Clinical trial NCT05744817: Reduced Volume of Inspiratory Resistance Training
Official title: Maintenance Dose of Inspiratory Muscle Strength Training to Preserve Cardiovascular Adaptations
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Keywords: vascular endothelium
blood pressure
inspiratory resistance training
non-pharmacological
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2023-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Cardiovascular disease (CVD) is the leading cause of death in the US and worldwide. Although it is well-known that lifestyle changes (e.g., diet, exercise) lower blood pressure (BP) and risk for cardiovascular events, an estimated \~98% of US adults with above-normal BP do not adhere to the recommended lifestyle behaviors. Common barriers to exercise, including lethargy, low exercise self-efficacy, fear of exercise-related pain, and lack of time, make adherence to traditional exercise strategies particularly difficult. The need for novel/different forms of exercise that are i) time-efficient, ii) well-tolerated, and iii) effective has never been greater.

Inspiratory muscle strength training (IMST) is a novel, time-efficient respiratory exercise, comprising just 5 sets of 6 inspiratory efforts with 1-minute rests between sets. This training takes just 5 mins/day, 5 sessions/wk, for a total weekly training time of 25-30 minutes. Distinct from other forms of traditional aerobic or high-intensity interval-type exercise, IMST is performed on a hand-held device in sitting or standing. Participants make repeated inspiratory efforts against a resistance and generate large negative pressures that are 2-4-fold greater than those generated during rest breathing, deep breathing, or high-intensity aerobic exercise. The investigators have shown that IMST performed 5 days/wk for 6 weeks, lowers SBP 9 ± 1 mmHg on average.

It is well known that exercise-induced adaptations plateau over time, despite increases in volume and/or intensity. Accordingly, the goal of exercise is not only to improve health, but to maintain health adaptations long term. Importantly, the dose of exercise required to improve health/performance is higher than the dose required to maintain health/performance. Given that lack of time is the most often cited reason for adults failing to initiate exercise and stopping chronic exercise participation, it is essential that any potential participant 1) appreciate the relationship between time spent exercising and health improvements and 2) understand how much exercise is needed to preserve exercise-induced adaptations to ensure an unnecessary amount of time is devoted to exercise. The investigators have shown that 6 weeks of IMST can significantly lower BP and improve respiratory strength, however, the dose needed to preserve these adaptations is unknown.

This study comprises a 6-week loading dose of IMST (5 days/week; Endpoint 1), followed by 12 weeks of IMST at a reduced dose (0, 1, or 3 days/week; Endpoint 2).

Eligibility criteria: Inclusion Criteria:

* 50+ 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline to endpoint 1 (6 weeks) resting systolic blood pressure
timeFrame: Blood pressure will be assessed at baseline and after 6 weeks of training
measure: Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks) resting systolic blood pressure
timeFrame: Blood pressure will be assessed after 6 weeks of training and after an additional 12 weeks of training
measure: Change from baseline to endpoint 1 (6 weeks) Nitric Oxide-mediated Endothelium Dependent Dilation (EDD)
timeFrame: EDD will be assessed at baseline and after 6 weeks of training
measure: Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks) Nitric Oxide-mediated Endothelium Dependent Dilation (EDD)
timeFrame: EDD will be assessed after 6 weeks of training and after an additional 12 weeks of training
Secondary outcomes:
measure: Change from baseline to endpoint 1 (6 weeks) cerebrovascular reactivity (CVR)
timeFrame: CVR will be assessed at baseline and after 6 weeks of training
measure: Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks)
timeFrame: CVR will be assessed after 6 weeks of training and after an additional 12 weeks of training
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Respiratory and Neurophysiology Laboratory
state: Arizona
Study officials:
affiliation: University of Arizona
name: Dallin Tavoian, PhD
role: PRINCIPAL_INVESTIGATOR
References: