Effect of Acid Reflux on Respiratory Physiology During Exercise in Athletes With GER-Response to Acid Suppression
| Status: | Terminated |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2007 |
| End Date: | September 2009 |
We propose that acid reflux affects respiratory dynamics (breathing) in patients who are
exercising and that athletes improve their exercise capacity with acid suppression therapy.
It is our intent to determine whether treatment of GER with strong acid suppression may
alleviate symptoms, improve exercise capacity, and improve quality of life.
exercising and that athletes improve their exercise capacity with acid suppression therapy.
It is our intent to determine whether treatment of GER with strong acid suppression may
alleviate symptoms, improve exercise capacity, and improve quality of life.
This is a randomized, blinded, cross-over trial. We plan to take athletes with classical
GER, cough, shortness of breath, chest tightness during exercise and subject them to
complete pulmonary function testing in conjunction with exercise and pH testing. We will
assess whether such athletes experience an increase in reflux duration and episodes during
exercise. The athletes will be randomized (in a cross over fashion) to acid suppression (BID
Nexium 40 mg) or placebo for 10-12 weeks. Both the athletes and investigators will be
blinded. After 10-12 weeks, exercise testing (ramp protocol with VO2 and anaerobic
threshold) with concurrent respiratory function testing will be repeated along with symptom
assessment. After a brief washout period of 1-2 weeks, the athletes will then cross-over to
the other study medication for 10-12 weeks. Again, at the end of the study period,
symptomatic relief as well as respiratory function improvement will be assessed by repeating
the initial exercise regimen. The exercise regimens during these medication regimens will
not be held stable as indirectly, as a results of "feeling better or worse" from the
medication/placebo, these patients may increase/ decrease their exercise routine, resulting
in changes in their overall endurance, anaerobic threshold, etc (our endpoints). By keeping
the regimen stable, we do not allow for the changes to occur which are large enough to
detect.
GER, cough, shortness of breath, chest tightness during exercise and subject them to
complete pulmonary function testing in conjunction with exercise and pH testing. We will
assess whether such athletes experience an increase in reflux duration and episodes during
exercise. The athletes will be randomized (in a cross over fashion) to acid suppression (BID
Nexium 40 mg) or placebo for 10-12 weeks. Both the athletes and investigators will be
blinded. After 10-12 weeks, exercise testing (ramp protocol with VO2 and anaerobic
threshold) with concurrent respiratory function testing will be repeated along with symptom
assessment. After a brief washout period of 1-2 weeks, the athletes will then cross-over to
the other study medication for 10-12 weeks. Again, at the end of the study period,
symptomatic relief as well as respiratory function improvement will be assessed by repeating
the initial exercise regimen. The exercise regimens during these medication regimens will
not be held stable as indirectly, as a results of "feeling better or worse" from the
medication/placebo, these patients may increase/ decrease their exercise routine, resulting
in changes in their overall endurance, anaerobic threshold, etc (our endpoints). By keeping
the regimen stable, we do not allow for the changes to occur which are large enough to
detect.
Inclusion Criteria:
- We plan to take athletes (cyclists) with GER (heartburn symptoms on a daily-weekly
basis which are either improved by a trial of acid suppression or objectively
documented via pH/endoscopic testing- this may include during exercise) who
experience one or more of the following symptoms during exercise, limiting their
perceived ability to exercise to full capacity:
- choking
- cough
- wheezing
- shortness of breath
- chest tightness during exercise
- Athletes will be defined as persons who exercise on a routine basis (at least 3 times
a week on average) for at least the past 6 months.
- Subjects must be at least 18 years old.
Exclusion Criteria:
- Pregnancy
- Age less than 18 years or greater than 65 years
- Abnormal methacholine challenge tests will not exclude one from enrollment as (has
been documented in a prior study) often patients with GER will have heightened
bronchial reactivity.
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