Clinical trial · Interventional
Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
A Pilot Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
NCT02843750CI-TRIAL-00025158withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty recruiting patients
Summary
Brief summary (as posted)
To obtain definitive evidence for the effectiveness of a short preoperative inspiratory muscle training (IMT) protocol on the morbidity and recovery from an esophageal surgical resection.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Esophagus | Malignant Esophageal Neoplasm | ALIAS | 0.90 |
| Cancer of the Esophagus | Malignant Esophageal Neoplasm | ALIAS | 0.90 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophagus Cancer | — | UNRESOLVED | — |
| Esophagus Neoplasm | Esophageal Neoplasm | ALIAS | 0.90 |
| Neoplasms, Esophageal | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inspiratory Muscle Training-Rehabilitation | Behavioral | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Inspiratory Muscle Training-Rehabilitation
- description
- Patients will start the IMT-R, following their consent and within 2 weeks of their scheduled surgery: 10 sessions lasting about 90 minutes. Participants who completed their initial IMT greater than 2 weeks prior to surgery will have an additional visit prior to surgery. Participants will receive a Participant Manual demonstrating and explaining the rehabilitation process. Participants will also receive a log for recording their efforts and notes. A DVD of the rehabilitation is available to the participant. Participants will complete questionnaires at baseline and 3 months.
- interventionNames
- Behavioral: Inspiratory Muscle Training-Rehabilitation
- Other: Questionnaires
Primary outcomes (1)
- measure
- Postoperative Pneumonia
- timeFrame
- 3 months
- description
- To prospectively determine the effect of a customized preoperative inspiratory muscle training (IMT) and brief pulmonary rehabilitation program on the incidence of postoperative pneumonia in patients that undergo an esophageal surgical resection. The investigators will consider the following as pneumonia: new infiltrate + either fever (\>38.5 C) and white cell count \>11,000 or fever and purulent secretions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * All patients diagnosed with esophageal cancer and scheduled for esophageal resection at the Mayo Clinic Rochester with gastric conduit reconstruction -Cognitively capable to understand and perform a preoperative program * Able to follow the intervention program for at least 2 weeks before surgery (surgery is usually scheduled 4 to 12 weeks after radiation) * Willing to sign the informed consent form Exclusion Criteria: * Unable to communicate in the English language * Participating in a conflicting trial concerning esophageal resection
References
Publications (0)
Data not yet available
No reference posted for this study.