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CompletedNCT07931105Updated Nov 12, 2026

Effectiveness of Two Diaphragmatic Strengthening Programs on Symptoms of LPR as Measured by the Reflux Symptom Index (RSI) and the Reflux Disease Questionnaire (RDQ)

An interventional study of Standard abdominal breathing and Resisted Exercise in Laryngeal/Pharyngeal Reflux (LPR), sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled May 2023, registered Nov 2026).
Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 72 studies in Laryngeal Diseases with a site in United States — 15 open to participants now, 17 under way, 3 of them phase 3. Laryngeal Diseases · United States.

Enrollment
17th of 61
69 · median 46
Started
2023
with 1 other
No phase
16 of 72
4 open now
Registered
72nd of 72
by date
Lead sponsor
2 of 72
Mayo Clinic

Among the 72 studies in Laryngeal Diseases with a site in United States, this one is the 17th largest by enrollment of the 61 interventional ones that give a count, is one of 2 that started in 2023, is one of 16 with no phase, and was the 72nd registered.

Laryngeal Diseases

146 studies on the registry are indexed under Laryngeal Diseases; 26 are open to participants now.

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Open to participants now

15 of the 72 studies in Laryngeal Diseases with a site in United States are open now. Recruiting first, the newest first:

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All 15 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 21 Laryngeal Diseases studies recruiting now, 17 (81%) set no upper age limit and 1 (5%) stops at 75 or younger; 3 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The researchers are exploring the effectiveness of a new method of controlling symptoms associated with LPR. Those symptoms may include hoarseness, throat clearing, globus (lump in the throat) sensation, excessive throat mucus, postnasal drip and coughing. Initial studies have been performed that indicate abdominal breathing exercises can reduce symptoms associated with reflux. This may represent a simple and inexpensive means of controlling symptoms associated with a very common disorder. The researchers wish to extend these studies on a set of other reflux-related conditions.

03

Conditions studied

  • Laryngeal/Pharyngeal Reflux (LPR)

Keywords

  • GERD
  • Reflux
  • Diaphragm
  • LPR
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults with complaints of LPR

Exclusion criteria

Exclusion Criteria:

  • Chest or abdominal invasive tubes
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    Standard Abdominal Breathing

    Participants will complete 10 repetitions of abdominal breathing before and after each meal with no resistance.

    Other: Standard abdominal breathing

  • Experimental
    Resisted Exercise

    Participant will complete abdominal breathing 15 minutes per day with resistance applied to the abdomen by the participant.

    Other: Resisted Exercise

Interventions

  • OtherStandard abdominal breathing

    10 repetitions of abdominal breathing before and after each meal with no resistance.

  • OtherResisted Exercise

    Abdominal breathing 15 minutes per day with resistance (participant folds arms across the belly) applied to the abdomen by the participant.

06

What researchers measure

Primary outcomes

  1. Change in Reflux Symptom Index (RSI) Score

    The RSI is a 9-item questionnaire evaluating the severity of nine common LPR-related throat and voice symptoms over the past month. Each symptom is rated from 0 (no problem) to 5 (severe problem), with total scores ranging from 0-45. Higher scores indicate greater laryngopharyngeal reflux symptom severity.

    Time frame: Baseline, 1 month, 3 months, 6 months

  2. Change in Reflux Disease Questionnaire (RDQ) Score

    The RDQ is used to quantify gastroesophageal reflux disease (GERD) symptoms in adults. The RDQ has six symptom items (heartburn, regurgitation, dyspepsia). Each item is rated on two separate 0-5 scales: Frequency (0 = never, 5 = daily) and Severity (0 = did not have, 5 = severe). Each item's frequency + severity sum is averaged across the two items in that symptom dimension, and the overall RDQ score is the mean of all 12 ratings (6 items × 2 facets). Higher scores indicate greater reflux symptom severity.

    Time frame: Baseline, 1 month, 3 months, 6 months

07

Study locations

1 site
  • Mayo Clinic Jacksonville
    Jacksonville, Florida 32224, United States
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in May 2025, 24 months.

Of 28 interventional studies with no phase under Laryngeal Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 24 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 12, 2026
StartActual
May 3, 2023
Primary completionActual
May 7, 2025
CompletionActual
May 7, 2025
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07931105
Lead sponsor
Mayo Clinic
Responsible party
C. Joseph Yelvington P.T., D.P.T. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Nov 12, 2026
Start date
May 3, 2023
Primary completion
May 7, 2025
Completion
May 7, 2025
Last update
Nov 12, 2026

Study contacts

C J. Yelvington, P.T., D.P.T.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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