Inspiratory Muscle Training for Obesity

Overseen By Joseph Watso

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Must not be taking: Tobacco, Nicotine

Disqualifiers: Cardiovascular, Neurological, Renal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

44 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow the use of anti-hypertensive medications (medications for high blood pressure).

What data supports the effectiveness of the treatment High-resistance inspiratory muscle strength training for obesity?

Research shows that inspiratory muscle training (IMT) can improve physical performance and reduce breathlessness in adults with obesity, making it easier for them to engage in physical activity. A study found that a 4-week IMT program significantly improved walking performance in overweight and obese adults. ^{1 2 3 4 5}

Is inspiratory muscle training generally safe for humans?

Inspiratory muscle training (IMT) has been widely used in both healthy and diseased populations, including older adults and patients with chronic conditions, and is generally considered safe. ^{1 3 6 7 8}

How is inspiratory muscle training different from other treatments for obesity?

Inspiratory muscle training (IMT) is unique because it focuses on strengthening the muscles used for breathing, which can help reduce breathlessness and improve physical performance in people with obesity. Unlike other treatments that might focus on diet or medication, IMT is a non-intrusive exercise that specifically targets respiratory muscles to enhance overall fitness and encourage more physical activity. ^{1 2 4 6 9}

What is the purpose of this trial?

The purpose of this study is to determine whether inspiratory muscle strength training reduces blood pressure in adults with obesity.

Eligibility Criteria

This trial is for adults with obesity, defined by a body mass index (BMI) between 30 and 40 kg/m2. It's not specified who can't join the trial beyond these criteria.

Inclusion Criteria

My body mass index is between 30 and 40.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform daily high-resistance or very-low-resistance inspiratory muscle strength training for eight weeks

8 weeks

Follow-up

Participants are monitored for changes in blood pressure, exertion, and breathlessness

8 weeks

Treatment Details

Interventions

• High-resistance inspiratory muscle strength training
• Very-low-resistance inspiratory muscle strength training

Trial Overview The study is testing two types of breathing exercises: one with high resistance and another with very low resistance, to see if they can lower blood pressure in obese adults.

Participant Groups

Group I: High-resistance inspiratory muscle strength training Active Control 1 Intervention

Participants will perform high-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in.

Group II: Very-low resistance inspiratory muscle strength training Placebo Group 1 Intervention

Participants will perform very-low-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in.

High-resistance inspiratory muscle strength training is already approved in United States, European Union for the following indications:

Approved in United States as High-Resistance Inspiratory Muscle Strength Training for:

• Lowering blood pressure
• Improving endothelial function

Approved in European Union as High-Resistance Inspiratory Muscle Strength Training for:

• Respiratory rehabilitation
• Improving lung function

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Findings from Research

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]

Inspiratory muscle training (IMT) significantly improved inspiratory muscle strength and walking distance in a group of 67 adults with obesity over a 4-week period, indicating its efficacy as a practical intervention.

The study suggests that IMT can enhance functional fitness in obese adults, potentially leading to increased participation in physical activities, making it a valuable self-administered strategy for home use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of inspiratory muscle training as a practical and minimally intrusive technique to aid functional fitness among adults with obesity. Edwards, AM., Graham, D., Bloxham, S., et al.[2018]

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]

Inspiratory muscle training (IMT) significantly improved inspiratory muscle strength and increased walking distance in a 6-minute walking test for overweight and obese adults, with a notable gain of 62.5 meters after 4 weeks of training.

The study involved 15 participants, and the results suggest that IMT could be a practical and effective preparatory strategy to enhance physical activity in overweight and obese individuals before starting a more intensive training program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four weeks of inspiratory muscle training improves self-paced walking performance in overweight and obese adults: a randomised controlled trial. Edwards, AM., Maguire, GP., Graham, D., et al.[2021]

Inspiratory muscle training (IMT) significantly improved respiratory muscle strength and endurance in collegiate distance runners after 4 weeks of training, as indicated by increased maximal inspiratory mouth pressure (MIP) and breathing endurance time (BET).

Despite these improvements in respiratory function, IMT did not lead to significant changes in overall endurance exercise capacity or maximal oxygen consumption (VO2max) during high-intensity running, suggesting that enhanced respiratory muscle strength does not directly translate to better performance in endurance activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training fails to improve endurance capacity in athletes. Williams, JS., Wongsathikun, J., Boon, SM., et al.[2019]

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]

Inspiratory muscle training (IMT) significantly improves balance in both healthy and diseased adults, based on a systematic review of 10 randomized control trials.

The effects of IMT on functional mobility were inconclusive, indicating that while balance benefits are clear, more research is needed to understand its impact on overall mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. Sheraz, S., Ferraro, FV., Siddiqui, FA., 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) significantly improves inspiratory muscle strength and endurance in morbidly obese patients after bariatric surgery, with a 13% increase in maximum inspiratory pressure (MIP) compared to an 8% decrease in the control group by the 30th postoperative day.

IMT also leads to an earlier recovery of pulmonary function, as evidenced by improved spirometry parameters (FEV1, PEF, and FEF25-75%) in the IMT group, highlighting its efficacy in enhancing respiratory recovery post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of inspiratory muscle training on muscular and pulmonary function after bariatric surgery in obese patients. Casali, CC., Pereira, AP., Martinez, JA., et al.[2021]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of inspiratory muscle training as a practical and minimally intrusive technique to aid functional fitness among adults with obesity. [2018]

3. England pubmed.ncbi.nlm.nih.gov

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

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

Four weeks of inspiratory muscle training improves self-paced walking performance in overweight and obese adults: a randomised controlled trial. [2021]

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

Inspiratory muscle training fails to improve endurance capacity in athletes. [2019]

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

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

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

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. [2023]

8. 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]

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

Effects of inspiratory muscle training on muscular and pulmonary function after bariatric surgery in obese patients. [2021]