which form of isometric exercise is most effective and has the longest lasting impact on reducing BP.
Each participant must complete an acclimatization session, in which the procedures will be explained, data will be collected and the intensity of IHG and IWS will be assessed. Subsequently, each participant must complete three randomly assigned experimental sessions: a non-exercise control session and two exercise sessions, in which they will follow the protocols currently used in the literature (IHG at 30% of Maximum Voluntary Contraction and IWS at 95% of peak Heart Rate).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Session | No intervention | –Each participant will remain in a seated position, resting, for 40 minutes. |
| Isometric Handgrip Session | Experimental | Other: Isometric exerciseAfter remain in a seated position, resting, for 15 minutes, each participant will perform 4 repetitions of 2 minutes, alternating hands, maintaining the handgrip at a strength value of 30% of the maximal voluntary contraction (MVC) obtained in the initial test, with 1 minute of rest between each repetition. The exercise will be performed in a seated position. Participants will be encouraged to breathe normally and avoid the Valsalva maneuver. |
| Isometric Wall Squat Session | Experimental | Other: Isometric exerciseAfter remain in a seated position, resting, for 15 minutes, each participant will perform 4 repetitions of 2 minutes, maintaining the squat position with their back against the wall, with 2 minutes of rest (in a seated position) between each repetition. The knee joint angle will be defined using a fixed goniometer attached with Velcro to the thigh and leg. This angle corresponds to the knee position at 95% of the peak HR achieved during the initial incremental test. Participants will be encouraged to breathe normally and avoid the Valsalva maneuver. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 40 to 75 years old, previously diagnosed with resistant hypertension, and on stable medication for at least 6 months.
Key exclusion criteria (1 listed)
- People with secondary hypertension, heart failure, peripheral artery disease, atrial fibrillation, chronic obstructive pulmonary disease or renal failure; people with a cerebro-cardiovascular event in the previous 3 months; people with changes in pharmacological therapy in the previous 6 months; trained people (with regular participation (≥ 2x/week) in exercise training programs in the previous 3 months); people who have any contraindication to exercise; people with neurological and/ or orthopaedic conditions that will interfere with their participation in exercise, such as Parkinson's disease or knee osteoarthritis. Participants with low score (<6) on the MMAS-8 will also be excluded.
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 |
|---|---|---|
| Isometric exerciseIn each arm, participants will execute an isometric exercise, in which they will perform 4 repetitions of 2 minutes. | Other | Isometric Handgrip Session, Isometric Wall Squat Session |
Primary outcome
Ambulatory Blood Pressure Monitoring
Time frame: Blood Pressure (in mmHg) will be assessed 15 minutes after the intervention and then every 20 minutes after each intervention session (exercise sessions and control session) until 12 hours after session
Change from baseline values of Ambulatory Systolic and Dyastolic Blood Pressure Monitoring (in mmHg)
2 secondary outcomes
Office Blood Pressure
Time frame: Systolic and Dyastolic BP will be measured immediately before the intervention session, during the exercise sessions (at 30 seconds and 90 seconds of each repetition of the handgrip and the wall squat) and 15 minutes after each intervention session
Adverse Events
Time frame: Adverse events that occur during the intervention sessions, immediately after the intervention sessions or until 48 hours after the exercise sessions will be recorded
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of this article, after deidentification.
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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.
José Oliveira, PhD contact
Fernando Ribeiro, PhD study chair
University of Aveiro
Linda Pescatello, PhD study chair
University of Connecticut
Ana Rita Pereira, MD study chair
Local Health Unit of the Aveiro Region
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 in people with Resistant Hypertension, run by Universidade do Porto at 1 site in Portugal.
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 1 inclusion and 1 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 23 Jul 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 Portugal. 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 José Lopes, Master (+351913101958, up201410536@edu.fade.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory Blood Pressure Monitoring (time frame: Blood Pressure (in mmHg) will be assessed 15 minutes after the intervention and then every 20 minutes after each intervention session (exercise sessions and control session) until 12 hours after session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.