HypertensionREVIRTNCT05744817
Reduced Volume of Inspiratory Resistance Training
A study testing Inspiratory muscle strength training in people with Hypertension, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Inspiratory muscle strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2024to 13 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Arizona Respiratory and Neurophysiology Laboratory
Tucson, Arizona, 85724
About this study
Official title: Maintenance Dose of Inspiratory Muscle Strength Training to Preserve Cardiovascular Adaptations
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.
Read the 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
- Being tested
- Inspiratory muscle strength training
- Keywords
- vascular endothelium, blood pressure, inspiratory resistance training, non-pharmacological
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle strength trainingBehavioural
30 breaths/day against a set resistance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Inspiratory muscle strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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 via changes in middle cerebral artery (MCA) blood velocitywill be assessed in a reclined sitting position while breathing room air and again after 4 min of breathing a medical gas mixture with 5 % CO2 l to elicit vasodilation. A transcranial Doppler probe will be placed over the subject's temple to obtain a velocity tracing from the middle cerebral artery. After a tracing of MCA velocity is obtained and baseline measurements are recorded (while breathing room air), the subject will then switch over to breathing 5% CO2 for
Measured: 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 as described in Outcome 5
Measured: CVR will be assessed after 6 weeks of training and after an additional 12 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start13 Jun 2024 (estimated)
- Primary completion13 Jun 2024 (estimated)
- Study completion13 Jun 2024
Why it stopped: Resource availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Dallin Tavoian, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744817
- Sponsor's protocol ID
- 00002581
- Acronym
- REVIRT
- Status last verified
- Jun 2024
- First submitted
- 15 Feb 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Dose of Inspiratory Muscle Strength Training to Preserve Cardiovascular Adaptations
- ClinicalTrials.gov ID
- NCT05744817
- Acronym / sponsor ID
- REVIRT / 00002581
- Conditions
- Hypertension
- Keywords
- vascular endothelium, blood pressure, inspiratory resistance training, non-pharmacological
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Resource availability
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 13 Jun 2024 (estimated)
- Primary completion
- 13 Jun 2024 (estimated)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Inspiratory muscle strength training30 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. |
| IMST 3 days/week | Experimental | Behavioral: Inspiratory muscle strength training30 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle strength training30 breaths/day against a set resistance | Behavioural | IMST 1 day/week, IMST 3 days/week |
Primary outcome
Change from baseline to endpoint 1 (6 weeks) resting systolic blood pressure
Time frame: Blood pressure will be assessed at baseline and after 6 weeks of training
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.
Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks) resting systolic blood pressure
Time frame: Blood pressure will be assessed after 6 weeks of training and after an additional 12 weeks of training
Systolic blood pressure (SBP) will be measured by absolute change from endpoint 1. SBP will be assessed as described in Outcome 1.
Change from baseline to endpoint 1 (6 weeks) Nitric Oxide-mediated Endothelium Dependent Dilation (EDD)
Time frame: EDD will be assessed at baseline and after 6 weeks of training
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.
Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks) Nitric Oxide-mediated Endothelium Dependent Dilation (EDD)
Time frame: EDD will be assessed after 6 weeks of training and after an additional 12 weeks of training
EDD will be assessed as described in Outcome 3
2 secondary outcomes
Change from baseline to endpoint 1 (6 weeks) cerebrovascular reactivity (CVR)
Time frame: CVR will be assessed at baseline and after 6 weeks of training
Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks)
Time frame: CVR will be assessed after 6 weeks of training and after an additional 12 weeks of training
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dallin Tavoian, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle strength training in people with Hypertension, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to endpoint 1 (6 weeks) resting systolic blood pressure (time frame: Blood pressure will be assessed at baseline and after 6 weeks of training). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.