Postmenopausal DisorderCardioBreathNCT03672760
Inspiratory Muscle Training X CardioBreath App Effects On Vagal Modulation And Pulse Wave Velocity
A study testing CardioBreathApp and IMT PowerBreath in people with Postmenopausal Disorder and Autonomic Imbalance, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Existing data points to relevant beneficial effects of respiratory exercises on cardiovascular health, with special regards to decreases on arterial pressure and improves on autonomic and vascular profiles, though mechanistics of such results have not yet been cleared. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Disorder, Autonomic Imbalance, Vascular Stiffness
- What is being tested?
- CardioBreathApp and IMT PowerBreath
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2023to 30 Jul 2025
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Follicle Stimulating Hormone (FSH)>35mui/ml
- minimum 12 months amenorrhea
- sedentary life style (less than 150 minutes per week of exercise)
Who cannot join
- Hypertension
- Diabetes
- Obesity
- Use of Betablockers
- recent cardiovascular events or surgery
- renal alterations
Show all 9Show fewer
- respiratory and/or motor pathologies
- smoking
- BMI>29,9
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90620-000
CLAUDIA FETTER, Ph.D., 51984516888, profclaudiafetter@gmail.com
About this study
Official title: Inspiratory Muscle Training X CardioBreath App Effects On Vagal Modulation And Pulse Wave Velocity On Normotensive Postmenopause Women : Randomized Clinical Trial
Existing data points to relevant beneficial effects of respiratory exercises on cardiovascular health, with special regards to decreases on arterial pressure and improves on autonomic and vascular profiles, though mechanistics of such results have not yet been cleared. Among the available ways to perform respiratory exercises, there is the highly recommended Inspiratory Muscle Training (IMT) and slow breathing exercises like Yoga pranayamas. Lately, the development of new technologies has allowed the use of Apps to perform respiratory exercises. This study will be take the just developed CardioBreath®App to validate it as a tool to perform respiratory exercises. Therefore, it will be compared to IMT on cardiac vagal modulation and pulse wave velocity on normotensive post menopause women.
Read the detailed description
Menopause years represent an increasing risk for hypertension and autonomic nervous system (ANS) and vascular imbalance. Existing data point to beneficial effects of respiratory exercises either on ANS and light on therapeutic relevance of these kind of exercises on prevention and treatment of cardiovascular and pulmonary diseases. However, few data is available about the effects of respiratory exercises on both vascular function and interactions with ANS. Besides that, recommendations of slower respiratory rates are associated to healthier physical and psychological states. Among available techniques to perform breathing exercises, most referenced are Inspiratory Muscle Training (IMT) and Yoga based slow breathing (pranayamas). New technologies have allowed the development of Apps which aim to ease the possibilities of exercising breathing.
IMT uses a mouth device for pressure adjustment and presents a variety e training forms including combinations of intensity and volume through loads adjustment. It aims the enhancement of respiratory muscles strength and endurance.
CardioBreath®App has been developed by experienced physical education and yoga professional based on individual prescription of respiratory rates to workout through voice and image guidance of both posture and breathing technique. The performance might be followed through a progression map. It´s available in portuguese language for Android and Ios, has been submitted to Brazilian Trend Marks Institute (INPI) which has not shown opposition to the registration.
It´s a randomized clinical trial recruiting normotensive post menopause women. Eligible participants will be assessed by Finometer for blood pressure and heart rate variability as measures for autonomic outcomes. Data analysis of these data will be processed by CardioSeries software through Fourier fast transform (FFT) in order to generate vagal and sympathetic values. For pulse wave velocity and central arterial pressure the participants will be assessed by Complior Analyser.
The participants will be randomized into 3 intervention groups as follows: IMT, IMT placebo and CardioBreath®App. The intervention will long five weeks. The exercises will be performed at home for five days/ week during 10 minutes and will be registered by audio for whatsapp (IMT) and "Progress" graphics (CardioBreath®App) Once a week they will visit the laboratory set to adjust loads (IMT) and respiratory rates in CardioBreath®App groups, respectively.
