- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06937164
Blood Pressure Following Isometric Exercise in Inactive Adults (BELIEF-BP)
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.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sean Machak
- Phone Number: +447864658805
- Email: s.machak2125@canterbury.ac.uk
Study Contact Backup
- Name: Philip Hurst
- Phone Number: 1466 +44 (0)1227 927700
- Email: philip.hurst@canterbury.ac.uk
Study Locations
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-
Kent
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Canterbury, Kent, United Kingdom, CT1 1QU
- Recruiting
- Canterbury Christ Church University
-
Contact:
- Sean Machak
- Phone Number: +447864658805
- Email: s.machak@canterbury.ac.uk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neutral Information + Isometric Exercise
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.
|
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.
Other Names:
|
|
Experimental: Expectation-Enhancing Info + Isometric Exercise
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.
|
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.
Other Names:
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.
|
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No Intervention: No-Intervention Control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline to Post-Intervention (approximately 4 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Diastolic Blood Pressure
Time Frame: Baseline to Post-Intervention (approximately 4 weeks)
|
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.
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Baseline to Post-Intervention (approximately 4 weeks)
|
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Post-Exercise Hypotension Response
Time Frame: During the first week of the exercise intervention. Sessions 1, 2 and 3.
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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.
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During the first week of the exercise intervention. Sessions 1, 2 and 3.
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Change in Heart Rate Variability (HRV)
Time Frame: Baseline to Post-Intervention (approximately 4 weeks)
|
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.
|
Baseline to Post-Intervention (approximately 4 weeks)
|
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Change in Muscle Fatigue Markers (EMG)
Time Frame: Baseline to Post-Intervention (Approximately 4 weeks)
|
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.
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Baseline to Post-Intervention (Approximately 4 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Sean Machak, Canterbury Christ Church University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETH2223-0326
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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