Randomized-controlled Trial of Preoperative Inspiratory Muscle Training on Postoperative Complications

NCT04558151 | Completed

• 1 other identifier: 2020-PreopInsp
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

Rehabilitation strategies after abdominal surgery enhance recovery and improve outcome. A cornerstone of rehabilitation is respiratory physiotherapy with inspiratory muscle training to enhance pulmonary function. Prehabilitation is the process of enhancing functional capacity before surgery in order to compensate for the stress of surgery and postoperative recovery. There is growing interest in deploying pre-habilitation interventions prior to surgery. The aim of this study is to assess the impact of preoperative inspiratory muscle training on postoperative overall morbidity. The question is, whether inspiratory muscle training prior to elective abdominal surgery reduces the number of postoperative complications and their severity grade.

Conditions

Preoperative Period; Postoperative Complications; Breathing Exercises

Keywords

inspiratory muscle training; CCI; postoperative complications; prehabilitation; preoperative respiratory training

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  Postoperative complications measured by the comprehensive complication index (CCI) Com-prehensive Complication Index (CCI) 90 days after surgery. The CCI expresses postoperative morbidity on a continuous numeric scale from 0 (no complication) to 100 (death) by weighing all postoperative complications according to the validated Clavien-Dindo classification for their respective severity. It is measured at the end-of hospitalization and 90 days after surgery to include cases in which a readmission was necessary. Postoperative complications are gold standard in evaluation of quality of surgery as they directly reflect the procedures out-come and are most relevant for the patients.

  90 days postoperative

Secondary Outcomes (10)

• Postoperative morbidity

  At the end of hospitalization and 90 days +/- 2 weeks postoperative

• Length of hospital stay (LOS)

  90 days postoperative

• Readmission rate

  90 days postoperative

• Mortality

  90 days postoperative

• Maximum inspiratory pressure (MIP)

  5 days after surgery

Study Arms (2)

Training arm

EXPERIMENTAL

Patients perform inspiratory muscle training containing of 30 breaths twice a day for 14-18 days before surgery.

Behavioral: preoperative inspiratory muscle training

Control arm

NO INTERVENTION

No preoperative inspiratory muscle training

Interventions

preoperative inspiratory muscle training BEHAVIORAL

Physiotherapists will measure the maximal inspiration pressure (MIP) with the POWER®breathe device of each single patient. Patients will then be instructed to perform inspiratory muscle training at the level of 60% of their individual MIP. Patients are instructed to perform the training containing of 30 breaths twice a day for 14-18 days before surgery. The devices are able to register the performance of each single training session and training results are monitored.

Training arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature (Appendix Patient Informed Consent Form)
• Planned abdominal surgery with planned duration \>2hours (disease localization: upper vs. lower gastro intestinal, HPB, hernia, others)
• Male and female patient over 18 years

You may not qualify if:

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, of the participant
• Known or suspected non-compliance, drug or alcohol abuse,
• Previous enrolment into the current study
• Participation in another study with inspiratory muscle training within 30 days preceding or during this study

Sponsors & Collaborators

• Lunge Zuerich: collaborator
• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (1)

• Birrer DL, Kuemmerli C, Obwegeser A, Liebi M, von Felten S, Pettersson K, Horisberger K. INSPIRA: study protocol for a randomized-controlled trial about the effect of spirometry-assisted preoperative inspiratory muscle training on postoperative complications in abdominal surgery. Trials. 2022 Jun 7;23(1):473. doi: 10.1186/s13063-022-06254-4.

  PMID: 35672861 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dominique Lisa Birrer, MD

  UniversitätsSpital Zürich (USZ)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized-controlled single-center trial, non-blinded

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 22, 2020
• Study Start: August 13, 2021
• Primary Completion: October 8, 2025
• Study Completion: October 8, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)