HypertensionBELIEF-BPNCT06937164
Blood Pressure Following Isometric Exercise in Inactive Adults
A study testing Isometric Exercise Training (IET) and Expectation-Enhancing Informational Framing in people with Hypertension and Elevated Blood Pressure, run by Canterbury Christ Church University at 1 site in United Kingdom.
Trial summary
This study investigates how isometric exercise training (IET) affects blood pressure in physically inactive adults. Isometric exercise involves sustained muscle contractions without movement-for example, pushing against a fixed object. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Elevated Blood Pressure, Sedentary Lifestlye
- What is being tested?
- Isometric Exercise Training (IET) and Expectation-Enhancing Informational Framing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Apr 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 years or older
- Self-reported physically inactive or insufficiently active (not meeting current physical activity guidelines)
- Not currently engaged in structured resistance or isometric exercise training
- Able to attend lab sessions over a 4-week period
- Provides written informed consent
Who cannot join
- Current diagnosis of hypertension requiring medication
- Any known cardiovascular, neurological, or musculoskeletal condition contraindicating isometric exercise
- Formal education or professional background in exercise science, physiology, or a related field
- Pregnant or planning to become pregnant during the study period
- Inability to follow verbal instructions or complete study protocols
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Canterbury Christ Church University
Canterbury, Kent, CT1 1QU
Sean Machak, +447864658805, s.machak@canterbury.ac.uk
About this study
Official title: Beliefs and Expectation Effects on Blood Pressure Following Isometric Exercise in Inactive Adults
This study investigates how isometric exercise training (IET) affects blood pressure in physically inactive adults. Isometric exercise involves sustained muscle contractions without movement-for example, pushing against a fixed object. Previous research has shown that IET may help reduce blood pressure, but the mechanisms involved are not fully understood.
The purpose of this study is to assess both the immediate (acute) and long-term (chronic) effects of IET on cardiovascular outcomes. Participants will complete a series of lab-based exercise sessions over several weeks. In these sessions, they will perform repeated bouts of isometric leg extensions while seated on an exercise machine designed to measure muscle force.
Read more
Throughout the study, researchers will monitor participants' blood pressure, heart rate, and muscle activity. Acute responses-such as post-exercise hypotension (a short-term drop in blood pressure)-will be measured immediately after exercise. Chronic changes, such as resting blood pressure improvements, will be evaluated across the training period.
Additional measurements will include heart rate variability (HRV), which gives insight into autonomic nervous system activity, and electromyography (EMG), which tracks muscle fatigue and activation patterns. These data will help explore potential mechanisms behind the cardiovascular benefits of IET.
By examining how repeated sessions of isometric exercise influence blood pressure and related physiological responses, this research may support the use of IET as a non-pharmacological strategy for managing or preventing hypertension in physically inactive individuals.
- Conditions
- Hypertension, Elevated Blood Pressure, Sedentary Lifestlye
- Being tested
- Isometric Exercise Training (IET), Expectation-Enhancing Informational Framing
- Keywords
- Isometric Exercise, Blood Pressure, Post-Exercise Hypotension, Physical Inactivity, Heart Rate Variability, Electromyography (EMG), Muscle Fatigue, Cardiovascular Adaptation, Exercise Intervention, Non-Pharmacological Treatment, Hypertension Prevention, Autonomic Nervous System, BELIEF-BP
- Medical subject headings
- Hypertension, Post-Exercise Hypotension, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Exercise Training (IET)Behavioural
Also called Static Strength Training, Leg Extension Hold Training
Participants perform four repetitions of 90 degree bilateral isometric leg extensions on a dynamometer at 30% of their maximum voluntary contraction (MVC). Each contraction is held for 2 minutes, with 2-minute rest intervals between bouts. Sessions are performed three times per week for four weeks. This behavioral intervention is designed to investigate the acute and chronic effects of isometric exercise on blood pressure, heart rate variability, and muscle fatigue.
Expectation-Enhancing Informational FramingBehavioural
Participants receive a brief standardized presentation highlighting isometric exercise as an evidence-based intervention for lowering blood pressure. The presentation includes statements designed to enhance outcome expectations based on prior literature and expert framing.
