NCT05025202

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

August 16, 2021

Last Update Submit

August 31, 2021

Conditions

Hypertension

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

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

    At the start of the intervention (pre 4 week intervention)

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

    At the end of the intervention (post 4 weeks)

Study Arms (3)

IET

EXPERIMENTAL

Participants allocated to this arm performed 4 weeks of isometric wall squat exercise training, 3 times per week.

Other: Isometric exercise training

Sham

SHAM COMPARATOR

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

No intervention control

NO INTERVENTION

Participants allocated to this arm did not perform any exercise and were required to maintain usual daily habits.

Interventions

Isometric exercise trainingOTHER

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.

IETSham

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canterbury Christ Church University

Canterbury, Kent, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 35083878DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants in the sham intervention group were not aware they they were not performing the IET intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 27, 2021

Study Start

January 15, 2019

Primary Completion

December 29, 2019

Study Completion

September 11, 2020

Last Updated

September 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)