~2 spots leftby Jun 2025

Breathing Muscle Training for Heart Rehabilitation

Recruiting in Palo Alto (17 mi)
Overseen byThomas Olson, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Uremia, Renal impairment, Liver disease, others
No Placebo Group
Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise.
Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Inspiratory Muscle Training for heart rehabilitation?

Research shows that Inspiratory Muscle Training (IMT) can improve respiratory muscle strength and quality of life in patients with heart failure, suggesting it may be beneficial for heart rehabilitation.

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Is inspiratory muscle training safe for humans?

Inspiratory muscle training (IMT) has been widely used in both healthy individuals and those with various health conditions, and it is generally considered safe for improving respiratory muscle strength and other health parameters.

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How does breathing muscle training differ from other heart rehabilitation treatments?

Breathing muscle training is unique because it focuses on strengthening the muscles used for breathing, which can improve overall respiratory function and endurance. Unlike other heart rehabilitation treatments that may focus on medication or physical exercise, this approach specifically targets the respiratory muscles to enhance breathing efficiency and potentially improve heart health.

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Eligibility Criteria

This trial is for adults over 18 who speak English. There are two groups: one with heart failure patients eligible for cardiac rehab, and a healthy control group without lung, heart, or other major diseases. Participants must be able to exercise and give consent. Those with liver disease, uremia, iodide allergies, or poor kidney function (creatinine >1.3 mg/dL) can't join.

Inclusion Criteria

I am over 18, speak English, and don't have major health issues.
I am an adult with heart failure and qualify for cardiac rehab.

Exclusion Criteria

I have heart failure and can't participate in a structured exercise program.
I am able and willing to give informed consent.
I have kidney problems or am allergic to iodides.
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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform inspiratory muscle training at specified pressures for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Participant Groups

The study tests if breathing muscle training improves blood flow and pressure during exercise when added to standard cardiac rehabilitation in people with heart failure compared to healthy individuals matched by age and sex.
2Treatment groups
Active Control
Placebo Group
Group I: Non-sham armActive Control1 Intervention
Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.
Group II: Sham armPlacebo Group1 Intervention
Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?

Mayo ClinicLead Sponsor

References

[Inspiratory muscle training during pulmonary rehabilitation]. [2021]Inspiratory muscle training (IMT) is part of the management of patients with pulmonary diseases during rehabilitation. Since the last recommendations of the Société de pneumologie de langue française, several studies have focused on the role of inspiratory muscle training during pulmonary rehabilitation.
Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). [2023]Inspiratory muscle training (IMT) aims to improve respiratory muscle strength and endurance. Clinical trials used various training protocols, devices and respiratory measurements to check the effectiveness of this intervention. The current guidelines reported a possible advantage of IMT, particularly in people with respiratory muscle weakness. However, it remains unclear to what extent IMT is clinically beneficial, especially when associated with pulmonary rehabilitation (PR). OBJECTIVES: To assess the effect of inspiratory muscle training (IMT) on chronic obstructive pulmonary disease (COPD), as a stand-alone intervention and when combined with pulmonary rehabilitation (PR).
Inspiratory Muscle Training in Patients With Heart Failure: What Is New? Systematic Review and Meta-Analysis. [2021]The benefits of inspiratory muscle training (IMT) have already been demonstrated in patients with heart failure (HF), but the best mode of training and which patients benefit from this intervention are not clear. The purpose of this study was to review the effects of IMT on respiratory muscle strength, functional capacity, pulmonary function, quality of life, and dyspnea in patients with HF; IMT isolated or combined with another intervention (combined IMT), the presence of inspiratory muscle weakness, training load, and intervention time were considered.
Inspiratory muscle training in patients with chronic obstructive pulmonary disease: the state of the evidence. [2022]The purpose of the present review was to assess the quality of evidence in the literature regarding the specific benefits of inspiratory muscle training (IMT) with an emphasis on training intensity and the relationships between changes in inspiratory muscle function and other clinical outcome measures.
Effects of a new respiratory muscle training device in community-dwelling elderly men: an open-label, randomized, non-inferiority trial. [2022]Respiratory muscle training (RMT) has various clinical benefits in older adults; however, the low adherence to training remains a challenging issue. The present study aimed to confirm the efficacy of a new device that combines inspiratory muscle training and a positive expiratory pressure (IMT/PEP) compared to that of a Threshold IMT device (Philips Respironics Inc), and to determine whether home-based training differed from rehabilitation center training.
Inspiratory muscle training improves the swimming performance of competitive young male sprint swimmers. [2021]Inspiratory muscle training (IMT) stimulates the strengthening of the respiratory muscles by placing a resistance to the entry of air into the lung. The objective was to observe the effect of IMT on swimming performance, and its relationship with inspiratory strength and lung function.
Feasibility, safety, and patient acceptability of electronic inspiratory muscle training in patients who require prolonged mechanical ventilation in the intensive care unit: A dual-centre observational study. [2023]Inspiratory muscle training (IMT) is an intervention that can be used to rehabilitate the respiratory muscle deconditioning experienced by patients with critical illness, requiring prolonged mechanical ventilation. Clinicians are currently using mechanical threshold IMT devices that have limited resistance ranges.
The effects of inspiratory muscle training on balance and functional mobility: a systematic review. [2023]Inspiratory muscle training (IMT) has been widely used in both healthy and diseased populations especially in older adults, and its effects have been proven not only on inspiratory muscle strength but also on dyspnea, exercise capacity, quality of life, and other health parameters.