|- candidate number||28328|
|- NTR Number||NTR6882|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-dec-2017|
|- Secondary IDs||R16.061 MEC-U|
|- Public Title||PREPARE study|
|- Scientific Title||‘Preoperative Exercise Therapy Preventing Postoperative Complications following Complex Abdominal Wall Reconstruction: A Feasibility Study’|
|- hypothesis||Preoperative exercise therapy is feasible in patients before complex abdominal wall reconstruction.|
|- Healt Condition(s) or Problem(s) studied||Physiotherapy, Complex abdominal wall surgery, Prevention|
|- Inclusion criteria||Patients will be included if:|
- Age between 18 and 70
- They have the possibility to execute the training in Helmond.
- There is a midline ventral abdominal wall defect with a diameter of at least 10 centimetre
- The abdominal wall defect must be reconstructed by one of following procedures:
Endoscopic assisted or classic component separation technic (Ramirez plastic), modified Chevrel method, posterior component separation technic*, open ventral hernia repair / Stoppa procedure.
*Only in case of ‘nerve spairing’ component separation (extended Rives-Stoppa with optional Transverse abdominal release).
|- Exclusion criteria||Surgical exclusion criteria:|
- BMI > 35kg/m2 of <20kg/m2
- ASA classification 4 or higher
Intervention exclusion criteria:
- Any co-morbid medical conditions interfering with the ability to perform exercise. (neuromuscular diseases, orthopedic disorders, pulmonic comorbidities, ect.)
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2017|
|- planned closingdate||1-aug-2018|
|- Target number of participants||10|
|- Interventions||The PexT intervention consists of:|
1) Information about the benefits of PexT on the physical capacity and encouragement to adhere to the intervention.
2) Respiratory muscle training
3) Three cardiovascular-, and strength training sessions per week, two supervised, one unsupervised session at home.
The patient receives guides on Active Cycle of Breathing Exercise (ACBEx).
|- Primary outcome||Feasibility
|- Secondary outcome||Health-related quality of life (HRQL)|
Physical capacity (VO2max)
pulmonary complication rate (PCR)
length of hospital stay (LOHS)
|- Timepoints||Time Test|
- Baseline characteristics
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MSc. Elske Berkvens|
|- CONTACT for SCIENTIFIC QUERIES||MSc. Elske Berkvens|
|- Sponsor/Initiator ||Dr. T.S. de Vries Reilingh|
(Source(s) of Monetary or Material Support)
|Dr. T.S. de Vries Reilingh|
|- Brief summary||Rationale: In the past decade, (complex) abdominal wall reconstructions (AWR) are advanced. More patients are eligible for this major elective abdominal wall surgery. The population undergoing an AWR tend to have significant associated, multiple comorbidities, complicating the recovery of a reconstruction. Undergoing AWR exposes these patients to a risk for respiratory complications, which is common after AWR. These complications are associated with an increased surgical morbidity and mortality, prolonged hospital stay, an additional cost burden and indirectly a decrease in quality of life. Improving the physical capacity before surgery, by preoperative exercise therapy (PexT), is likely to give a better recovery and lower complication rate after surgery. In this study, we will survey the feasibility of PexT in patients undergoing an AWR. Outcome measures will be added to demonstrate a possible effect of PexT.|
Objective: Primary: Demonstrate the feasibility of PexT in patients waiting for AWR.
Secondary: Demonstrate a possible effect of PexT in patient waiting for AWR on physical capacity (VO2max) and health-related quality of life (HRQL).
Study design: Feasibility study.
Study population: Patients undergoing an abdominal wall reconstruction.
Intervention: The study group will have PExT, consisting of cardiovascular-, strength and respiratory muscle training, for at least 3 months before surgery.
Main study parameters/endpoints: Primary endpoint is feasibility, based on the participants ability to complete the program and any adverse events or injuries occurred during PexT. Secondary endpoints are VO2max and HRQL.
|- Main changes (audit trail)|
|- RECORD||9-dec-2017 - 27-dec-2017|