NCT06329804

Brief Summary

It is estimated by WHO (2021) that 1.4 billion individuals across the globe have high blood pressure with only 14% of people 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. Exercise is one possible strategy: in previous research, several different types of exercise have been shown to have effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of exercise (150 mins of moderate intensity exercise per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort / exertion and discomfort (Korkiakangas et al 2009). Thus, there is a need to investigate alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021). Low intensity isometric hand grip training (IHGT) has been shown to result in large decreases in rest-ing 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, IHGT has typically involved performing 4 x 2 IHGT holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). Interestingly, there are very few studies that have investigated the effect of changing different protocol parameters on the adaptations in blood pressure, and the minimal effective dose of IHGT is unknown. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IHGT will reduce the efficacy for improving blood pressure. Therefore, the aim of this randomised controlled trial is to compare the effect of IHGT with a frequency of 2 or 4 sessions/week on resting blood pressure.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

December 3, 2024

Status Verified

March 1, 2024

Enrollment Period

2.6 years

First QC Date

March 19, 2024

Last Update Submit

November 27, 2024

Conditions

Keywords

Blood PressureIsometric Handgrip ExerciseDose ResponseTraining FrequencyPerceptual Responses

Outcome Measures

Primary Outcomes (1)

  • Resting Systolic Blood Pressure

    Resting systolic blood pressure will be measured before training commences and then 3 days after the final exercise session.

    4 weeks

Secondary Outcomes (2)

  • Resting Diastolic Blood Pressure

    4 weeks

  • Resting Mean Arterial Blood Pressure

    4 weeks

Other Outcomes (2)

  • Ratings of perceived exertion

    4 Weeks (Week 1 and Week 4)

  • Affective Valence

    4 Weeks (Week 1 and Week 4)

Study Arms (3)

No Intervention Control

NO INTERVENTION

Participants allocated to this group will maintain their usual lifestyle for 4-weeks

Two Sessions/Week

EXPERIMENTAL

Participants allocated to this group will complete 4-weeks of isometric handgrip exercise training with a frequency of two sessions/week

Other: Isometric Handgrip Exercise Training (IHGT)

Four Sessions/Week

ACTIVE COMPARATOR

Participants allocated to this group will complete 4-weeks of isometric handgrip exercise training with a frequency of four sessions/week

Other: Isometric Handgrip Exercise Training (IHGT)

Interventions

Each IHGT session will consist of 4 x 2-minute contractions at 30% maximal voluntary contraction, with 2-minutes of rest in between, performed with the dominant hand. Training will be performed using an electronic hand dynamometer (Camry EH101, Zhongshan Camry Electronic Co. Ltd, Guangdong).

Four Sessions/WeekTwo Sessions/Week

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 40 years
  • Scoring 'low' on the international physical activity questionnaire (IPAQ)
  • Apparently healthy with no indications of chronic disease according to a self-report health history questionnaire and the physical activity readiness questionnaire.
  • Resting blood pressure \<140/90 mmHg during baseline assessment.

You may not qualify if:

  • Aged \<18 or \>40 years
  • Previously diagnosed with hypertension and/or currently taking anti-hypertensive medication.
  • Any contraindication to exercise based on responses to the self-report health-history questionnaire or the physical activity readiness questionnaire.
  • Scoring moderate or high on the international physical activity questionnaire (IPAQ).
  • Resting blood pressure \>140/90 mmHg during baseline assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan Normal University

Taipei, Taiwan

Location

Swansea University

Swansea, United Kingdom

Location

Study Officials

  • Richard Metcalfe, PhD

    Swansea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

November 1, 2021

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

December 3, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations