Preliminary effectiveness and feasibility of two pre-operative Inspiratory Muscle Training (IMT) interventions in patients undergoing oesophageal resectio

• Conditions: Pulmonary infections after oesophagal resection; 10017991; 10024970; 10017998

• Registration Number: NL-OMON33515
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Patients selected for oesophagal resection due to cancer

Exclusion Criteria

•Neuromuscular disorders that might impede the performance and effects of muscle training
•Paresis of facial nerve that might impair the use of the IMT-device
•Inability of travelling independently to the rehabilitation centre
•Cognitive disorder or emotional instability that might impede the participation in the rehabilitation program
•Participation in any other clinical trial that measures quality of life or physical functions (exception: follow-up evaluation of clinical trials)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>•% pulmonary postoperative complications (i.e. atelectases, pneumonia,<br /><br>pulmonary oedema and respiratory failure, see appendix I) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Maximal inspiratory muscle strength and endurance (Pi max and Pm-peak/Pimax)<br /><br>- % compliance and % adherence rate<br /><br>- Dyspnoea and muscle fatigue (Borg)<br /><br>- Duration of mechanical ventialtion<br /><br>- Number of re-intubations<br /><br>- Diaphragm function<br /><br>- Lung volumes/oxygen uptake, gas exchange<br /><br>- Self-efficacy (ALCOS)<br /><br>- Anxiety (STAY-DI)<br /><br>- Pain (Visual Analogue Scale), dyspnea an muscle fatigue (Borg)<br /><br>- Complications/adverse events </p><br>