NCT06215014

Brief Summary

The goal of this intervention is to compare the blood pressure response of young females and males to a single bout of static handgrip exercise before and after static handgrip training (4 weeks). The main questions this study aims to answer are:

  • Are the lowering blood pressure effects of static handgrip exercise training different between young females and males?
  • Which factors explain the lowering blood pressure effects of static handgrip training and possible differences between sexes? Is it an improved blood vessel dilation? Is it a reduced stiffening of blood vessels? Is it a reduced fight or flight response resulting in a lower heart rate and blood pumped by the heart into the vessels? All the above?
  • Which factors regulate blood pressure response during and immediately after a single bout of static handgrip exercise? All participants will be asked to:
  • Visit the laboratory to perform static handgrip exercise - first visit;
  • Participants will be randomized (like flipping a coin) to static handgrip exercise training or to a non-exercising phase, with each phase lasting four weeks. Participants will also complete the other condition (handgrip or no handgrip) after completing the first four-week condition
  • Return to the laboratory after the completion of both static handgrip training and no training to perform the static handgrip exercise of the first visit. The investigators will compare participants' blood pressure response to a single bout static of handgrip exercise after training to their own blood pressure response to the same bout of exercise after the non-training period.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

September 27, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

1.6 years

First QC Date

September 27, 2023

Last Update Submit

May 10, 2024

Conditions

Keywords

exercise traininghandgripsex effects

Outcome Measures

Primary Outcomes (5)

  • Brachial blood pressure

    Systolic and diastolic blood pressure

    "Baseline, pre-intervention/oscillometry", "Within 5-days after the intervention/oscillometry"

  • Flow-mediated dilation

    Non-invasive measurement of endothelial function

    "Baseline, pre-intervention/ultrasonography", "Within 5-days after the intervention/ultrasonography"

  • Root mean square of successive differences (RMSSD)

    Heart rate variability metric of the time domain reflecting cardiovagal modulation

    "Baseline, pre-intervention/electrocardiography", "Within 5-days after the intervention/electrocardiography"

  • High frequency power band

    Heart rate variability metric of the spectral domain reflecting cardiovagal modulation

    "Baseline, pre-intervention/electrocardiography", "Within 5-days after the intervention/electrocardiography"

  • Carotid femoral pulse wave velocity (cfPWV)

    Central arterial stiffness

    "Baseline, pre-intervention/ultrasonography", "Within 5-days after the intervention/applanation tonometry"

Study Arms (2)

Handgrip training

EXPERIMENTAL

Participants will perform isometric handgrip training 3 days per week for a month.

Other: Isometric handgrip training

Control

NO INTERVENTION

Participants will not perform isometric handgrip training for a month.

Interventions

Participants will train three days per week at home for 1 month using a reliable and validated digital handgrip dynamometer (DynX, MD System, Inc., Westerville, USA) in a seated position. The isometric handgrip training protocol will consist of four sets (2 for each hand) of two-min sustained contractions starting at 30% of maximum voluntary contraction (MVC) interspersed by 1-min resting periods (a total of 12-min). All training sessions will be remotely supervised via Zoom or phone call by a research team member to ensure compliance with the exercise prescription. Before each training session, MVCs will be re-assessed over three repetitions, each separated by 30-s, to ensure an accurate exercise prescription. The highest value will be used to determine the target intensity of the session

Handgrip training

Eligibility Criteria

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

You may qualify if:

  • Ages between 18-40 years;
  • Normal blood pressure as defined by the American Heart Association (\<130/90 mmHg);
  • BMI \< 30 kg/m2;
  • No cardiovascular risk factors and no clinically diagnosed cardiovascular disease;
  • Being recreationally active (≤ 2 days of structured physical activity);
  • Able to speak English.

You may not qualify if:

  • Diagnosed with cardiovascular disease (e.g., coronary artery disease, heart failure), musculoskeletal (i.e., osteoporosis and sarcopenia), metabolic disease (e.g., diabetes mellitus) and kidney disease;
  • Taking antihypertensive or other vasoactive medications and cardioactive medication;
  • Diagnosed with depression and/or anxiety disorders;
  • Long COVID;
  • Being a smoker;
  • Being pregnant or having menstrual irregularities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UMassachusetts Boston

Boston, Massachusetts, 02125, United States

RECRUITING

University of Massachusetts Boston

Boston, Massachusetts, 02125, United States

NOT YET RECRUITING

Study Officials

  • Tracy Baynard, PhD

    University of Massachusetts, Boston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

João L. Marôco, MS

CONTACT

Tracy Baynard, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Assoc Vice Provost, Grad Edu

Study Record Dates

First Submitted

September 27, 2023

First Posted

January 22, 2024

Study Start

March 1, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations