ACTRN12615000841572Not yet recruiting未知
The effect of respiratory muscle training to strengthen the inspiratory muscles after a pleurodesis for malignant pleural effusion
Dr Luke Garske0 sites36 target enrollmentStarted: August 13, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 36
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (—)
- Sex
- All
Inclusion Criteria
- •1. Malignant Pleural Effusion (defined as fluid around lung caused by cancer infiltrating the pleura): diagnosed on basis of (a) pleural fluid cytology or biopsy, or (b) a large exudative pleural effusion with no other cause identified and disseminated extra-thoracic malignancy.
- •2. Participants have undergone a pleurodesis 3 weeks prior to study entry. Pleurodesis may be either surgical (VATS or thoracoscopy) or closed chest tube pleurodesis.
- •3. No significant fluid re-accumulation on clinical assessment 3 weeks after a pleurodesis.
Exclusion Criteria
- •Expected survival < 3 months
- •WHO performance status 3 or 4
- •Body mass index less than 19 or greater than 40
- •Hypoxia requiring long term oxygen therapy
- •Severe cardiac or pulmonary disease causing dyspnea
- •Neurologic disease which may affect respiratory muscle strength, or co-operation with testing
- •Long term steroid therapy
- •Significant chest pain which might interfere with breathing tests and training
- •Pleural tumour greater than 20 mm thickness on CT chest
- •Recent pneumothorax
- •Severe osteoporosis (t score <-3.5), or history of spontaneous rib fractures
- •Rib metastasis
- •Chest wall deformity (kyphoscoliosis)
- •Perforated ear drum or symptoms of eustachian tube insufficiency
- •Language barrier or other significant communication difficulty
- •Women who are pregnant
Investigators
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