| Study group | Role | What they receive |
|---|---|---|
| Neutral Information + Isometric Exercise | Experimental | Participants in this group complete repeated isometric exercise training sessions. Prior to training, they receive a neutral informational presentation about isometric exercise, which does not mention blood pressure or cardiovascular benefits. The exercise consists of bilateral isometric leg extensions on a dynamometer. Cardiovascular and neuromuscular outcomes, including blood pressure, heart rate variability, and muscle fatigue, are monitored throughout the intervention period. Receives: Behavioral: Isometric Exercise Training (IET) |
| Expectation-Enhancing Info + Isometric Exercise | Experimental | Participants in this group complete repeated isometric exercise training sessions. Prior to training, they receive an expectation-enhancing informational presentation that emphasizes the effectiveness of isometric exercise as a non-pharmacological intervention for reducing blood pressure. The exercise consists of bilateral isometric leg extensions on a dynamometer. Blood pressure, heart rate variability, and muscle activity are assessed to determine physiological responses to the intervention. Receives: Behavioral: Isometric Exercise Training (IET); Behavioral: Expectation-Enhancing Informational Framing |
| No-Intervention Control | No intervention | Participants in this group do not receive any intervention or educational presentation. They attend study visits for assessment purposes only. Measurements include resting blood pressure, heart rate variability, and muscle activity, allowing for comparison with the intervention groups to evaluate the effects of isometric exercise training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Resting Systolic Blood Pressure
Systolic blood pressure will be measured at rest using a Task Force Monitor prior to and after the isometric exercise intervention period. The primary outcome is the change in resting systolic blood pressure from baseline to final testing. Measurements are taken in a seated position following standard resting protocols.
Measured: Baseline to Post-Intervention (approximately 4 weeks)
Secondary outcomes (4)
Change in Diastolic Blood Pressure
Diastolic blood pressure will be assessed in the same manner as systolic. The secondary outcome is the change in diastolic values from baseline to final testing.
Measured: Baseline to Post-Intervention (approximately 4 weeks)
Post-Exercise Hypotension Response
Post-exercise hypotension will be evaluated as the change in systolic and diastolic blood pressure immediately following each isometric exercise session, compared to pre-exercise baseline.
Measured: During the first week of the exercise intervention. Sessions 1, 2 and 3.
Change in Heart Rate Variability (HRV)
HRV will be analyzed using Task Force Monitor data to assess autonomic modulation. Measures include time-domain (e.g., RMSSD) and frequency-domain (e.g., LF/HF ratio) indices.
Measured: Baseline to Post-Intervention (approximately 4 weeks)
Change in Muscle Fatigue Markers (EMG)
Muscle fatigue will be assessed using surface electromyography (EMG) of the vastus lateralis. Fatigue indices include changes in median frequency and torque stability over repeated contractions.
Measured: Baseline to Post-Intervention (Approximately 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start21 Apr 2025
- Primary completion30 Aug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three parallel groups: (1) isometric exercise training (IET) with neutral information, (2) IET with expectation-enhancing information, or (3) a no-intervention control group. Intervention groups complete repeated isometric leg extension sessions across multiple visits. Prior to training, participants receive distinct information to influence their beliefs about IET. The control group does not receive training or information. Participants are blinded to group assignment, and outcomes such as blood pressure, heart rate variability, and muscle fatigue are assessed independently across groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Machak, Principal investigator, Canterbury Christ Church University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937164
- Sponsor's protocol ID
- ETH2223-0326
- Acronym
- BELIEF-BP
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an early-phase investigator-led study involving a small sample size. At this stage, there are no plans to share individual participant data due to ethical and data governance constraints outlined in the approved protocol. Aggregated results may be shared through publication or presentation.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beliefs and Expectation Effects on Blood Pressure Following Isometric Exercise in Inactive Adults
- ClinicalTrials.gov ID
- NCT06937164
- Acronym / sponsor ID
- BELIEF-BP / ETH2223-0326
- Conditions
- Hypertension, Elevated Blood Pressure, Sedentary Lifestlye
- Keywords
- Isometric Exercise, Blood Pressure, Post-Exercise Hypotension, Physical Inactivity, Heart Rate Variability, Electromyography (EMG), Muscle Fatigue, Cardiovascular Adaptation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 22 Apr 2025 (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.
This study investigates how isometric exercise training (IET) affects blood pressure in physically inactive adults. Isometric exercise involves sustained muscle contractions without movement-for example, pushing against a fixed object. Previous research has shown that IET may help reduce blood pressure, but the mechanisms involved are not fully understood.
The purpose of this study is to assess both the immediate (acute) and long-term (chronic) effects of IET on cardiovascular outcomes. Participants will complete a series of lab-based exercise sessions over several weeks. In these sessions, they will perform repeated bouts of isometric leg extensions while seated on an exercise machine designed to measure muscle force.
Throughout the study, researchers will monitor participants' blood pressure, heart rate, and muscle activity. Acute responses-such as post-exercise hypotension (a short-term drop in blood pressure)-will be measured immediately after exercise. Chronic changes, such as resting blood pressure improvements, will be evaluated across the training period.
Additional measurements will include heart rate variability (HRV), which gives insight into autonomic nervous system activity, and electromyography (EMG), which tracks muscle fatigue and activation patterns. These data will help explore potential mechanisms behind the cardiovascular benefits of IET.
