Sex Effects on Blood Pressure With Handgrip Training
1 other identifier
interventional
50
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
2 active sites
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
CompletedFirst Posted
Study publicly available on registry
January 22, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedMay 13, 2024
May 1, 2024
1.6 years
September 27, 2023
May 10, 2024
Conditions
Keywords
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
EXPERIMENTALParticipants will perform isometric handgrip training 3 days per week for a month.
Control
NO INTERVENTIONParticipants 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
Eligibility Criteria
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
University of Massachusetts Boston
Boston, Massachusetts, 02125, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Tracy Baynard, PhD
University of Massachusetts, Boston
Central Study Contacts
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