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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-13

Study Completion Date

2025-10-08

Brief Summary

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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.

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Detailed Description

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INSPIRA is a prospective randomized-controlled single-center trial, non-blinded 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 post-operative complications and their severity grade.

Furthermore, the impact of preoperative inspiratory muscle training on postoperative physiotherapeutic performance as surrogate of convalescence is assessed, too.

Patients will be instructed by physiotherapists to perform inspiratory muscle training containing of 30 breaths twice a day for 14-18 days before surgery using Power®Breathe KHP2.

Primary outcome is Comprehensive Complication Index (CCI) at 90 days after surgery. The CCI expresses morbidity on a con-tinuous numeric scale from 0 (no complication) to 100 (death) by weighing all postoperative complications according to the Clavien-Dindo classification for their respective severity.

Conditions

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Postoperative Complications Breathing Exercises Preoperative Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized-controlled single-center trial, non-blinded

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Training arm

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

Group Type EXPERIMENTAL

preoperative inspiratory muscle training

Intervention Type 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.

Control arm

No preoperative inspiratory muscle training

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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preoperative inspiratory muscle training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)
* Planned surgery at least two weeks after inclusion at outpatient clinic
* Male and female patient over 18 years

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes