An interventional study of Inspiratory muscle training in Postoperative Complications and Procedure, Thoracic Surgical, sponsored by Istanbul University. Recruiting at 3 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-27.
Sponsored by Istanbul University · Not applicable, Interventional, and Prevention
Postoperative pulmonary complications (PPCs) are the most frequent complications occurring in patients undergoing thoracic surgery and they are associated with prolonged hospital stay, decreased survival and expanding medical costs. Implementation of structured and supervised exercise programs including endurance training (ET), respiratory muscle training (RMT) or a combination of both, within the short waiting period before surgery, has been shown to enhance patients' physical fitness, to provide protective effects against PPCs and therefore to spare health care resources by shortening intensive care unit (ICU) and hospital lengths of stay. More recently, a simple intervention consisting in patient's instruction and education about modifiable risk factors, optimal breathing pattern and the impact of physical exercise has emerged as a simple alternative intervention prevent PPCs, although the evidence is inconclusive.
Therefore, the investigators propose a multicentre randomized, open, blinded end point controlled trial testing the hypothesis that preoperative education and instruction focused on breathing exercise and endurance training reduce the occurrence of PPCs in patients undergoing thoracic or abdominal surgery.
Patients with Intermediate-to-high risks factors for PPCs will be randomized on a 1:1 basis into an intervention arm and a usual care arm (Control group). In the Education group, patients will be asked to use a flow resistive device (One set of 30 repetitions, two times a day and to increase their daily physical activities (> 5'000 steps or equivalent) until surgery. Primary study endpoint will be the incidence of PPCs (e.g., atelectasis, pneumonia, respiratory failure) according to the European Perioperative Clinical Outcome definitions. Secondary outcomes will include non-respiratory complications, utilization of hospital resources (e.g., hospital length of stay, ICU admission),and preoperative changes in maximal inspiratory pressure [MIP]. Assuming a rate of 39% PPCs in the controls and a possible reduction to 26% in the intervention group, enrollment of 203 patients per group will provide 80% power with an alpha value of 0.05. Taking into account dropouts (5%) and in-hospital mortality rate (2%), a total of 436 surgical patients will be enrolled.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's planned enrollment of 436 is above the median of 119 across 689 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion Criteria:
Patients who are candidates for thoracic resection surgeries will be advised to stay active and quit smoking.
Patients who are candidates for thoracic resection surgeries will be handed a flow resistive device that helps inspiratory muscle training (2\*30 repetitions a day for 7 days) and will be advised to walk 5000 steps a day.
Behavioral: Inspiratory muscle training
Patients will do inspiratory muscle training via a flow resistive device. Priorly, maximum inspiratory pressure will be measured. Afterwards, the training device will be set to 10% increased value of maximum inspiratory pressure (MIP), and the training will be completed two times and 30 repetitions a day during preoperative 7 days. Meanwhile patients will be advised to walk 5000 steps a day during the intervention period.
Also known as: Walking (5000 steps/day)
The incidence of postoperative pulmonary complications
Postoperative pulmonary complications will be investigated during the postoperative 5 days. These complications are named according to the European Perioperative Clinical Outcome (EPCO) definitions (Respiratory failure, aspiration pneumonitis, pneumonia, ARDS, pneumothorax, atelectasis, bronchospasm)
Time frame: Up to postoperative 5 days
Preoperative MIP change
Maximum inspiratory pressure (MIP) will be measured during the enrollment and the training resistance will be set up according to this value. Once the training completed (after 7 days) another MIP measurement will be made
Time frame: 7 days
Length of stay in hospital
Length of stay will be recorded as "days"
Time frame: Up to 15 days
Visual Analog Scale thoracic rest pain
Patients will be asked to describe their thoracic rest pain in a scale of 0 to 10
Time frame: Up to 5 days
Visual Analog Scale thoracic coughing pain
Patients will be asked to describe their thoracic coughing pain in a scale of 0 to 10
Time frame: Up to 5 days
Visual Analog Scale dyspnea
Patients will be asked to describe their dyspnea in a scale of 0 to 10
Time frame: Up to 5 days
Plan to share: Undecided
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Istanbul University