Both modalities of IMT will reduce postoperative pulmonary complications and IC stay.
ID
Bron
Aandoening
oesophageal resection, Inspiratory Muscle Training, pulmonary complications
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Postoperative pulmonary complications.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Both modalities of IMT will reduce postoperative pulmonary complications and IC stay.
Onderzoeksopzet
T1= Pre pIMT;
T2 = Post pIMT;
T3 = Post surgery, discharge.
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2781 |
NTR-old | NTR2921 |
Ander register | METC UMCG : ID/ 26588 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |