Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases

Uppsala University

Status: Completed

Conditions: Peritoneal Metastases

Treatments: Device: Inspiratory muscle training; Device: Mini-PEP

Study type: Interventional

Funder types: Other

Identifiers

NCT05665257

Ethical approval no 2016/338

Details and patient eligibility

About

The goal of this randomized controlled feasibility study was to evaluate the feasibility of preoperative inspiratory muscle training in patients undergoing surgery because of peritoneal metastases.

The main questions it aimed to answer was how feasible the intervention is regarding process and scientific feasibility as defined by Thabane et al 2010.

Participants in the intervention group were using a handheld device to increase their inspiratory muscle strength prior to surgery and researchers compared this group to a control group who were offered a sham treatment.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Exclusion criteria

• Surgery scheduled less than two weeks from the date of inclusion
• Inability to speak and understand Swedish

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Inspiratory muscle training

Experimental group

Description:

Participants in the intervention group were using a handheld device, Powerbreathe K3, aiming at increasing inspiratory muscle strength by applying an inspiratory resistance. They were instructed to use it twice a day for at least 14 days. Starting load was based on the baseline assessment of the participant's inspiratory muscle strength and increased during the intervention period.

Treatment:

Device: Inspiratory muscle training

Mini-PEP

Sham Comparator group

Description:

Participants in the control arm were instructed to use a handheld PEP-device traditionally used to facilitate deep breathing. The PEP-device does not provide any inspiratory resistance and therefore, it was considered a sham treatment. The control group were also instructed to use the device twice a day for at least two weeks.

Treatment:

Device: Mini-PEP