NCT06335433

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
19mo left

Started Mar 2024

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Mar 2024Mar 2028

Study Start

First participant enrolled

March 20, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

4 years

First QC Date

March 21, 2024

Last Update Submit

July 1, 2026

Conditions

Keywords

High Blood PressureIsometric Handgrip ExerciseVascular HealthTraining FrequencyDose ResponsePerceptual Responses

Outcome Measures

Primary Outcomes (1)

  • Office measured supine and seated systolic, diastolic and mean arterial pressure

    Office measured supine and seated systolic, diastolic and mean arterial pressure will be measured at baseline and 3 days following the final exercise session

    6 weeks

Secondary Outcomes (7)

  • Office measured central systolic, diastolic and mean arterial pressure

    6 weeks

  • 24-h mean ambulatory systolic, diastolic, and mean arterial pressure

    6 weeks

  • Daytime ambulatory systolic, diastolic, and mean arterial pressure

    6 weeks

  • Sleeping ambulatory systolic, diastolic and mean arterial pressure

    6 weeks

  • Carotid-Femoral Pulse Wave Velocity

    6 weeks

  • +2 more secondary outcomes

Study Arms (3)

No Intervention Control

NO INTERVENTION

Participants will be asked to maintain their normal lifestyle patterns (i.e. diet and physical activity) and will undergo no other intervention.

Two Sessions/Week

EXPERIMENTAL

Participants will complete 6-weeks of supervised isometric handgrip exercise training with a frequency of two sessions/week

Other: Exercise Training (Isometric Handgrip Exercise)

Four Sessions/Week

EXPERIMENTAL

Participants will complete 6-weeks of supervised isometric handgrip exercise training with a frequency of four sessions/week

Other: Exercise Training (Isometric Handgrip Exercise)

Interventions

Participants allocated to the exercise groups will complete 6 weeks of isometric handgrip exercise training (IHGT) using an electronic hand dynamometer (Camry EH101, Zhongshan Camry Electronic Co. Ltd, Guangdong) for either 2 or 4 sessions per week. Each exercise session will consist of 4 x 2-minute isometric contractions at 30% MVC with 1 minute rest periods between contractions. The first bout will be performed on the dominant arm and then the arm will be alternated for each subsequent two-minute bout. Participants will be instructed to try keep the contraction tension as close as possible to the set tension of 30% MVC using visual feedback from the dynamometer's electronic display.

Four Sessions/WeekTwo Sessions/Week

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swansea University

Swansea, Wales, SA18EN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Richard Metcalfe, PhD

    Swansea University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Metcalfe, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 28, 2024

Study Start

March 20, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

July 6, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations