Reduced Volume of Inspiratory Resistance Training (REVIRT)

University of Arizona

Status: Withdrawn

Conditions: Hypertension

Treatments: Behavioral: Inspiratory muscle strength training

Study type: Interventional

Funder types: Other

Identifiers

NCT05744817

00002581

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Inspiratory muscle strength training

IMST 3 days/week

Experimental group

Description:

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.

Treatment:

Behavioral: Inspiratory muscle strength training