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

Trial Summary

What is the purpose of this trial?

This research study is investigating whether completing breathing exercises before surgery helps heart transplant patients recover after surgery. Previous studies have shown that breathing exercises can improve breathing, cough, and swallow function in patients with other diseases/conditions. The current study will investigate the impact of a preoperative respiratory muscle strength training program on breathing and cough function, swallow function, patient-reported eating and swallowing fatigue, and health outcomes in individuals undergoing heart transplantation. Participants will: * undergo tests of breathing, cough, and swallow function * complete questionnaires about the treatment, their swallow function * complete breathing exercises daily

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 Respiratory Strength Training for Heart Transplant Recipients?

Research shows that inspiratory muscle training (a type of breathing exercise) improves lung function and respiratory muscle strength in patients undergoing cardiac surgeries, which suggests it could be beneficial for heart transplant recipients as well. ^{1 2 3 4 5}

Is respiratory muscle strength training safe for heart transplant recipients?

Research indicates that respiratory muscle strength training, including prehabilitation before cardiac surgery, is generally safe. In a study with cardiac surgery patients, there were no significant differences in surgical or lung complications between those who did the training and those who did not, and only a small number of adverse events were related to the training. ^{2 5 6 7 8}

How is respiratory strength training different from other treatments for heart transplant recipients?

Respiratory strength training is unique because it focuses on strengthening the muscles used for breathing, which can improve respiratory endurance and overall lung function. Unlike other treatments that may focus on medication or surgical interventions, this therapy involves exercises that specifically target the respiratory muscles to enhance their performance. ^{2 5 9 10 11}

Research Team

Cara Donohue, Ph.D.

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

Not pregnant

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

Have a computer, tablet or electronic device with a stable internet connection for telehealth sessions (outpatient)

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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 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]

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]

References

1. Korea (South) 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. [2021]

2. Pakistan 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. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves tidal volume and vital capacity after CABG surgery. [2019]

4. England 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. [2019]

5. England 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. [2020]

6. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of prehabilitation in patients undergoing elective cardiac surgery. [2023]

7. United States 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. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Respiratory muscle training increases respiratory muscle strength and reduces respiratory complications after stroke: a systematic review. [2018]

9. Singapore pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. [2016]

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

The effects of respiratory training with inspiratory flow resistive loads in premature infants. [2007]

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

Acute Effects of a Respiratory Sprint-Interval Session on Muscle Contractility. [2015]