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Recruiting NCT06335433

NCT06335433 Isometric Handgrip Training Frequency and Blood Pressure in People With Hypertension

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Clinical Trial Summary
NCT ID NCT06335433
Status Recruiting
Phase
Sponsor Swansea University
Condition Hypertension
Study Type INTERVENTIONAL
Enrollment 45 participants
Start Date 2024-03-20
Primary Completion 2028-03

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
Exercise Training (Isometric Handgrip Exercise)

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 45 participants in total. It began in 2024-03-20 with a primary completion date of 2028-03.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Hypertension is the most important cause of cardiovascular disease (CVD), stroke, and premature death (WHO, 2021). It is estimated by The World Health Organisation in 2021 that 1.4 billion individuals across the globe have high blood pressure, with only 14% of people actively managing these elevated levels. Simple and effective lifestyle strategies are required to help people improve their blood pressure and/or attenuate increases in blood pressure with ageing. Physical activity is one possible strategy: in previous research, several different types of physical activity have been shown to have beneficial effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of physical activity (150 mins of moderate intensity physical activity per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort, exertion, and physical discomfort (Korkiakangas et al 2009). Thus, there is a need to identify alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021, Toohey et al, 2018). Low intensity isometric hand grip exercise training (IET) has been shown to result in large decreases in resting blood pressure in younger and older age groups, in both men and women, and in individuals with normal as well as elevated baseline blood pressure (Badrov et al, 2013; Bentley et al., 2018; Millar et al., 2014). In this research, IET has almost universally involved performing 4 x 2 IET holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). There are very few studies that have investigated the effect of changing different protocol parameters on changes in blood pressure and vascular health, and the minimal effective dose of IET is unknown. Defining the minimal effective dose of different types of exercise may help overcome key barriers to exercise by lowering the required time commitment, reducing perceived effort/exertion, and promoting more positive affective responses. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IET will reduce the efficacy for improving blood pressure. Therefore, the primary objective of this study is to determine if reducing the frequency of isometric handgrip training from four times a week to two times a week will affect the improvements in resting blood pressure and vascular health in people with hypertension. A secondary objective is to investigate the acute affective and perceptual responses to sessions of IET and the effect of training on these acute affective/perceptual responses.

Eligibility Criteria

Inclusion Criteria: * Aged between 18 and 65 years. * Scoring low or moderate on the international physical activity questionnaire (IPAQ). * Previous diagnosis of high blood pressure and/or a resting systolic blood pressure ≥130 but \<180 mmHg (self-reported and confirmed during screening/baseline assessment). * Currently taking no anti-hypertensive medicine or taking anti-hypertensive medicine with no treatment change within the last 4 months prior to enrollment. * Stable dietary and physical activity patterns (including dietary supplementation) over the last 4 months Exclusion Criteria: * Aged \<18 or \>65 years * Resting blood pressure ≥180/110 mmHg or resting heart rate \>100 bpm during baseline as-sessment * Manifest cardiovascular disease including cerebrovascular disease, heart failure, chronic kidney disease, peripheral vascular disease, or advanced retinopathy (fundus hypertonicus grades III-IV) based on a self-report health history questionnaire. * Type 1 diabetes * History of other chronic disease including malignancy, neurological conditions (e.g. multiple sclerosis) or respiratory conditions (e.g. COPD). * Contraindications to exercise based on answers to the physical activity readiness questionnaire. * Physical limitations preventing handgrip exercise (e.g. arthritis or other musculoskeletal disorder) * Scoring "high" on the international physical activity questionnaire * Taking more than 2 anti-hypertensive drugs or a change in treatment strategy in the previous 4 months. * Currently taking nitrate medication (as it is commonly prescribed for angina) or on hormone replacement therapy * Significant self-reported change in lifestyle patterns in the prior 4 months (e.g. currently on a planned diet for weight loss).

Contact & Investigator

Central Contact

Richard Metcalfe, PhD

✉ r.s.metcalfe@swansea.ac.uk

📞 01792205678

Principal Investigator

Richard Metcalfe, PhD

PRINCIPAL INVESTIGATOR

Swansea University

Frequently Asked Questions

Who can join the NCT06335433 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06335433 currently recruiting?

Yes, NCT06335433 is actively recruiting participants. Contact the research team at r.s.metcalfe@swansea.ac.uk for enrollment information.

Where is the NCT06335433 trial being conducted?

This trial is being conducted at Swansea, United Kingdom.

Who is sponsoring the NCT06335433 clinical trial?

NCT06335433 is sponsored by Swansea University. The principal investigator is Richard Metcalfe, PhD at Swansea University. The trial plans to enroll 45 participants.

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