After five weeks the participants will be re-evaluated for all outcomes described above.
Data analysis will be provided by ANOVA of two repeated measures and Bonferroni post hoc. All data will be presented in mean +- standard deviation.
- Being tested
- CardioBreathApp, IMT PowerBreath, IMT PowerBreath Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioBreathAppDevice
Respiratory exercises performed with CardioBreathApp prescription and voice and visual guidance
IMT PowerBreathDevice
Inspiratory Muscle Training (IMT) performed with 30% load based on Maximal Inspiratory Pressure
IMT PowerBreath PlaceboDevice
Inspiratory Muscle Training (IMT) without load
| Study group | Role | What they receive |
|---|---|---|
| IMT PowerBreath | Active comparator | Participants will have PowerBreath device for IMT adjusted for 30% of maximal inspiratory pressure and will perform the exercise at home for five days/week during 10 minutes for five weeks.
An once a week meeting will provide re-adjustment of load through maximal inspiratory pressure performance Receives: Device: IMT PowerBreath |
| IMT PowerBreath Placebo | Placebo comparator | Participants will have PowerBreath device for IMT with no load and will perform the exercise at home for five days/week during 10 minutes for five weeks.
An once a week meeting will not re-adjustment the load though maximal inspiratory pressure performance will be performed Receives: Device: IMT PowerBreath Placebo |
| CardioBreathApp | Active comparator | CardioBreathApp group will have the app settings of profile and spontaneous respiratory rate to determine the exercise rate of exercises, which will be performed at home for five days/week during 10 minutes for five weeks An once a week meeting will provide re-adjustment of respiratory rate to perform exercises Receives: Device: CardioBreathApp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular autonomic control by heart rate variability(HRV)
High Frequency (HF) component of HRV (ms2 = squared milliseconds) as measure of vagal modulation
Measured: 30 minutes
Secondary outcomes (1)
Carotid -femoral pulse wave velocity (Complior)
Reduction of carotid -femoral pulse wave velocity (m/s)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Sep 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal DisorderStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The participants will be randomized into 3 intervention groups as follows: IMT, IMT placebo and CardioBreath®App. The intervention will long five weeks. The exercises will be performed at home for five days/ week during 10 minute
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672760
- Sponsor's protocol ID
- Cardiology
- Acronym
- CardioBreath
- Status last verified
- Jun 2024
- First submitted
- 6 Sep 2018
- Last updated
- 21 Jun 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training X CardioBreath App Effects On Vagal Modulation And Pulse Wave Velocity On Normotensive Postmenopause Women : Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03672760
- Acronym / sponsor ID
- CardioBreath / Cardiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 14 Sep 2018 (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.
Existing data points to relevant beneficial effects of respiratory exercises on cardiovascular health, with special regards to decreases on arterial pressure and improves on autonomic and vascular profiles, though mechanistics of such results have not yet been cleared. Among the available ways to perform respiratory exercises, there is the highly recommended Inspiratory Muscle Training (IMT) and slow breathing exercises like Yoga pranayamas. Lately, the development of new technologies has allowed the use of Apps to perform respiratory exercises. This study will be take the just developed CardioBreath®App to validate it as a tool to perform respiratory exercises. Therefore, it will be compared to IMT on cardiac vagal modulation and pulse wave velocity on normotensive post menopause women.
Detailed description
Menopause years represent an increasing risk for hypertension and autonomic nervous system (ANS) and vascular imbalance. Existing data point to beneficial effects of respiratory exercises either on ANS and light on therapeutic relevance of these kind of exercises on prevention and treatment of cardiovascular and pulmonary diseases. However, few data is available about the effects of respiratory exercises on both vascular function and interactions with ANS. Besides that, recommendations of slower respiratory rates are associated to healthier physical and psychological states. Among available techniques to perform breathing exercises, most referenced are Inspiratory Muscle Training (IMT) and Yoga based slow breathing (pranayamas). New technologies have allowed the development of Apps which aim to ease the possibilities of exercising breathing.
