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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21728

Enrollment

Registered

2011-05-27

Start date

2010-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oesophageal resection, Inspiratory Muscle Training, pulmonary complications

Interventions

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 sc

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 be

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Postoperative pulmonary complications.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactE. Weert, van

Postbus 30.002

e.van.weert@rev.umcg.nl+31 (0)50 5338614

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)