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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether training the muscles used for breathing can lower blood pressure in adults with obesity. Participants will use a handheld device daily for eight weeks. One group will engage in high-resistance inspiratory muscle strength training, while another will use very-low-resistance training for comparison. The trial aims to determine if this breathing exercise effectively manages blood pressure. Suitable candidates have a body mass index (BMI) between 30 and 40 and are otherwise healthy, without major medical conditions like diabetes or severe high blood pressure. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new methods for managing blood pressure.

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 prior data suggests that this inspiratory muscle training is safe for adults with obesity?

Research has shown that high-resistance inspiratory muscle strength training is generally safe. Studies have found that it can improve heart function and lower blood pressure. Participants in past research found the program easy to follow, and no major safety issues were reported.

In one study, people who did this training experienced better blood pressure and stronger breathing. The lack of specific information on side effects suggests they might be rare or mild. This training has been tested in different groups and has been well-tolerated.

Overall, existing data on safety is positive. However, always consult the study team or your doctor to ensure it's right for you. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about inspiratory muscle training for obesity because it offers a unique approach by focusing on strengthening the breathing muscles. Unlike traditional obesity treatments that primarily involve diet changes, exercise, or medications targeting metabolism, this method uses a handheld device to increase breathing resistance, potentially enhancing fat burning and overall fitness. The high-resistance version challenges the muscles more, while the very-low-resistance option serves as a baseline for comparison, allowing researchers to evaluate the effectiveness of increased resistance in this innovative strategy.

What evidence suggests that this trial's treatments could be effective for reducing blood pressure in adults with obesity?

Research has shown that high-resistance breathing exercises, which participants in this trial may receive, can enhance physical ability and breathing muscle strength in individuals with obesity. One study found that this training improved endurance and muscle strength in just six weeks. Another study demonstrated that these exercises lowered resting blood pressure, particularly the systolic pressure, suggesting the training might help control blood pressure in adults with obesity. Although lung function, BMI, and metabolism showed little change, the improvements in muscle strength and blood pressure are promising. Overall, strong evidence supports this method for managing blood pressure in people with obesity. Meanwhile, this trial will also evaluate very-low-resistance inspiratory muscle strength training as a comparator. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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 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 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) 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 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]

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10711597/

Inspiratory muscle training in patients with obesity

Inspiratory muscle training improves physical capacity, inspiratory muscle strength without significant changes in lung function, BMI, and metabolic parameters.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05459636

Inspiratory Muscle Strength Training in Adults With Obesity

Participants will perform high-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9150656/

Time-efficient, high-resistance inspiratory muscle strength ...

Our recent study was the first to assess the efficacy of high-resistance IMST for improving vascular endothelial function in healthy midlife/older adults. We ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1569904819302034

Six-week inspiratory resistance training ameliorates ...

Our results demonstrate that a six-week progressively-programmed IRT was effective to improve endurance capacity and inspiratory muscle strength in obese ...

5.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.121.020980

Time‐Efficient Inspiratory Muscle Strength Training Lowers ...

When performed 5 to 7 days (25–35 total minutes) per week for 6 weeks, reductions in casual (resting) BP, particularly SBP, were observed in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12387955/

Inspiratory Muscle Training Improves Respiratory ...

Reduced respiratory muscle strength in obese people may lead to decreased respiratory efficiency and increase the risk of dyspnea and exercise ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9203907/

Translational Potential of High-Resistance Inspiratory Muscle ...

High-resistance inspiratory muscle strength training (IMST) is a time-efficient lifestyle intervention that may promote adherence and improve CV function.

8.

medrxiv.org

medrxiv.org/content/10.1101/2023.10.27.23297688v1.full

Protocol for the Diabetes Inspiratory Training (DIT) Clinical ...

With just six weeks of training (5 days/week), high resistance-IMST has been shown to lower systolic blood pressure (systolic BP) by ∼9 mmHg in ...