IMT uses a mouth device for pressure adjustment and presents a variety e training forms including combinations of intensity and volume through loads adjustment. It aims the enhancement of respiratory muscles strength and endurance.
CardioBreath®App has been developed by experienced physical education and yoga professional based on individual prescription of respiratory rates to workout through voice and image guidance of both posture and breathing technique. The performance might be followed through a progression map. It´s available in portuguese language for Android and Ios, has been submitted to Brazilian Trend Marks Institute (INPI) which has not shown opposition to the registration.
It´s a randomized clinical trial recruiting normotensive post menopause women. Eligible participants will be assessed by Finometer for blood pressure and heart rate variability as measures for autonomic outcomes. Data analysis of these data will be processed by CardioSeries software through Fourier fast transform (FFT) in order to generate vagal and sympathetic values. For pulse wave velocity and central arterial pressure the participants will be assessed by Complior Analyser.
The participants will be randomized into 3 intervention groups as follows: IMT, IMT placebo and CardioBreath®App. The intervention will long five weeks. The exercises will be performed at home for five days/ week during 10 minutes and will be registered by audio for whatsapp (IMT) and "Progress" graphics (CardioBreath®App) Once a week they will visit the laboratory set to adjust loads (IMT) and respiratory rates in CardioBreath®App groups, respectively.
After five weeks the participants will be re-evaluated for all outcomes described above.
Data analysis will be provided by ANOVA of two repeated measures and Bonferroni post hoc. All data will be presented in mean +- standard deviation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The participants will be randomized into 3 intervention groups as follows: IMT, IMT placebo and CardioBreath®App. The intervention will long five weeks. The exercises will be performed at home for five days/ week during 10 minute
| Arm | Type | Receives |
|---|---|---|
| IMT PowerBreath | Active comparator | Device: IMT PowerBreathParticipants will have PowerBreath device for IMT adjusted for 30% of maximal inspiratory pressure and will perform the exercise at home for five days/week during 10 minutes for five weeks. An once a week meeting will provide re-adjustment of load through maximal inspiratory pressure performance |
| IMT PowerBreath Placebo | Placebo comparator | Device: IMT PowerBreath PlaceboParticipants will have PowerBreath device for IMT with no load and will perform the exercise at home for five days/week during 10 minutes for five weeks. An once a week meeting will not re-adjustment the load though maximal inspiratory pressure performance will be performed |
| CardioBreathApp | Active comparator | Device: CardioBreathAppCardioBreathApp group will have the app settings of profile and spontaneous respiratory rate to determine the exercise rate of exercises, which will be performed at home for five days/week during 10 minutes for five weeks An once a week meeting will provide re-adjustment of respiratory rate to perform exercises |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Follicle Stimulating Hormone (FSH)>35mui/ml
- minimum 12 months amenorrhea
- sedentary life style (less than 150 minutes per week of exercise)
Key exclusion criteria (9 listed)
- Hypertension
- Diabetes
- Obesity
- Use of Betablockers
- recent cardiovascular events or surgery
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 |
|---|---|---|
| CardioBreathAppRespiratory exercises performed with CardioBreathApp prescription and voice and visual guidance | Device | CardioBreathApp |
| IMT PowerBreathInspiratory Muscle Training (IMT) performed with 30% load based on Maximal Inspiratory Pressure | Device | IMT PowerBreath |
| IMT PowerBreath PlaceboInspiratory Muscle Training (IMT) without load | Device | IMT PowerBreath Placebo |
Primary outcome
Cardiovascular autonomic control by heart rate variability(HRV)
Time frame: 30 minutes
High Frequency (HF) component of HRV (ms2 = squared milliseconds) as measure of vagal modulation
1 secondary outcome
Carotid -femoral pulse wave velocity (Complior)
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioBreathApp and IMT PowerBreath in people with Postmenopausal Disorder and Autonomic Imbalance, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Jun 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cláudia Fetter, MSc (+5551984516888, profclaudiafetter@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular autonomic control by heart rate variability(HRV) (time frame: 30 minutes). 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 21 Jun 2024.