NCT06937164

Brief 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. 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.

Trial Health

57
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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 below P25 for not_applicable hypertension

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 7, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

April 21, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

May 16, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

April 7, 2025

Last Update Submit

May 15, 2025

Conditions

Keywords

Isometric ExerciseBlood PressurePost-Exercise HypotensionPhysical InactivityHeart Rate VariabilityElectromyography (EMG)Muscle FatigueCardiovascular AdaptationExercise InterventionNon-Pharmacological TreatmentHypertension PreventionAutonomic Nervous SystemBELIEF-BP

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to Post-Intervention (approximately 4 weeks)

Secondary Outcomes (4)

  • Change in Diastolic Blood Pressure

    Baseline to Post-Intervention (approximately 4 weeks)

  • Post-Exercise Hypotension Response

    During the first week of the exercise intervention. Sessions 1, 2 and 3.

  • Change in Heart Rate Variability (HRV)

    Baseline to Post-Intervention (approximately 4 weeks)

  • Change in Muscle Fatigue Markers (EMG)

    Baseline to Post-Intervention (Approximately 4 weeks)

Study Arms (3)

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.

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.

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.

Interventions

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.

Also known as: Static Strength Training, Leg Extension Hold Training
Expectation-Enhancing Info + Isometric ExerciseNeutral Information + Isometric Exercise

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.

Expectation-Enhancing Info + Isometric Exercise

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canterbury Christ Church University

Canterbury, Kent, CT1 1QU, United Kingdom

RECRUITING

MeSH Terms

Conditions

HypertensionPost-Exercise HypotensionSedentary Behavior

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOrthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionBehavior

Study Officials

  • Sean Machak

    Canterbury Christ Church University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are blinded to group assignment. They are not informed whether they are receiving neutral or expectation-enhancing information, or whether they are in a control group. Due to the nature of the study, the researcher is not blinded.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 22, 2025

Study Start

April 21, 2025

Primary Completion

August 30, 2025

Study Completion

September 1, 2025

Last Updated

May 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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.

Locations