Respiratory Strength Training for Heart Transplant Recipients

Overseen By Cara Donohue, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Under 18, Over 90, Pregnant, others

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

Compensation: Varies

Number of Visits: 3

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether breathing exercises before heart transplant surgery can aid patient recovery. Researchers aim to determine if these exercises improve breathing, coughing, swallowing, and overall health post-surgery. Participants will be divided into two groups: one performing active respiratory muscle strength training (active breathing exercises) and another doing a sham (inactive) version. Individuals currently undergoing evaluation or on the waiting list for a heart transplant, with internet access for telehealth sessions, might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery for future heart transplant patients.

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 prior data suggests that this respiratory muscle strength training is safe for heart transplant recipients?

Research has shown that breathing exercises, such as respiratory muscle strength training, are generally safe and beneficial. Studies have found that these exercises improve heart and lung function in heart transplant patients. One study found that patients who engaged in respiratory muscle training could breathe better for longer periods without fatigue.

No serious side effects have been reported from these exercises. Designed to be safe, they aid in recovery. The exercises use devices that make the breathing muscles work harder, yet they remain non-harmful.

Overall, the training is well-tolerated and aims to help patients become stronger and feel better after their heart transplant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment options for heart transplant recipients, which typically focus on medication and lifestyle changes to support the new heart, active respiratory muscle strength training targets the respiratory muscles directly. This method uses specialized devices to strengthen these muscles before the transplant, potentially leading to better recovery and improved outcomes post-surgery. Researchers are excited about this approach because it could enhance patients' respiratory efficiency and overall physical readiness for the operation, offering a novel way to optimize transplant success.

What evidence suggests that this trial's treatments could be effective for heart transplant recipients?

This trial will compare active respiratory muscle strength training with sham respiratory muscle strength training for heart transplant recipients. Research has shown that breathing exercises benefit heart transplant patients. Studies have found that exercise can enhance these patients' exercise capacity and cardiovascular function. Specifically, training the muscles used for breathing strengthens them, allowing patients to breathe better for longer periods. This suggests that breathing exercises might aid recovery after a heart transplant by improving breathing, coughing, and swallowing. Stronger breathing muscles could lead to better overall health for heart transplant patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Cara Donohue, Ph.D.

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 who are being evaluated or on the waitlist for a heart transplant at VUMC with a status of 3-6. Participants must be willing to do tests and breathing exercises, not be pregnant, and have internet access for telehealth sessions.

Inclusion Criteria

I am willing to complete tests and an exercise program.

Not pregnant

Undergoing evaluation or actively waitlisted for heart transplantation at VUMC with a waitlist status of 3-6

Exclusion Criteria

No access to a computer, tablet or electronic device with a stable internet connection for telehealth sessions

I am being evaluated for or am on the waitlist for a multiorgan transplant.

Unwilling or unable to undergo testing procedures and complete the exercise training program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Preoperative Respiratory Strength Training

Participants undergo active or sham respiratory muscle strength training using devices from enrollment until heart transplant

2-6 weeks

1 visit (in-person or virtual) per week

Surgery and Immediate Postoperative Evaluation

Participants undergo heart transplantation and a third research evaluation post-surgery

1 week

1 visit (in-person)

Follow-up

Participants are monitored for health outcomes and changes in respiratory and swallow function post-surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active respiratory muscle strength training
• Sham respiratory muscle strength training

Trial Overview The study compares two types of respiratory muscle strength training: an active one that might improve breathing and swallowing functions after heart surgery, versus a sham (placebo) exercise program. It aims to see if pre-surgery exercises can help recovery.

How Is the Trial Designed?

Group I: Active respiratory muscle strength training Experimental Treatment 1 Intervention

Enrolled heart transplant patients will undergo active preoperative respiratory strength training using two respiratory strength training devices from enrollment until they receive a heart transplant.

Group II: Sham respiratory muscle strength training Placebo Group 1 Intervention

Enrolled heart transplant patients will undergo sham preoperative respiratory strength training using two respiratory strength training devices from enrollment until they receive a heart transplant. For individuals completing sham respiratory strength training, the spring will be removed from the devices as has been done in prior sham-controlled trials.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

In a study of 60 patients undergoing coronary artery bypass graft surgery, those who received pre-operative respiratory muscle training showed significantly better performance in the 6-minute walk test compared to those who received conventional treatment, indicating improved post-operative pulmonary health.

Patients who underwent respiratory muscle training also experienced shorter durations of mechanical ventilation, reduced need for oxygen therapy, and shorter hospital stays, all with statistically significant results (P < 0.05).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Pre-operative Respiratory Muscle Training versus Conventional Treatment for Improving Post operative Pulmonary Health after Coronary Artery Bypass Grafting. Sahar, W., Ajaz, N., Haider, Z., et al.[2022]

Respiratory muscle training significantly increases both maximal inspiratory and expiratory pressures in adults with respiratory muscle weakness following a stroke, with improvements of 7 cmH2O and 13 cmH2O respectively, based on a systematic review of five trials involving 263 participants.

This training also reduces the risk of respiratory complications after stroke, with a relative risk of 0.38 compared to no or sham interventions, although it remains uncertain if these improvements translate to better activity and participation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory muscle training increases respiratory muscle strength and reduces respiratory complications after stroke: a systematic review. Menezes, KK., Nascimento, LR., Ada, L., et al.[2018]

Inspiratory muscle training (IMT) significantly improves pulmonary function and respiratory muscle strength in patients undergoing cardiac surgery, with notable increases in forced vital capacity and forced expiratory volume.

