search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Preliminary effectiveness and feasibility of two pre-operative Inspiratory Muscle Training (IMT) interventions in patients undergoing oesophageal resection.


- candidate number9523
- NTR NumberNTR2921
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mei-2011
- Secondary IDsID/ 26588 METC UMCG
- Public TitlePreliminary effectiveness and feasibility of two pre-operative Inspiratory Muscle Training (IMT) interventions in patients undergoing oesophageal resection.
- Scientific TitlePreliminary effectiveness and feasibility of two pre-operative Inspiratory Muscle Training (IMT) interventions in patients undergoing oesophageal resection.
- ACRONYM
- hypothesisBoth modalities of IMT will reduce postoperative pulmonary complications and IC stay.
- Healt Condition(s) or Problem(s) studiedOesophagectomy, Inspiratory Muscle Training, Pulmonary complications
- Inclusion criteria1. 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 criteria1. 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).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2013
- Target number of participants60
- Interventions1. 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.
- Primary outcomePostoperative pulmonary complications.
- Secondary outcome1. 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.
- TimepointsT1= Pre pIMT;
T2 = Post pIMT;
T3 = Post surgery, discharge.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. E. Weert, van
- CONTACT for SCIENTIFIC QUERIESDr. E. Weert, van
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
UMCG Doelmatigheidsfonds
- PublicationsAdrichem EJ van, Meulenbroek RL, Dijkstra PU, Plukker JTM, Groen H, Weert E van. (18-22 september) Barcelona (Spanje). Variation in measurement results of maximal inspiratory muscle strength testing. European Respiratory Society Congress
- Brief summaryObjective:
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.
- Main changes (audit trail)
- RECORD27-mei-2011 - 14-jun-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl