No registrations found.
ID
Source
Health condition
oesophageal resection, Inspiratory Muscle Training, pulmonary complications
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative pulmonary complications.
Secondary outcome
1. Maximal inspiratory muscle strength and endurance;
2. Compliance rate;
3. Time to detubation;
4. Number of re-intubations;
5. Duration of IC stay/general ward;
6. Diaphragm function;
7. Lungvolumes;
8. Self-efficacy, anxiety and patient satisfaction.
Background summary
Objective:
To examine the preliminary effectiveness of preoperative IMT high-intensity in patients undergoing oesophagus resection on postoperative pulmonary complications, inspiratory muscle strength/endurance and IC stay compared to preoperative IMT –endurance. Secondary objective is to examine the feasibility (i.e. patient satisfaction, compliance) of preoperative IMT high-intensity in patients undergoing thoracic surgery (for oesophagus resection) compared to preoperative IMT –endurance.
Study design:
Randomized Controlled Trial, with blinded observers.
Study population:
Patients undergoing oesophagus resection, age 18-85 yr.
Intervention:
Both IMT interventions will consist of preoperative, individually tailored breathing exercises during 3 – 6 weeks prior to surgery. The IMT will be given with a Treshold IMT device, which provide a constant, sustained pressure challenge throughout the entire inspiration that is independent of airflow. The IMT endurance training starts at a resistance of 30% of MIP and the patient breathes through the device during 20 minutes. The resistance will be increased with 5%, if the perceived exertion scored on the Borg scale (0-10) is less than 5. The IMT high intensity training starts at 60 % of MIP and contains 6 cycles of 6 inspiratory breathing manoeuvres. The load will be increased to maximal load.
Main study parameters/endpoints:
Postoperative pulmonary complications, maximal inspiratory muscle strength and endurance, compliance rate, duration of IC stay/general ward, lself-efficacy, anxiety and patient satisfaction.
Study objective
Both modalities of IMT will reduce postoperative pulmonary complications and IC stay.
Study design
T1= Pre pIMT;
T2 = Post pIMT;
T3 = Post surgery, discharge.
Intervention
1. The IMT endurance training starts at a resistance of 30% of MIP and the patient breathes through the device during 20 minutes. The resistance will be increased with 5%, if the perceived exertion scored on the Borg scale (0-10) is less than 5;
2. The IMT high intensity training starts at 60 % of MIP and contains 6 cycles of 6 inspiratory breathing manoeuvres. The load will be increased to maximal load.
Both interventies will be provided between 1 and 6 weeks preoperatively.
E. Weert, van
Centre for Rehabilitation
University Medical Centre Groningen
Dilgtweg 5
Haren 9750 ND
The Netherlands
+31 (0)50 5338614
e.van.weert@rev.umcg.nl
E. Weert, van
Centre for Rehabilitation
University Medical Centre Groningen
Dilgtweg 5
Haren 9750 ND
The Netherlands
+31 (0)50 5338614
e.van.weert@rev.umcg.nl
Inclusion criteria
1. Age over 18;
2. Diagnosis of oesophageal cancer and selected for oesophageal resection according to the judgement of the surgeon;
3. Knowledge of the Dutch language.
Exclusion criteria
1. Neuromuscular disorders that might impede the performance and effects of muscle training;
2. Paresis of facial nerve that might impair the use of the IMT-device;
3. Inability to travel independently to the rehabilitation centre;
4. Unstable asthma;
5. History of spontaneous pneumothorax;
6. Cognitive disorder that might impede the participation in the rehabilitation program (for example: subjects who are unable to be instructed, to think in three dimensions, to fill in questionnaires);
7. Emotional instability that is expected to possibly impede the participation in the rehabilitation program (for example getting divorced at the moment, death of a loved one);
8. Participation in any other clinical trial that measures quality of life or physical functions (exception: follow-up evaluation of clinical trials).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2781 |
| NTR-old | NTR2921 |
| Other | METC UMCG : ID/ 26588 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |