Peritoneal Metastases
Conditions
Brief summary
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.
Interventions
DEVICEInspiratory muscle training
DEVICEMini-PEP
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of preoperative inspiratory muscle training | The different outcome measures are assessed continuously during a period from inclusion until discharge from the hospital. This period varied in length (3 weeks-3 months) depending on when participants were scheduled for surgery. | Feasibility will be assessed using two domains: process and scientific feasibility. These domains include several parts such as recruitment rates, time available for training, intervention adherence, patient acceptability, pre-and postoperative respiratory muscle and lung function assessments, reproducibility of assessments, preliminary treatment effect, incidence of PPCs, and adverse events. |
Outcome results
None listed