Respiratory Training for Heart Failure
(RETRO Trial)
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pittsburgh
Disqualifiers: Dementia, Severe COPD, Anemia, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?In a randomized controlled trial, to study the utility of inspiratory muscle training (IMT) to improve functional outcomes in adults aged β₯70 years with heart failure (HF) who have been referred to palliative care for end-stage HF management.
* The study team hypothesize that older HF patients will be able to use IMT safely, reliably, and effectively in a 12-week home-based training regimen.
* The study team hypothesize that physical function (sit to stand, gait speed, grip strength), respiratory/pulmonary function, self-efficacy, fatigue and quality of life will increase among older HF patients randomized IMT versus those randomized to usual care.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should be on optimal therapy according to heart failure guidelines, which suggests you may need to continue your current heart failure treatment.
What data supports the effectiveness of the treatment Inspiratory Muscle Training (IMT) for heart failure?
Research shows that Inspiratory Muscle Training (IMT) can help improve breathing strength, functional capacity, and quality of life in people with heart failure. It has also been found to reduce shortness of breath and improve overall health status in patients with chronic heart failure.
12345Is inspiratory muscle training (IMT) safe for humans?
Research indicates that inspiratory muscle training (IMT) is generally safe for humans, including those with heart failure and other conditions requiring respiratory rehabilitation.
25678How is the treatment Inspiratory Muscle Training (IMT) different from other treatments for heart failure?
Inspiratory Muscle Training (IMT) is unique because it specifically targets and strengthens the muscles used for breathing, which can improve respiratory muscle strength and endurance. Unlike other heart failure treatments that may focus on medication or lifestyle changes, IMT is a physical training method that can enhance breathing capacity and potentially improve quality of life for patients with heart failure.
24568Eligibility Criteria
This trial is for adults aged 70 or older with heart failure who are receiving palliative care for end-stage management of their condition. Participants should be able to perform a home-based training regimen.Inclusion Criteria
I am either male or female.
I am over 70 years old.
I am following the best heart failure treatment guidelines.
+1 more
Exclusion Criteria
I have severe heart valve disease.
My heart failure isn't due to untreated major valve problems, or it's been a year since my valve replacement.
Dementia
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a 12-week home-based Inspiratory Muscle Training (IMT) program
12 weeks
Weekly monitoring (virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing Inspiratory Muscle Training (IMT) compared to standard care, hypothesizing that IMT will improve physical and respiratory function, self-efficacy, fatigue levels, and overall quality of life over a 12-week period.
2Treatment groups
Experimental Treatment
Active Control
Group I: IMT Group: Inspiratory Muscle Training (IMT)Experimental Treatment1 Intervention
IMT exercise sessions addition to standard of care.
Group II: Standard of CareActive Control1 Intervention
Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.
Inspiratory Muscle Training (IMT) is already approved in European Union, United States, Canada for the following indications:
πͺπΊ Approved in European Union as Inspiratory Muscle Training for:
- Heart Failure
- Chronic Obstructive Pulmonary Disease (COPD)
- Respiratory Muscle Weakness
πΊπΈ Approved in United States as Inspiratory Muscle Training for:
- Heart Failure
- Respiratory Muscle Weakness
- Pulmonary Rehabilitation
π¨π¦ Approved in Canada as Inspiratory Muscle Training for:
- Heart Failure
- Chronic Obstructive Pulmonary Disease (COPD)
- Respiratory Muscle Weakness
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of PittsburghPittsburgh, PA
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Who Is Running the Clinical Trial?
University of PittsburghLead Sponsor
The Pittsburgh FoundationCollaborator
References
Inspiratory muscle training using an incremental endurance test alleviates dyspnea and improves functional status in patients with chronic heart failure. [2019]The benefits of inspiratory muscle training (IMT) in patients with chronic heart failure (CHF) have been inadequately studied.
Inspiratory muscle training in patients with heart failure: a systematic review. [2021]The purpose of this review was to assess the quality of evidence on inspiratory muscle training (IMT) in patients with heart failure and to provide an overview on subject selection, training protocols, and outcome achieved with IMT.
Effects of Addition of Inspiratory Muscle Training to Exercise-Based Cardiac Rehabilitation on Inspiratory Muscle Strength, Peak Oxygen Consumption, and Selected Hemodynamics in Chronic Heart Failure. [2022]Evidence supports the clinical benefits of isolated inspiratory muscle training (IMT) in patients with chronic heart failure (CHF); however, the rationale of IMT in combination with exercise training in cardiac rehabilitation settings for CHF has yet to be confirmed.
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.
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.
High-intensity vs. sham inspiratory muscle training in patients with chronic heart failure: a prospective randomized trial. [2020]The purpose of this study was to evaluate the effectiveness, feasibility, and safety of a 4-week high-intensity inspiratory muscle training (hi-IMT) in patients with chronic heart failure (CHF).
[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.