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Completed

NCT Number: NCT05025202

Blood Pressure and Cardiac Autonomic Adaptations to Isometric Exercise Training

A randomized, sham-controlled intervention measuring the effects of isometric exercise training (IET) on blood pressure and cardiac autonomics.

IET has been proven effective in a plethora of randomized trials, but very little research has employed a sham-controlled design. This researched involved the recruitment of 30 participants who completed a 4 week IET intervention, sham control of the IET intervention, or a non-intervention control period. Pre and post blood pressure and cardiac autonomic measures were acquired and analysed.

The hypothesis of this trial was a significant effect of IET on blood pressure, with no such effects following the sham control or normal control interventions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canterbury Christ Church University

Canterbury, Kent, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy with no significant health conditions contraindicating exercise
  • Over 18 years of age
  • Physically inactive

Exclusion criteria

  • Achieving current physical activity guidelines
  • Abnormal resting ECG
  • under 18

Treatment and study plan

Isometric exercise training

Other

A form of exercise involving static contraction against a wall, sustained for 2 minutes x4 sets per session. 3 sessions a week were required. The intensity was designed to achieve 95% of the participants maximum heart rate.

Primary outcomes

  1. Blood pressure (systolic, diastolic and mean BP)

    Time frame: At the start of the intervention (pre 4 week intervention)

    Resting office blood pressure measured at brachial artery

  2. Blood pressure (systolic, diastolic and mean BP)

    Time frame: At the end of the intervention (post 4 weeks)

    Resting office blood pressure measured at brachial artery

  3. Cardiac autonomics measured at HRV

    Time frame: At the start of the intervention (pre 4 week intervention)

    LF and HF power spectral measures

  4. Cardiac autonomics measured at HRV

    Time frame: At the end of the intervention (post 4 weeks)

    LF and HF power spectral measures

Secondary outcomes

  1. continuous 5-minute blood pressure (systolic, diastolic and mean BP)

    Time frame: At the start of the intervention (pre 4 week intervention)

    5 minute mean of resting blood pressure measured beat-to-beat

  2. continuous 5-minute blood pressure (systolic, diastolic and mean BP)

    Time frame: At the end of the intervention (post 4 weeks)

    5 minute mean of resting blood pressure measured beat-to-beat

Sponsors and collaborators

Lead sponsor

Canterbury Christ Church University

Other

Registry information

Official study title

Blood Pressure and Cardiac Autonomic Adaptations to Isometric Exercise Training: a Randomised Sham-controlled Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 27, 2021
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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