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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how specific breathing exercises might aid recovery after orthopedic surgery. Researchers aim to determine if these exercises, performed before or around the time of surgery, can strengthen breathing muscles and enhance overall recovery. The trial includes two groups: one performs a single session of breathing exercises (Acute Inspiratory Muscle Training, aIMT) right before surgery, while the other engages in daily exercises (Daily Inspiratory Muscle Training, dIMT) for several weeks prior to surgery. Individuals with a history of smoking-related lung disease or who experience shortness of breath with minimal activity may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve recovery for future 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 these respiratory strengthening exercises are safe for orthopedic surgery recovery?

Research has shown that Inspiratory Muscle Training (IMT) is generally safe. In one study with 195 participants using IMT, no negative side effects occurred, and their vital signs remained stable. Another study with older adults found that a single IMT session did not change their heart rate, indicating it is well-tolerated.

This trial uses two types of training: Acute IMT (aIMT) and Daily IMT (dIMT). Research on these methods shows that IMT can strengthen breathing muscles without causing harm. Specifically, improvements in maximum inspiratory pressure, which measures the strength of breathing muscles, have been observed. Overall, studies suggest that IMT is safe and can help strengthen breathing muscles before surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for orthopedic surgery recovery, which typically focuses on post-operative rehabilitation, acute inspiratory muscle training (aIMT) and daily inspiratory muscle training (dIMT) aim to strengthen breathing muscles before surgery. The aIMT is distinctive because it provides a single, intensive session of inspiratory training right before surgery, potentially enhancing lung function during recovery. On the other hand, dIMT involves a pre-surgery regimen where patients regularly train their breathing muscles, which could lead to improved surgical outcomes. Researchers are excited about these methods because they target the respiratory system, which is often overlooked in orthopedic recovery, potentially shortening recovery time and improving overall surgical success.

What evidence suggests that this trial's treatments could be effective for orthopedic surgery recovery?

Research has shown that inspiratory muscle training (IMT) strengthens breathing muscles and improves lung function. Studies have found that IMT significantly increases muscle strength and exercise capacity, aiding recovery after surgery. In this trial, participants will join different treatment arms to assess IMT's effects. One group will undergo Acute Inspiratory Muscle Training (aIMT), involving a single session guided by a physical therapist. Another group will participate in Daily Inspiratory Muscle Training (dIMT), performing daily exercises for 2-4 weeks before surgery. These findings suggest that both short-term and regular IMT could enhance recovery and ease breathing after orthopedic surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Barbara Smith, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

My health is severely limited by my illness.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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) 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]

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]

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 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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1878124125000383

Inspiratory muscle training: A theoretical framework for its ... IMT can be a promising intervention to enhance recovery in orthopaedic surgery through its ability to strengthen respiratory muscles, improve lung function ...

2. withpower.com withpower.com/trial/phase-joint-diseases-5-2022-d81f7

Inspiratory Muscle Training for Orthopedic Surgery Recovery A study involving 21 elderly patients undergoing inspiratory muscle training (IMT) found that a single short session did not significantly affect heart rate or ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9744751/

Effectiveness and safety of inspiratory muscle training in ... Saglam et al. (17) first reported that IMT can significantly improve inspiratory muscle strength, exercise capacity, dyspnea, and fatigue in PH ...

4. e-arm.org e-arm.org/journal/view.php?number=4404

The Effects of Inspiratory Muscle Training in Individuals With ... The results of the meta-analysis showed that IMT significantly improved maximal inspiratory pressure (MIP) with MD 12.13 cmH2O (95% confidence ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5013088/

Inspiratory muscle training to enhance recovery from ... Two weeks of daily supervised inspiratory muscle training significantly improves inspiratory muscle strength and health-related quality of life ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3293141/

Protocol: inspiratory muscle training for promoting recovery ... In an analysis of 195 IMT treatments in ventilated patients, IMT was found to be safe with zero adverse outcomes and stable physiological ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1036731422000923

Does mechanical threshold inspiratory muscle training ... Primary outcomes were inspiratory muscle strength (maximum inspiratory pressure % predicted) and endurance (fatigue resistance index) at ventilator ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3219341/

Inspiratory muscle strength training improves weaning ... Conclusions. An IMST program can lead to increased MIP and improved weaning outcome in FTW patients compared to SHAM treatment. Trial Registration.

9. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.999422/full

Effectiveness and safety of inspiratory muscle training in ... The pooled results showed a significant increase in MIP in the IMT group compared to the sham/control group (P < 0.001), the mean improvement ...