Reduced Volume of Inspiratory Resistance Training

NCT05744817 | Withdrawn

• 1 other identifier: 00002581
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical research study will investigate the dose of inspiratory muscle strength training needed to maintain cardiovascular adaptations induced by a six-week loading dose.

Conditions

Hypertension

Keywords

vascular endothelium; blood pressure; inspiratory resistance training; non-pharmacological

Outcome Measures

Primary Outcomes (4)

• Change from baseline to endpoint 1 (6 weeks) resting systolic blood pressure

  Systolic blood pressure (SBP) will be measured by absolute change from baseline. SBP will be assessed in accordance with American College of Cardiology/American Heart Association guidelines. Measurements will be taken using an automated oscillometric sphygmomanometer and will be performed in triplicate over the brachial artery of the left arm after 5 minutes of quiet rest, with 1 minute of recovery between measures. SBP will be defined as the average of the 3 pressures.

  Blood pressure will be assessed at baseline and after 6 weeks of training

• Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks) resting systolic blood pressure

  Systolic blood pressure (SBP) will be measured by absolute change from endpoint 1. SBP will be assessed as described in Outcome 1.

  Blood pressure will be assessed after 6 weeks of training and after an additional 12 weeks of training

• Change from baseline to endpoint 1 (6 weeks) Nitric Oxide-mediated Endothelium Dependent Dilation (EDD)

  Brachial artery Flow Mediated Dilation (BA-FMD), a well-established measure of NO-mediated endothelial function, will be measured by both relative and absolute changes from baseline. BA-FMD will be determined using high-resolution ultrasonography and analyzed with a commercially available software package. An ultrasound probe will be placed 3-6 cm proximal to the antecubital crease on the right arm and a baseline image of the right brachial artery will be obtained. Following baseline, reactive hyperemia will be produced by inflating a rapid-inflating blood pressure cuff. Brachial artery diameter change will be measured for 2 minutes following 5-min of forearm blood flow occlusion.

  EDD will be assessed at baseline and after 6 weeks of training

• Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks) Nitric Oxide-mediated Endothelium Dependent Dilation (EDD)

  EDD will be assessed as described in Outcome 3

  EDD will be assessed after 6 weeks of training and after an additional 12 weeks of training

Secondary Outcomes (2)

• Change from baseline to endpoint 1 (6 weeks) cerebrovascular reactivity (CVR)

  CVR will be assessed at baseline and after 6 weeks of training

• Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks)

  CVR will be assessed after 6 weeks of training and after an additional 12 weeks of training

Study Arms (3)

Control

NO INTERVENTION

30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, for 6 weeks, then no exercise for 12 weeks

IMST 1 day/week

EXPERIMENTAL

30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, for 6 weeks, then 30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 1 day/week, for 12 weeks.

Behavioral: Inspiratory muscle strength training

IMST 3 days/week

EXPERIMENTAL

30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, for 6 weeks, then 30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 3 days/week, for 12 weeks.

Behavioral: Inspiratory muscle strength training

Interventions

Inspiratory muscle strength training BEHAVIORAL

30 breaths/day against a set resistance

IMST 1 day/week; IMST 3 days/week

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age
• systolic blood pressure between 120-169 mmHg
• stable dose of medication (three months on the same dose)
• weight stable in the prior 3 months (\<3.0 kg weight change) and willing to remain weight stable throughout the study
• absence of unstable clinical disease as determined by medical history
• owns a smartphone

You may not qualify if:

• current smoker (including tobacco products, vaping devices, THC, etc…)
• have an uncontrolled medical condition (e.g., cancer)
• myocardial infarction or stroke within the previous 12 months
• performs regular aerobic exercise (\>4 bouts/week)
• BMI ≥ 40 kg/m2
• systolic blood pressure \<120 or ≥170 mmHg
• diastolic blood pressure \>100 or \<60 mmHg
• Cheyne-Stokes respiration
• history of perforated eardrum
• history of glaucoma or retinopathy
• history of collapsed lung
• diagnosed with asthma
• pregnant, breastfeeding, or trying to become pregnant (self-reported)
• medications that, in the opinion of the study physician, may impact the outcomes of the study (e.g., steroids)
• does not own a smartphone or is unwilling to download the required application

Sponsors & Collaborators

• University of Arizona: lead
• American Heart Association: collaborator

Study Sites (1)

Arizona Respiratory and Neurophysiology Laboratory

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dallin Tavoian, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the study groups, blinding is not possible.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will perform training 5 days/week for 6 weeks. Participants will then be randomly allocated at a 1:1:1 ratio to stop training (control), or to perform training 1 or 3 days/week for the next 12 weeks.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 27, 2023
• Study Start: June 13, 2024
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)