Blood Pressure and Cardiac Autonomic Adaptations to Isometric Exercise Training

Sponsor

Canterbury Christ Church University (Other)

Overall Status

Completed

CT.gov ID

NCT05025202

Collaborator

(none)

Enrollment

Location

Arms

19.9

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Other: Isometric exercise training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Participants in the sham intervention group were not aware they they were not performing the IET intervention.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 15, 2019

Actual Primary Completion Date :

Dec 29, 2019

Actual Study Completion Date :

Sep 11, 2020

Arms and Interventions

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.

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

No Intervention: No intervention control

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Canterbury Christ Church University	Canterbury	Kent	United Kingdom

Sponsors and Collaborators

Canterbury Christ Church University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Canterbury Christ Church University

ClinicalTrials.gov Identifier:

NCT05025202

Other Study ID Numbers:

18/SAS/47C

First Posted:

Aug 27, 2021

Last Update Posted:

Sep 5, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Sep 5, 2021