Randomized-controlled Trial of Preoperative Inspiratory Muscle Training on Postoperative Complications (INSPIRA)
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About
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.
Full description
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.
Enrollment
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
134 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Karin Pettersson
Data sourced from clinicaltrials.gov
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