Cancer of Esophagus, Cancer of the Esophagus, Esophageal Cancer, Esophagus Cancer, Esophagus Neoplasm, Neoplasms, Esophageal
Conditions
Keywords
Rehabilitation, Inspiratory Muscle Training
Brief summary
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.
Interventions
BEHAVIORALInspiratory Muscle Training-Rehabilitation
The training will include the following components: 1. Breathing Awareness 2. Upper and Lower Extremity Exercise. 3. Instructions for Inspiratory Muscle Training (IMT) performed using the PFlex valve 4. Practice at home
OTHERQuestionnaires
Patient quality of life will be measured using patient-reported outcomes measurement information system (PROMIS) global items. Patients will also complete the Chronic Respiratory Questionnaire (CRQ) and the Medical Research Council Dyspnea Scale (MCR).
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pneumonia | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pulmonary Complications | 3 months | To prospectively determine the effect of a customized preoperative inspiratory muscle training (IMT) and brief pulmonary rehabilitation program on the incidence of postoperative pulmonary complications in patients that undergo an esophageal surgical resection.The investigators will consider the following events as post-operative pulmonary complications: severe atelectasis (requiring bronchoscopy) and respiratory failure (intubation or prolonged mechanical ventilation (\>24hours). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | 3 months | Length of hospital stay will be measured by participant monitoring while hospitalized until hospital discharge. |
| Quality of Life | Baseline to 3 months | Quality of life will be assessed at baseline and at 3 months after hospital discharge by participant completion of the PROMIS Global 10. |
Countries
United States
Outcome results
None listed