Recruiting

Heart & BP

Sponsor:

Tracy Baynard

Code:

NCT06939153

Conditions

Orthostatic Intolerance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

LBNP

LBNP + Isometric handgrip exercise

Study Details

Brief summary:

As people get older, especially women, they often feel dizzy or even faint when they go from sitting or lying down to standing up. This happens because their blood pressure (BP) drops, which can lead to falls, heart problems, and even death in older adults. When BP changes, it affects how well the heart works and how it talks with blood vessels. However, little research has been done on how the heart and blood vessels talk during times of low BP. The crosstalk between the heart and blood vessels is important, as it allows enough blood and oxygen to reach the brain and other vital organs. Some research shows that as we get older, the crosstalk does not work as well. This can make it harder for blood to flow properly or put extra pressure on the heart and arteries. That's why we want to study how the heart and blood vessels talk during a laboratory-simulated situation of low BP in young and older men and women. In our study, participants will lie down with their lower body in a chamber that creates a vacuum around their legs. This safely mimics what happens when you stand up quickly. We can then measure heart function, the stress on arteries, and BP while your legs are in that vacuum. We'll use an ultrasound to check the heart and a finger cuff to measure BP. We'll also see if gripping something firmly can help protect from sudden drops in blood pressure. This study will help us understand more about a condition called orthostatic hypotension and might even suggest that handgrip exercise could prevent it.

The main questions the current study aims to address are:

  • Does the cross-talk between the heart and vessels become more impaired with aging during laboratory-simulated conditions of low BP?
  • Do women have worse crosstalk between the heart and blood vessels during laboratory-simulated conditions of BP?
  • Does hand gripping protect against drops in BP during conditions of low BP?

All participants will be asked to

  • Complete two laboratory conditions on two separate days with a randomized order (like flipping a coin):
  • Exposure to a lower body negative pressure (LBNP) chamber to safely simulate low BP (control)
  • Exposure to a lower body negative pressure (LBNP) while conducting hand-squeezingexercise (experimental).

The investigators will examine how heart and blood vessel interactions, as well as blood pressure (BP) responses, differ in young and older adults of both sexes when exposed to a laboratory-simulated low BP condition (LBNP), both with and without hand squeezing exercise.

Conditions

Orthostatic Intolerance

Study ID

NCT06939153

Start date

May 1, 2025

Status verified date

Apr, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria

  • People aged 18-35 years or aged ≥ 65 years
  • Healthy without symptons of orthostatic intolerance (i.e., nausea, sweating, weakness, visual disturbance)
  • Seated systolic and/or diastolic BP <140/90 mmHg;
  • Body mass index <35 kg/m2
  • Recreationally active (≤ 2 days of structured physical activity)
  • Regular menstrual cycles in young females

Exclusion Criteria:

  • People diagnosed with cardiovascular, diabetes, inflammatory or renal diseases and neurodegenerative-related dementia
  • Tobacco users
  • People prescribed with beta-blockers
  • Pregnant females
  • People unable to fit or get into the lower body negative pressure chamber

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Young male adults

All young males will complete both conditions under study: 1) LBNP and LBNP + isometric handgrip exercise

active comparator: Young females

All young females will complete both conditions under study: 1) LBNP and LBNP + isometric handgrip exercise

active comparator: Older male adults

All older males will complete both conditions under study: 1) LBNP and LBNP + isometric handgrip exercise

active comparator: Older female adults

All older females will complete both conditions under study: 1) LBNP and LBNP + isometric handgrip exercise

Interventions

LBNP

Participants will be exposed to a lower body negative pressure chamber protocol consisting of 5-min stages in the order of 20, -30, -40 and -50 mmHg.

LBNP + Isometric handgrip exercise

Participants will undergo 5-minute stages of LBNP at -20, -30, -40, and -50 mmHg in sequence. During the -30, -40, and -50 mmHg stages, they will perform a 2-minute isometric handgrip exercise, starting at the third minute and sustaining it for the remaining duration.

Primary outcome measure

  • Arterial elastance [ Time Frame: "Baseline/pre-LBNP", "During each LBNP stage (-20 mmHg, -30 mmHg, -40 mmHg, -50 mmHg) in the last 2 minutes" ]
  • Ventricular elastance [ Time Frame: "Baseline/pre-LBNP", "During each LBNP stage (-20 mmHg, -30 mmHg, -40 mmHg, -50 mmHg) in the last 2 minutes" ]
  • Ventricular-vascular coupling ratio [ Time Frame: "Baseline/pre-LBNP", "During each LBNP stage (-20 mmHg, -30 mmHg, -40 mmHg, -50 mmHg) in the last 2 minutes" ]
  • Wasted pressure effort [ Time Frame: "Baseline/pre-LBNP", "During each LBNP stage (-20 mmHg, -30 mmHg, -40 mmHg, -50 mmHg) in the last 2 minutes" ]
  • Brachial blood pressure [ Time Frame: "Baseline/pre-LBNP", "During each LBNP stage (-20 mmHg, -30 mmHg, -40 mmHg, -50 mmHg) in the last 2 minutes" ]

Central Contacts and Locations

Central contacts

Locations

University of Massachusetts Boston

Recruiting

Boston, Massachusetts, United States, 02125

Contacts

More Information

Sponsor

Tracy Baynard

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tracy Baynard on 2026-04-30.