By examining how repeated sessions of isometric exercise influence blood pressure and related physiological responses, this research may support the use of IET as a non-pharmacological strategy for managing or preventing hypertension in physically inactive individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three parallel groups: (1) isometric exercise training (IET) with neutral information, (2) IET with expectation-enhancing information, or (3) a no-intervention control group. Intervention groups complete repeated isometric leg extension sessions across multiple visits. Prior to training, participants receive distinct information to influence their beliefs about IET. The control group does not receive training or information. Participants are blinded to group assignment, and outcomes such as blood pressure, heart rate variability, and muscle fatigue are assessed independently across groups.
| Arm | Type | Receives |
|---|---|---|
| Neutral Information + Isometric Exercise | Experimental | Behavioral: Isometric Exercise Training (IET)Participants in this group complete repeated isometric exercise training sessions. Prior to training, they receive a neutral informational presentation about isometric exercise, which does not mention blood pressure or cardiovascular benefits. The exercise consists of bilateral isometric leg extensions on a dynamometer. Cardiovascular and neuromuscular outcomes, including blood pressure, heart rate variability, and muscle fatigue, are monitored throughout the intervention period. |
| Expectation-Enhancing Info + Isometric Exercise | Experimental | Behavioral: Isometric Exercise Training (IET), Behavioral: Expectation-Enhancing Informational FramingParticipants in this group complete repeated isometric exercise training sessions. Prior to training, they receive an expectation-enhancing informational presentation that emphasizes the effectiveness of isometric exercise as a non-pharmacological intervention for reducing blood pressure. The exercise consists of bilateral isometric leg extensions on a dynamometer. Blood pressure, heart rate variability, and muscle activity are assessed to determine physiological responses to the intervention. |
| No-Intervention Control | No intervention | –Participants in this group do not receive any intervention or educational presentation. They attend study visits for assessment purposes only. Measurements include resting blood pressure, heart rate variability, and muscle activity, allowing for comparison with the intervention groups to evaluate the effects of isometric exercise training. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Self-reported physically inactive or insufficiently active (not meeting current physical activity guidelines)
- Not currently engaged in structured resistance or isometric exercise training
- Able to attend lab sessions over a 4-week period
- Provides written informed consent
Key exclusion criteria (5 listed)
- Current diagnosis of hypertension requiring medication
- Any known cardiovascular, neurological, or musculoskeletal condition contraindicating isometric exercise
- Formal education or professional background in exercise science, physiology, or a related field
- Pregnant or planning to become pregnant during the study period
- Inability to follow verbal instructions or complete study protocols
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 Exercise Training (IET)Also: Static Strength Training, Leg Extension Hold TrainingParticipants perform four repetitions of 90 degree bilateral isometric leg extensions on a dynamometer at 30% of their maximum voluntary contraction (MVC). Each contraction is held for 2 minutes, with 2-minute rest intervals between bouts. Sessions are performed three times per week for four weeks. This behavioral intervention is designed to investigate the acute and chronic effects of isometric exercise on blood pressure, heart rate variability, and muscle fatigue. | Behavioural | Expectation-Enhancing Info + Isometric Exercise, Neutral Information + Isometric Exercise |
| Expectation-Enhancing Informational FramingParticipants receive a brief standardized presentation highlighting isometric exercise as an evidence-based intervention for lowering blood pressure. The presentation includes statements designed to enhance outcome expectations based on prior literature and expert framing. | Behavioural | Expectation-Enhancing Info + Isometric Exercise |
Primary outcome
Change in Resting Systolic Blood Pressure
Time frame: Baseline to Post-Intervention (approximately 4 weeks)
Systolic blood pressure will be measured at rest using a Task Force Monitor prior to and after the isometric exercise intervention period. The primary outcome is the change in resting systolic blood pressure from baseline to final testing. Measurements are taken in a seated position following standard resting protocols.
4 secondary outcomes
Change in Diastolic Blood Pressure
Time frame: Baseline to Post-Intervention (approximately 4 weeks)
Post-Exercise Hypotension Response
Time frame: During the first week of the exercise intervention. Sessions 1, 2 and 3.
Change in Heart Rate Variability (HRV)
Time frame: Baseline to Post-Intervention (approximately 4 weeks)
Change in Muscle Fatigue Markers (EMG)
Time frame: Baseline to Post-Intervention (Approximately 4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No. This is an early-phase investigator-led study involving a small sample size. At this stage, there are no plans to share individual participant data due to ethical and data governance constraints outlined in the approved protocol. Aggregated results may be shared through publication or presentation.
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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.
Sean Machak principal investigator
Canterbury Christ Church University
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 Training (IET) and Expectation-Enhancing Informational Framing in people with Hypertension and Elevated Blood Pressure, run by Canterbury Christ Church University at 1 site in United Kingdom.
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 5 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: looking for participants now, as of the sponsor's last update on 16 May 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean Machak (+447864658805, s.machak2125@canterbury.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resting Systolic Blood Pressure (time frame: Baseline to Post-Intervention (approximately 4 weeks)). 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 16 May 2025.