Inspiratory Muscle Training for Orthopedic Surgery Recovery

Overseen By Tatiana Elias-Grajeda

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Corticosteroids, Antibiotics

Disqualifiers: Neurologic conditions, Severe COPD, others

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

Compensation: Varies

Number of Visits: 1

36 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to evaluate effects of respiratory strengthening exercises on breathing function, in people who have orthopedic surgery. It is known that breathing function decreases for a few days after surgery. in In this study, we want to see if exercising before surgery strengthens the breathing muscles and improves recovery after surgery.

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 Orthopedic Surgery Recovery?

Inspiratory muscle training (IMT) has shown potential benefits in improving respiratory muscle strength and endurance, particularly in patients with respiratory muscle weakness, as seen in studies involving chronic obstructive pulmonary disease (COPD) and lung surgery. Additionally, IMT has been found to improve oxygenation and reduce complications in high-risk patients after lung cancer surgery. ^{1 2 3 4 5}

Is inspiratory muscle training safe for humans?

Inspiratory muscle training (IMT) has been used safely in various conditions, including for patients with prolonged mechanical ventilation and those with pulmonary diseases. While the effectiveness can vary, no significant safety concerns have been reported in the studies available. ^{1 2 3 6 7}

How is the treatment Inspiratory Muscle Training (IMT) unique for orthopedic surgery recovery?

Inspiratory Muscle Training (IMT) is unique because it focuses on strengthening the muscles used for breathing, which can help improve overall respiratory function and physical performance. This approach is different from typical orthopedic recovery treatments that may not specifically target respiratory muscles. ^{1 2 3 5 8}

Research Team

Stefan Braunecker, MD

Principal Investigator

University of Florida College of Medicine-Jacksonville

Barbara Smith, PhD

Principal Investigator

University of Florida, College of Public Health and Health Professions - Gainesville

Eligibility Criteria

This trial is for adults over 18 who have smoked or currently smoke, may have lung disease, and are undergoing orthopedic surgery. They should be able to do breathing exercises and report any issues like pain. People with severe lung obstruction, very poor health status, recent serious infections, oxygen dependency, certain neurological conditions or those in pulmonary rehab can't join.

Inclusion Criteria

Ability to communicate adverse effects such as pain or fatigue or the need for assistance

I have lung problems due to smoking.

You have used tobacco or nicotine-containing products in the past or currently.

Exclusion Criteria

I need to use extra oxygen all the time.

I have had pneumonia or a lung infection in the last two weeks that needed steroids or antibiotics.

I have severe lung disease with less than half the normal airflow.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preoperative Inspiratory Muscle Training

Participants undergo inspiratory muscle training exercises 2-4 weeks prior to surgery to strengthen breathing muscles

2-4 weeks

Daily sessions (self-reported)

Surgery and Immediate Postoperative

Participants undergo surgery and are monitored for immediate postoperative changes in breathing function

24 hours

Inpatient monitoring

Follow-up

Participants are monitored for post-operative pulmonary complications and recovery

10 days

Follow-up visits as needed

Treatment Details

Interventions

• Acute Inspiratory Muscle Training (aIMT)
• Daily Inspiratory Muscle Training (dIMT)
• Standard of Care (SOC)

Trial Overview The study tests if pre-surgery breathing exercises (acute or daily) can improve recovery compared to standard care in patients having joint surgery. It aims to see whether these exercises before surgery help strengthen the respiratory muscles and enhance postoperative breathing function.

Participant Groups

Group I: Daily IMT (dIMT) Experimental Treatment 1 Intervention

IMT (inspiratory muscle training) is a treatment strategy aimed to strengthen the muscles of inspiration, the diaphragm and external intercostals, by increasing their force-generating capacity. Participants in the dIMT (daily IMT) will complete daily inspiratory training exercises 2-4 weeks prior to surgery. A pressure threshold training device containing an adjustable-tension spring to provide resistance during inspiration will be used. Subjects will complete 5 sets of 5 maximal volume and speed breaths daily at a pressure 70% of MIP and will rest 1 minute between sets. They will be asked to keep a log to track their sessions to evaluate compliance with the exercise regimen.

Group II: Standard of Care (SOC) Active Control 1 Intervention

The SOC group will receive the usual surgical standard of care only.