IMT also enhances functional capacity, as evidenced by a substantial increase in the 6-minute walk distance, and contributes to a reduced length of hospital stay for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Inspiratory Muscle Training on Respiratory Muscle Strength in Patients Undergoing Cardiac Surgeries: A Systematic Review With Meta-Analysis. Dsouza, FV., Amaravadi, SK., Samuel, SR., et al.[2021]

In a study of 47 patients undergoing coronary artery bypass grafting, both groups experienced a significant reduction in lung function and respiratory muscle strength immediately after surgery, indicating a common postoperative challenge.

However, the group that received inspiratory muscle training showed improved tidal volume and vital capacity by the third postoperative day compared to the control group, suggesting that this training can enhance recovery of respiratory function after cardiac surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves tidal volume and vital capacity after CABG surgery. Matheus, GB., Dragosavac, D., Trevisan, P., et al.[2019]

In a study involving 12 healthy subjects, both respiratory muscle endurance training (RMET) and the new respiratory muscle sprint-interval training (RMSIT) caused significant fatigue in respiratory muscles, indicating that both methods are effective for training.

RMSIT was found to be a time-efficient alternative to RMET, requiring less total work of breathing while still providing a similar metabolic load on the respiratory muscles, without causing any clinically relevant changes in airway properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Effects of a Respiratory Sprint-Interval Session on Muscle Contractility. Wüthrich, TU., Marty, J., Benaglia, P., et al.[2015]

Preoperative inspiratory muscle training was found to be feasible and well-tolerated in a pilot study of 26 high-risk patients scheduled for coronary artery bypass graft surgery, with no adverse events reported.

Patients who underwent inspiratory muscle training experienced significantly fewer cases of postoperative atelectasis compared to the control group, suggesting that this intervention may help reduce pulmonary complications after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of preoperative inspiratory muscle training in patients undergoing coronary artery bypass surgery with a high risk of postoperative pulmonary complications: a randomized controlled pilot study. Hulzebos, EH., van Meeteren, NL., van den Buijs, BJ., et al.[2019]

Expiratory muscle strength training (EMST) significantly improved maximum expiratory pressure by an average of 15.95 cmH2O across nine studies involving various adult populations, indicating its potential benefit in enhancing respiratory muscle strength.

However, despite the increase in maximum expiratory pressure, EMST did not show significant improvements in cough flow or overall pulmonary function, suggesting that while it strengthens respiratory muscles, it may not directly enhance cough effectiveness or lung capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of expiratory muscle strength training on expiratory strength, pulmonary function and cough in the adult population: a systematic review. Templeman, L., Roberts, F.[2020]

Inspiratory muscle strength training (IMST) significantly increases maximal inspiratory pressure and reduces dyspnea in both older adults without COPD and those with COPD, demonstrating its efficacy as a respiratory intervention.

IMST particularly enhances functional status and quality of life in older adults without COPD, suggesting that this training can benefit a broader population beyond just COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. Huang, CH., Yang, GG., Wu, YT., et al.[2016]

In a study of 180 adult patients awaiting elective cardiac surgery, prehabilitation involving exercise and inspiratory muscle training did not significantly improve pre-operative functional exercise capacity compared to standard care, as measured by the six-minute walk test.

However, patients with sarcopenia in the prehabilitation group showed greater improvements in their walking distance, and the prehabilitation group had significantly better inspiratory muscle strength post-surgery, indicating potential benefits for specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of prehabilitation in patients undergoing elective cardiac surgery. Akowuah, EF., Wagnild, JM., Bardgett, M., et al.[2023]

Inspiratory muscle training (IMT) significantly improves inspiratory muscle strength and endurance in individuals with ischemic heart disease (IHD), based on a meta-analysis of 13 studies involving 849 participants.

However, IMT did not show significant benefits in functional exercise capacity, health-related quality of life, or pulmonary function compared to control groups, indicating that while it can enhance muscle strength, its overall impact on exercise performance and quality of life may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Respiratory Muscle Training on Exercise Capacity, Quality of Life, and Respiratory and Pulmonary Function in People With Ischemic Heart Disease: Systematic Review and Meta-Analysis. Fabero-Garrido, R., Del Corral, T., Plaza-Manzano, G., et al.[2023]

In a study of 22 premature infants over 2 weeks, respiratory training using inspiratory flow-resistive loads significantly improved respiratory muscle endurance by 137% in the trained group, while the control group showed no improvement.

The trained infants also experienced a decrease in baseline breathing frequency and a lesser increase in inspiratory time under load, indicating enhanced respiratory efficiency, although there was no significant change in respiratory muscle strength between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of respiratory training with inspiratory flow resistive loads in premature infants. Tan, S., Duara, S., Silva Neto, G., et al.[2007]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06190171

Respiratory Strength Training in Heart Transplant Recipients This research study is investigating whether completing breathing exercises before surgery helps heart transplant patients recover after surgery. Previous ...

2. withpower.com withpower.com/trial/phase-deglutition-disorders-3-2024-f646b

Respiratory Strength Training for Heart Transplant Recipients This research study is investigating whether completing breathing exercises before surgery helps heart transplant patients recover after surgery.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06190171/respiratory-strength-training-in-heart-transplant-recipients

Respiratory Strength Training in Heart Transplant Recipients The current study will investigate the impact of a preoperative respiratory muscle strength training program on breathing and cough function ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8603635/

Exercise training in heart transplantation - PubMed Central - NIH Exercise training improves exercise capacity, cardiac and vascular endothelial function in heart transplant recipients.

5. ahajournals.org ahajournals.org/doi/10.1161/01.CIR.91.2.320

Benefit of Selective Respiratory Muscle Training on ... Eight patients completed the training program. Respiratory muscle endurance was improved with training, as evidenced by increases in maximal sustainable ...