- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06215014
Sex Effects on Blood Pressure With Handgrip Training
Sex Effects on Blood Pressure Regulation to Acute Isometric Handgrip Exercise, Following 4 Weeks of Isometric Handgrip Training
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypertension is still the leading modifiable risk factor for cardiovascular disease and a silent independent predictor of all-cause death worldwide. Projections for the US suggest that 41% of adults will develop hypertension before 2030. Thus, it is clinically relevant to optimize interventions aimed at preventing and managing hypertension.
Isometric handgrip training holds promise to mitigate the growing prevalence of hypertension in healthy adults. This form of exercise training can be performed at home, requires less time investment compared to conventional training, and requires only one piece of inexpensive equipment. Interestingly, some but not all studies suggest that isometric handgrip training yields superior antihypertensive effects in young healthy males compared to their female counterparts. The mechanisms behind the antihypertensive effects of isometric handgrip training are yet to be determined. Possible candidates include: 1) increases in cardiovagal modulation and 2) increases in endothelial nitric oxide-dependent vasodilation coupled with reductions in arterial stiffness.
The understanding of blood pressure (BP) regulation to acute isometric handgrip exercise would provide valuable mechanistic insight into possible sex-dependent antihypertensive effects of this form of training, given that acute responses likely translate into antihypertensive training adaptations. In fact, in healthy young adults, an acute bout of isometric handgrip exercise has been shown to evoke a higher blood pressure response in males compared to females immediately after exercise cessation. Given that higher hypertensive responses to acute isometric handgrip exercise are associated with greater reductions in resting BP following isometric handgrip training, this could explain the larger antihypertensive effects reported in young males. Importantly, young females are generally less fatigable to isometric handgrip exercise performed at the same relative intensity than males. This sex difference in muscle fatigability relates to the larger muscle mass and strength of males leading to higher intramuscular pressures that compress feeding arteries but also to the smaller increments in blood pressure of females to exercise. Importantly, whether this sex difference in fatigability and blood pressure during acute isometric handgrip exercise limits the potential for blood pressure-related adaptations to handgrip training in females is unknown. In addition, young females also exhibit a faster BP recovery to acute isometric handgrip exercise than their male counterparts. Mechanistically, this faster recovery is, in part, attributed to faster cardiovagal reactivation and higher increases in baroreflex sensitivity observed in females but not in males. However, whether other regulatory mechanisms, such as increases in endothelial nitric oxide-mediated vasodilation and or reductions in sympathetic outflow to blood vessels contribute to this apparently faster blood pressure recovery in females after a hypertensive stimulus is unknown. In addition, blood flow and baroreflex dynamics interplay during isometric handgrip exercise are largely unknown which might provide valuable insight into blood pressure regulation after exercise cessation.
Therefore, the specific aims of this study are threefold:
Aim 1 - To examine if the effects of a 4-week isometric handgrip training intervention on BP regulation to a fatiguing bout of isometric handgrip exercise are sex- dependent in young healthy adults with normal BP
Aim 2 - To examine if blood pressure responses are sex-dependent during and after a fatiguing bout of isometric handgrip exercise at 30% maximum voluntary contraction in healthy young adults with normal blood pressure;
Aim 3 - To determine the effects of sex on the regulatory mechanisms of blood pressure, including cardiac autonomic and vascular function during and after a fatiguing bout of isometric handgrip exercise in healthy young adults with normal BP.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: João L. Marôco, MS
- Phone Number: 773-893-3897
- Email: joao.maroco001@umb.edu
Study Contact Backup
- Name: Tracy Baynard, PhD
- Phone Number: 2178404493
- Email: tracy.baynard@umb.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02125
- Recruiting
- UMassachusetts Boston
-
Contact:
- Tracy Baynard, PhD
- Phone Number: 217-840-4493
- Email: tracy.baynard@umb.edu
-
Boston, Massachusetts, United States, 02125
- Not yet recruiting
- University of Massachusetts Boston
-
Contact:
- Tracy Baynard, PhD
- Phone Number: 217-840-4493
- Email: tracy.baynard@umb.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Handgrip training
Participants will perform isometric handgrip training 3 days per week for a month.
|
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
|
No Intervention: Control
Participants will not perform isometric handgrip training for a month.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brachial blood pressure
Time Frame: "Baseline, pre-intervention/oscillometry", "Within 5-days after the intervention/oscillometry"
|
Systolic and diastolic blood pressure
|
"Baseline, pre-intervention/oscillometry", "Within 5-days after the intervention/oscillometry"
|
Flow-mediated dilation
Time Frame: "Baseline, pre-intervention/ultrasonography", "Within 5-days after the intervention/ultrasonography"
|
Non-invasive measurement of endothelial function
|
"Baseline, pre-intervention/ultrasonography", "Within 5-days after the intervention/ultrasonography"
|
Root mean square of successive differences (RMSSD)
Time Frame: "Baseline, pre-intervention/electrocardiography", "Within 5-days after the intervention/electrocardiography"
|
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
Time Frame: "Baseline, pre-intervention/electrocardiography", "Within 5-days after the intervention/electrocardiography"
|
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)
Time Frame: "Baseline, pre-intervention/ultrasonography", "Within 5-days after the intervention/applanation tonometry"
|
Central arterial stiffness
|
"Baseline, pre-intervention/ultrasonography", "Within 5-days after the intervention/applanation tonometry"
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tracy Baynard, PhD, University of Massachusetts, Boston
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 3471
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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