Reduced Volume of Inspiratory Resistance Training

NCT ID: NCT05744817

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-13
• Study Completion Date: 2024-06-13

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).

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

IMST 1 day/week

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.

Group Type: EXPERIMENTAL

Inspiratory muscle strength training

Intervention Type: BEHAVIORAL

30 breaths/day against a set resistance

IMST 3 days/week

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.

Group Type: EXPERIMENTAL

Inspiratory muscle strength training

Intervention Type: BEHAVIORAL

30 breaths/day against a set resistance

Interventions

Inspiratory muscle strength training

30 breaths/day against a set resistance

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dallin Tavoian, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

Arizona Respiratory and Neurophysiology Laboratory

Tucson, Arizona, United States

Countries

United States

Other Identifiers

00002581

Identifier Type: -

Identifier Source: org_study_id