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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05025202
Other study ID # 18/SAS/47C
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date September 11, 2020

Study information

Verified date August 2021
Source Canterbury Christ Church University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 11, 2020
Est. primary completion date December 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United Kingdom Canterbury Christ Church University Canterbury Kent

Sponsors (1)

Lead Sponsor Collaborator
Canterbury Christ Church University

Country where clinical trial is conducted

United Kingdom, 

Outcome

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