HypertensionNCT05025202
Blood Pressure and Cardiac Autonomic Adaptations to Isometric Exercise Training
A study testing Isometric exercise training in people with Hypertension, run by Canterbury Christ Church University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Isometric exercise training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2019to 11 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy with no significant health conditions contraindicating exercise
- Over 18 years of age
- Physically inactive
Who cannot join
- Achieving current physical activity guidelines
- Abnormal resting ECG
- under 18
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Canterbury Christ Church University
Canterbury, Kent
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Isometric exercise training
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| IET | Experimental | Participants allocated to this arm performed 4 weeks of isometric wall squat exercise training, 3 times per week. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (systolic, diastolic and mean BP)
Resting office blood pressure measured at brachial artery
Measured: 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
Measured: At the end of the intervention (post 4 weeks)
Cardiac autonomics measured at HRV
LF and HF power spectral measures
Measured: At the start of the intervention (pre 4 week intervention)
Cardiac autonomics measured at HRV
LF and HF power spectral measures
Measured: At the end of the intervention (post 4 weeks)
Secondary outcomes (2)
continuous 5-minute blood pressure (systolic, diastolic and mean BP)
5 minute mean of resting blood pressure measured beat-to-beat
Measured: 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
Measured: At the end of the intervention (post 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start15 Jan 2019
- Primary completion29 Dec 2019
- Study completion11 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025202
- Sponsor's protocol ID
- 18/SAS/47C
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35083878
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure and Cardiac Autonomic Adaptations to Isometric Exercise Training: a Randomised Sham-controlled Study
- ClinicalTrials.gov ID
- NCT05025202
- Acronym / sponsor ID
- 18/SAS/47C
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 29 Dec 2019 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IET | Experimental | Other: Isometric exercise trainingParticipants allocated to this arm performed 4 weeks of isometric wall squat exercise training, 3 times per week. |
| Sham | Sham comparator | Other: Isometric exercise trainingParticipants 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. |
| No intervention control | No intervention | –Participants allocated to this arm did not perform any exercise and were required to maintain usual daily habits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy with no significant health conditions contraindicating exercise
- Over 18 years of age
- Physically inactive
Key exclusion criteria (3 listed)
- Achieving current physical activity guidelines
- Abnormal resting ECG
- under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric exercise trainingA 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. | Other | IET, Sham |
Primary outcome
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
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
Cardiac autonomics measured at HRV
Time frame: At the start of the intervention (pre 4 week intervention)
LF and HF power spectral measures
Cardiac autonomics measured at HRV
Time frame: At the end of the intervention (post 4 weeks)
LF and HF power spectral measures
2 secondary outcomes
continuous 5-minute blood pressure (systolic, diastolic and mean BP)
Time frame: At the start of the intervention (pre 4 week intervention)
continuous 5-minute blood pressure (systolic, diastolic and mean BP)
Time frame: At the end of the intervention (post 4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Derived from this study: PubMed 35083878Decaux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercise training in people with Hypertension, run by Canterbury Christ Church University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (systolic, diastolic and mean BP) (time frame: At the start of the intervention (pre 4 week intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05025202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.