IMT + Biofeedback for Constipation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Miralax

Must not be taking: Opioids, Anticholinergics, Laxatives, others

Disqualifiers: Cardiovascular, Respiratory, Renal, others

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

Compensation: Varies

Number of Visits: 9

Duration: 16 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of biofeedback and Inspiratory Muscle Training (IMT) in treating constipation. The study includes two groups: one will receive both biofeedback and IMT, while the other will receive only biofeedback. Individuals experiencing chronic constipation or irritable bowel syndrome (IBS) with a specific type of difficulty during bowel movements may be suitable for this trial. Participants should be able to attend multiple biofeedback sessions and practice IMT at home. As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative treatments for constipation.

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications to join the trial. If you're using opioids, anticholinergics, or specific laxatives, you must stop them at least 3 days before screening and stay off them during the study. However, you can continue using Miralax throughout the study.

What prior data suggests that these treatments are safe for constipation?

Research shows that Inspiratory Muscle Training (IMT) is generally safe for people. Studies have found that IMT is a safe and well-tolerated treatment for patients with pulmonary hypertension, a type of high blood pressure affecting the lungs. It also aids in strengthening weak breathing muscles. Additionally, IMT can protect against serious issues like muscle weakness and the need for breathing tubes, strengthening breathing muscles without causing harm. Overall, patients widely accept IMT as a safe option for various conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining Inspiratory Muscle Training (IMT) with biofeedback for treating constipation because it targets the condition in a new way. Unlike standard treatments like laxatives or fiber supplements that focus on moving the bowels directly, IMT strengthens the respiratory muscles, which may improve the overall function of the abdominal and pelvic regions. This unique approach could offer a more holistic solution to constipation, potentially providing relief without the side effects commonly associated with traditional medications. Additionally, the incorporation of home-based IMT makes this method more accessible and convenient for patients, potentially leading to better adherence and outcomes.

What evidence suggests that this trial's treatments could be effective for constipation?

Research has shown that Inspiratory Muscle Training (IMT), which participants in this trial may receive, might help with constipation. Studies have found that IMT can improve exercise ability and reduce tiredness, potentially enhancing digestion. Previous research suggests that IMT strengthens the breathing muscles, supporting overall body function and possibly relieving constipation. Additionally, this training can ease breathing while maintaining muscle strength, which is promising for improving health outcomes. These benefits suggest that IMT could effectively manage chronic constipation. ^{6 7 8 9 10}

Who Is on the Research Team?

Adil E. Bharucha, MBBS, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adults aged 18-80 with functional constipation or irritable bowel syndrome, confirmed by questionnaires and anorectal testing showing dyssynergic defecation. Excludes pregnant/nursing women, prisoners, those with significant health issues that could affect the study or pose risks, history of certain colorectal conditions or surgeries, BMI over 35 kg/m2, and users of specific medications unless they can stop use before and during the trial.

Inclusion Criteria

I have been diagnosed with functional constipation or IBS based on specific criteria and tests.

I am between 18 and 80 years old and can follow the study's requirements.

Exclusion Criteria

Any other factors that increase the risk to participants of participating in the study and/or undermine the integrity of the data

Pregnant or nursing women, prisoners and institutionalized individuals

I have a current anal fissure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo biofeedback sessions and inspiratory muscle training

16 weeks

6 to 20 biofeedback sessions, home-based inspiratory muscle training

Follow-up

Participants are monitored for changes in constipation symptoms and quality of life

12 months

3 months post completion, 12 months post completion

What Are the Treatments Tested in This Trial?

Interventions

• Biofeedback
• Inspiratory Muscle Training (IMT)

Trial Overview The trial is investigating two treatments for constipation: Inspiratory Muscle Training (IMT) and Biofeedback. The goal is to understand constipation better and improve biofeedback therapies. Participants will be trained to strengthen their breathing muscles or receive feedback on bodily functions to manage their condition more effectively.

How Is the Trial Designed?

Group I: Biofeedback and inspiratory muscle training (BFT Plus) Experimental Treatment 2 Interventions

Subjects in the BFT Plus arm will participate in a minimum of 6 up to a maximum of 20 biofeedback sessions, with each session lasting approximately 60 minutes. In addition, subjects will engage in inspiratory muscle training (IMT) at home.

Group II: Biofeedback only (BFT Alone) Active Control 1 Intervention

Subjects in the BFT Plus arm will participate in a minimum of 6 up to a maximum of 20 biofeedback sessions, with each session lasting approximately 60 minutes.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05321953

The Impact of Aerobic Interval and Inspiratory Muscle ... The Impact of Aerobic Interval and Inspiratory Muscle Training On Patient Reported Outcome Scores In Individuals With Chronic Constipation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11869749/

The effectiveness of functional inspiratory muscle training on ... F-IMT is more effective in enhancing exercise capacity, reducing fatigue and DBP, and improving MEP. Both IMT and F-IMT show similar benefits.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05321953/the-impact-of-aerobic-interval-and-inspiratory-muscle-training-on-patient-reported-outcome-scores-in-individuals-with-chronic-constipation

The Impact of Aerobic Interval and Inspiratory Muscle ... The Impact of Aerobic Interval and Inspiratory Muscle Training On Patient Reported Outcome Scores In Individuals With Chronic Constipation.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11955241/

The effect of inspiratory muscle training on ... - PubMed Central The results of this systematic review suggest that IMT may increase inspiratory muscle strength and attenuate the inspiratory IMM in healthy ...

5. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2025.1549652/pdf

Effectiveness of inspiratory muscle training in patients with ... These studies have shown that IMT can: (1) decrease the inspiratory muscle motor drive while preserving pressure generation; (15) (2) promote ...

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

Effectiveness and safety of inspiratory muscle training in ... This systematic review and meta-analysis showed that IMT is a safe, feasible, and well-tolerated physical therapy in PH patients. Furthermore, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1036731423000620

Feasibility, safety, and patient acceptability of electronic ... Inspiratory muscle training (IMT) is an intervention that can be used to rehabilitate the respiratory muscle deconditioning experienced by patients with ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05823259/the-impact-of-respiratory-muscle-training-and-patient-education-on-chronic-constipation-outcomes

The Impact of Respiratory Muscle Training and Patient ... The primary aim of this study will be to determine if a respiratory muscle training program that includes both inspiratory muscle training ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5745884/

Safety and efficacy of inspiratory muscle training for ... Inspiratory muscle training was a protective factor against endotracheal intubation, muscle weakness, and mortality. Trial registration.

10. atsjournals.org atsjournals.org/doi/10.1513/AnnalsATS.201712-961OC

Inspiratory Muscle Rehabilitation in Critically Ill Adults. ... IMT has been shown to improve inspiratory muscle strength, exercise performance, or quality of life in patients with chronic obstructive ...