- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07251920
Isometric Resistance Training and Dose-dependent Effects in Pre- and Hypertensive Adults
Examination of the Dose-dependent Effects of Isometric Resistance Training on Decreases in Blood Pressure in Pre- and Hypertensive Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The World Health Organisation have reported hypertension, a major risk factor for cardiovascular disease (CVD), strokes and coronary heart disease (CHD), to be near epidemic levels globally with over 30% of the world's population, at this time, suffering from hypertension. Over the past twenty years isometric resistance training (IRT) has been established as one of the best forms of nonpharmacological interventions for the prevention and treatment of hypertension and endorsed by the American College of Cardiology / American Heart Association in their most recent guidelines. Thrice weekly IRT programmes undertaken (4 x 2-minute isometric contractions) at 20-30% of an individual's maximum voluntary contraction (MVC) for a period of 4-10 weeks have demonstrated reductions in clinic resting and ambulatory systolic blood pressure (-4 to -10 mmHg), in both normotensive and hypertensive men and women with no reported difference in the magnitude of these reductions between women and men.
Whilst isometric training has been shown to produce clinically meaningful reductions in blood pressure, utilising the commonly used protocol (4 x 2-min contractions) three-times a week, one of the main barriers to therapeutic exercise interventions is time to undertake the intervention and despite the observed benefits, adherence and compliance tends to be low. Indeed, regular exercise adherence declines over time, with only 50% of individuals continuing with regular exercise within the first twelve months following the completion of a therapeutic treatment, with a lack of perceived time cited as one of the main barriers. With this in mind, it is important to determine the effects of training dose on the changes in blood pressure seen following IRT. To date there is very little research into the effects of IRT dose on resting blood pressure with only one study purposely investigated the area. Whilst to the authors knowledge no studies have investigated the effects of altered training dose on ambulatory or diurnal blood pressure variations. Although three times a week has become the most commonly applied protocol there is no evidence to confirm that it is the most efficacious. As training dose is an important determinant of adaptations to exercise training, and with a lack of time cited as a perceived barrier to undertaking exercise, there is a need to determine the most efficacious training protocol to elicit clinical reductions in blood pressure, including shorter time saving (once or twice weekly) protocols.
Therefore, the study aims are to determine if a reduction in the weekly dose of isometric training, such as a reduction in the number of total contractions and therefore a reduced time commitment (once or twice weekly) would produce a similar hypotensive response to those reported.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Northamptonshire
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Northampton, Northamptonshire, United Kingdom, NN1 5PH
- University of Northampton, Waterside Campus
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- not taking anti-hypertensive medication
- borderlerine hypertensive or hypertensive (systolic blood pressure >139 mmHG, diastolic blood pressure > 89 mmHg
Exclusion Criteria:
- conditoned to resistance training
- currently taking anti-hypertensive medication
- regularly smoke or vape
- are pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Once-weekly training
Performed isometric resistance training once per week (four 2-minute contractions).
|
isometric resistance training was performed on the chest, arms, and leg muscle groups using a band.
Each contraction, was pulled at a perceived 30% (using a CR10 perceieved exertion rating scale) of maximum effort for 2 minutes; one repetition was performed using each muscle group.
Weekly frequnecy changed between groups, ranging from once to thrice per week.
|
|
Experimental: Twice-weekly training
Performed isometric resistance training twice per week (eight 2-minute contractions).
|
isometric resistance training was performed on the chest, arms, and leg muscle groups using a band.
Each contraction, was pulled at a perceived 30% (using a CR10 perceieved exertion rating scale) of maximum effort for 2 minutes; one repetition was performed using each muscle group.
Weekly frequnecy changed between groups, ranging from once to thrice per week.
|
|
Active Comparator: Thrice-weekly training
Performed isometric resistance training thrice per week (12 2-minute contractions).
|
isometric resistance training was performed on the chest, arms, and leg muscle groups using a band.
Each contraction, was pulled at a perceived 30% (using a CR10 perceieved exertion rating scale) of maximum effort for 2 minutes; one repetition was performed using each muscle group.
Weekly frequnecy changed between groups, ranging from once to thrice per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ambulatory blood pressure
Time Frame: Through study completion (12 weeks)
|
Blood pressure assessed during a 24-hour window
|
Through study completion (12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting blood pressure
Time Frame: Through study completion (12 weeks)
|
Blood pressure taken following a 10-minute rest period
|
Through study completion (12 weeks)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Zhou B, Perel P, Mensah GA, Ezzati M. Global epidemiology, health burden and effective interventions for elevated blood pressure and hypertension. Nat Rev Cardiol. 2021 Nov;18(11):785-802. doi: 10.1038/s41569-021-00559-8. Epub 2021 May 28.
- Smart NA, Way D, Carlson D, Millar P, McGowan C, Swaine I, Baross A, Howden R, Ritti-Dias R, Wiles J, Cornelissen V, Gordon B, Taylor R, Bleile B. Effects of isometric resistance training on resting blood pressure: individual participant data meta-analysis. J Hypertens. 2019 Oct;37(10):1927-1938. doi: 10.1097/HJH.0000000000002105.
- Lopes S, Felix G, Mesquita-Bastos J, Figueiredo D, Oliveira J, Ribeiro F. Determinants of exercise adherence and maintenance among patients with hypertension: a narrative review. Rev Cardiovasc Med. 2021 Dec 22;22(4):1271-1278. doi: 10.31083/j.rcm2204134.
- Garcia-Hermoso A, Lopez-Gil JF, Ramirez-Velez R, Alonso-Martinez AM, Izquierdo M, Ezzatvar Y. Adherence to aerobic and muscle-strengthening activities guidelines: a systematic review and meta-analysis of 3.3 million participants across 32 countries. Br J Sports Med. 2023 Feb;57(4):225-229. doi: 10.1136/bjsports-2022-106189. Epub 2022 Nov 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FREC2324002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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