Group III: Acute IMT (aIMT) Active Control 1 Intervention

Patients in the aIMT (acute IMT) experimental group will complete a single session of IMT guided by a physical therapist within 30 minutes of anesthesia induction in addition to standard of care. The adjustable pressure threshold training device to provide resistance during inspiration will be used. Subjects will complete 5 sets of 5 maximal volume and speed breaths, and rest 1 minute between sets. The training intensity will be set at 70% of MIP.

Acute Inspiratory Muscle Training (aIMT) is already approved in United States, European Union for the following indications:

Approved in United States as Inspiratory Muscle Strength Training for:

• Pre-operative care for orthopedic surgery
• Improvement of respiratory function post-surgery

Approved in European Union as Inspiratory Muscle Strength Training for:

• Rehabilitation of respiratory function
• Pre-operative care for various surgeries

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

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]

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]

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]

Two weeks of inspiratory muscle training (IMT) did not preserve respiratory muscle strength in high-risk patients undergoing lung cancer surgery, as measured by maximal inspiratory and expiratory pressures, but it did improve oxygen saturation levels postoperatively.

The incidence of pneumonia was similar between the IMT group and the control group, suggesting that IMT did not significantly reduce the risk of postoperative pulmonary complications, although it showed a trend towards better oxygenation on days 3 and 4 after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative inspiratory muscle training in addition to breathing exercises and early mobilization improves oxygenation in high-risk patients after lung cancer surgery: a randomized controlled trial. Brocki, BC., Andreasen, JJ., Langer, D., et al.[2022]

Perioperative respiratory muscle training (RMT) significantly improved postoperative respiratory muscle strength, as indicated by an increase in maximal inspiratory pressure (MIP) by 8.13 cmH2O in a meta-analysis of 7 studies involving 240 participants.

RMT also enhanced postoperative physical activity levels, suggesting it may be beneficial for recovery in patients undergoing lung surgery, although further research with larger sample sizes is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative respiratory muscle training improves respiratory muscle strength and physical activity of patients receiving lung surgery: A meta-analysis. Yang, MX., Wang, J., Zhang, X., et al.[2022]

Inspiratory muscle training (IMT) significantly improved inspiratory strength and lung function in young swimmers, with notable increases in the S-Index and maximum inspiratory flow after a four-week program.

Swimmers who underwent IMT showed significantly faster swimming times in 50-m, 100-m, and 200-m events compared to a control group, indicating that enhanced respiratory muscle strength positively impacts swimming performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves the swimming performance of competitive young male sprint swimmers. Yañez-Sepulveda, R., Alvear-Ordenes, I., Tapia-Guajardo, A., et al.[2021]

A study involving 21 elderly patients undergoing inspiratory muscle training (IMT) found that a single short session did not significantly affect heart rate or blood pressure, indicating that IMT is clinically safe for this population.

While 33% of patients experienced minor cardiac arrhythmias during IMT, these were mostly isolated premature ventricular contractions and did not lead to any abnormal clinical symptoms, suggesting that IMT can be safely incorporated into cardiopulmonary rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute hemodynamic and electrocardiographic responses to a session of inspiratory muscle training in cardiopulmonary rehabilitation. Ramos, PS., Da Costa Da Silva, B., Gomes Da Silva, LO., et al.[2017]

Inspiratory muscle training (IMT) significantly improved inspiratory muscle strength and efficiency in 22 professional male soccer players, leading to enhanced performance in repeated sprint ability (RSA) and reduced sprint times after a 2-week intervention.

The study found significant increases in maximal inspiratory pressure (MIP) and peak inspiratory flow (PIF), indicating that IMT not only boosts muscle strength but also enhances overall exercise tolerance in athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves performance of a repeated sprints ability test in professional soccer players. Cavalcante Silva, RL., Hall, E., Maior, AS.[2020]

References

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

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

2. 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]

3. France pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

Postoperative inspiratory muscle training in addition to breathing exercises and early mobilization improves oxygenation in high-risk patients after lung cancer surgery: a randomized controlled trial. [2022]

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

Perioperative respiratory muscle training improves respiratory muscle strength and physical activity of patients receiving lung surgery: A meta-analysis. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves the swimming performance of competitive young male sprint swimmers. [2021]

7. Italy pubmed.ncbi.nlm.nih.gov

Acute hemodynamic and electrocardiographic responses to a session of inspiratory muscle training in cardiopulmonary rehabilitation. [2017]

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

Inspiratory muscle training improves performance of a repeated sprints ability test in professional soccer players. [2020]