Respiratory Training for Heart Failure

(RETRO Trial)

Overseen By Daniel E. Forman, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Dementia, Severe COPD, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

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 ≥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. ^{1 2 3 4 5}

Is 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. ^{2 5 6 7 8}

How 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. ^{2 4 5 6 8}

Research Team

Daniel Forman, MD

Principal Investigator

University of Pittsburgh

Eligibility 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.

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

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

Treatment Details

Interventions

• Inspiratory Muscle Training (IMT)

Trial Overview 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.

Participant Groups

Group I: IMT Group: Inspiratory Muscle Training (IMT) Experimental Treatment 1 Intervention

IMT exercise sessions addition to standard of care.

Group II: Standard of Care Active Control 1 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:

Approved in European Union as Inspiratory Muscle Training for:

• Heart Failure
• Chronic Obstructive Pulmonary Disease (COPD)
• Respiratory Muscle Weakness

Approved in United States as Inspiratory Muscle Training for:

• Heart Failure
• Respiratory Muscle Weakness
• Pulmonary Rehabilitation

Approved in Canada as Inspiratory Muscle Training for:

• Heart Failure
• Chronic Obstructive Pulmonary Disease (COPD)
• Respiratory Muscle Weakness

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

The Pittsburgh Foundation

Collaborator

Trials

8

Recruited

470+

Findings from Research

Inspiratory muscle training (IMT) significantly improved inspiratory strength and endurance in patients with chronic heart failure (CHF), as evidenced by increased maximum inspiratory pressure and sustained maximal inspiratory pressure after 10 weeks of training.

Patients undergoing IMT also experienced enhanced exercise capacity, reduced dyspnea, and improved quality of life, demonstrating the efficacy of this intervention in managing symptoms of CHF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training using an incremental endurance test alleviates dyspnea and improves functional status in patients with chronic heart failure. Laoutaris, I., Dritsas, A., Brown, MD., et al.[2019]

Inspiratory muscle training (IMT) significantly improves respiratory muscle strength, functional capacity, and reduces dyspnea in patients with stable heart failure, based on a review of 12 clinical trials.

Typical IMT protocols involved daily sessions lasting 20 to 30 minutes at an intensity greater than 30% of maximal inspiratory pressure, leading to moderate to large effect sizes in key outcomes like inspiratory pressure and walking distance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in patients with heart failure: a systematic review. Lin, SJ., McElfresh, J., Hall, B., et al.[2021]

In a study of 25 male patients with chronic heart failure, adding inspiratory muscle training (IMT) to aerobic and resistance training significantly improved maximal inspiratory pressure, resting heart rate, heart rate reserve, and health-related quality of life compared to a control group that received sham IMT.

The results suggest that IMT can enhance the benefits of traditional exercise training in cardiac rehabilitation for patients with ischemic heart failure, indicating its potential as a valuable complementary therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ahmad, AM., Hassan, MH.[2022]

Inspiratory muscle training (IMT) combined with pulmonary rehabilitation (PR) did not show significant improvements in dyspnea, functional exercise capacity, or health-related quality of life in COPD patients, based on a review of 55 randomized controlled trials involving 4,467 participants.

However, IMT alone may lead to better outcomes in these areas, suggesting that while IMT can be beneficial, its effectiveness may be diminished when combined with PR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). Ammous, O., Feki, W., Lotfi, T., et al.[2023]

Isolated inspiratory muscle training (IMT) significantly improves inspiratory muscle strength, functional capacity (measured by the 6-Minute Walk Test), and quality of life in patients with heart failure, based on a systematic review of 14 studies.

IMT is particularly beneficial for patients with inspiratory muscle weakness, and higher training loads and longer intervention times lead to greater improvements, making it a valuable adjuvant therapy for those unable to participate in conventional rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training in Patients With Heart Failure: What Is New? Systematic Review and Meta-Analysis. Azambuja, ACM., de Oliveira, LZ., Sbruzzi, G.[2021]

A study involving 40 critically ill patients showed that using an electronic device for inspiratory muscle training (IMT) was feasible, with 81% of planned sessions completed, indicating good adherence to the intervention.

The electronic IMT was found to be safe, with no major adverse events and only 10% minor adverse events that were transient and without clinical consequences, while over 85% of participants reported it as helpful for their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Nickels, M., Erwin, K., McMurray, G., et al.[2023]

A 4-week high-intensity inspiratory muscle training (hi-IMT) program significantly improved inspiratory muscle strength by 57.2% and endurance by 72.7% in patients with chronic heart failure, compared to much lower improvements in the control group.

The study, involving 22 patients, demonstrated that hi-IMT is a safe and feasible intervention with no adverse effects, highlighting its potential as an effective therapy for respiratory muscle dysfunction in chronic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity vs. sham inspiratory muscle training in patients with chronic heart failure: a prospective randomized trial. Marco, E., Ramírez-Sarmiento, AL., Coloma, A., et al.[2020]

Inspiratory muscle training (IMT) improves the strength and endurance of inspiratory muscles, reduces dyspnoea during daily activities, and enhances quality of life, but does not offer additional benefits when combined with standard pulmonary rehabilitation programs.

IMT is beneficial for patients who cannot engage in full exercise training, and it shows promise in pre-operative programs, suggesting it may be a useful intervention in specific contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training during pulmonary rehabilitation]. Beaumont, M., Le Tallec, F., Villiot-Danger, E.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training using an incremental endurance test alleviates dyspnea and improves functional status in patients with chronic heart failure. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in patients with heart failure: a systematic review. [2021]

3. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training in Patients With Heart Failure: What Is New? Systematic Review and Meta-Analysis. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

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]

7. England pubmed.ncbi.nlm.nih.gov

High-intensity vs. sham inspiratory muscle training in patients with chronic heart failure: a prospective randomized trial. [2020]

8. France pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training during pulmonary rehabilitation]. [2021]