Blood Pressure and Cardiac Autonomic Adaptations to Isometric Exercise Training

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Isometric exercise training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Canterbury, Kent, United Kingdom
      • Canterbury Christ Church University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IET; Participants allocated to this arm performed 4 weeks of isometric wall squat exercise training, 3 times per week.	Other: Isometric exercise training; 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.
SHAM_COMPARATOR: Sham; Participants allocated to this arm performed 4 weeks of isometric wall squat training, but the training prescription was intentionally provided at an insufficient intensity to achieve any physiology stimulus.	Other: Isometric exercise training; 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.
NO_INTERVENTION: No intervention control; Participants allocated to this arm did not perform any exercise and were required to maintain usual daily habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure (systolic, diastolic and mean BP)	Resting office blood pressure measured at brachial artery	At the start of the intervention (pre 4 week intervention)
Blood pressure (systolic, diastolic and mean BP)	Resting office blood pressure measured at brachial artery	At the end of the intervention (post 4 weeks)
Cardiac autonomics measured at HRV	LF and HF power spectral measures	At the start of the intervention (pre 4 week intervention)
Cardiac autonomics measured at HRV	LF and HF power spectral measures	At the end of the intervention (post 4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
continuous 5-minute blood pressure (systolic, diastolic and mean BP)	5 minute mean of resting blood pressure measured beat-to-beat	At the start of the intervention (pre 4 week intervention)
continuous 5-minute blood pressure (systolic, diastolic and mean BP)	5 minute mean of resting blood pressure measured beat-to-beat	At the end of the intervention (post 4 weeks)

Collaborators and Investigators

• Sponsor: Canterbury Christ Church University

Publications and helpful links

General Publications

• Decaux A, Edwards JJ, Swift HT, Hurst P, Hopkins J, Wiles JD, O'Driscoll JM. Blood pressure and cardiac autonomic adaptations to isometric exercise training: A randomized sham-controlled study. Physiol Rep. 2022 Jan;10(2):e15112. doi: 10.14814/phy2.15112.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2019
• Primary Completion (ACTUAL): December 29, 2019
• Study Completion (ACTUAL): September 11, 2020

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (ACTUAL): August 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 18/SAS/47C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No