None listed
Conditions
Brief summary
This study will determine the effect of respiratory muscle training on the inspiratory muscles after pleurodesis in cancer patients with malignant pleural effusion. It will assess whether this is a promising therapy to improve clinical outcomes in cancer patients with malignant pleural effusion. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have had a diagnosis of malignant pleural effusion and have had pleurodesis with no significant fluid re-accumulation on clinical assessment 3 weeks after. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive inspiratory muscle strength training twice daily for 6 weeks using a Powerbreathe Medic device. While participants in the other group will perform deep breaths to improve lung capacity using the same device. Participants will perform tests of the strength of the breathing muscles, lung capacity and the oxygen fuel economy of the breathing muscles. An ultrasound test will be performed to check the thickness of the main breathing muscle. Participants will answer questionnaires to compare the effectiveness of the two interventions. If the respiratory muscles can be trained, this may reduce the need for further invasive drainage procedures and/or improve dyspnea.
Interventions
3 weeks after a pleurodesis to control MPE, patients will undergo a single blinded randomized controlled trial.
The intervention arm will receive inspiratory muscle strength training (IMT), requiring patients to take 30 deep forceful breaths (in 5-7 minutes) twice daily for 6 weeks through a Powerbreathe Medic device with an inspiratory threshold load initially set at approximately 40% of Maximum Inspiratory Pressure (MIP) and increased as tolerated.
The Powerbreathe device is a small handheld
3 weeks after a pleurodesis to control MPE, patients will undergo a single blinded randomized controlled trial. The intervention arm will receive inspiratory muscle strength training (IMT), requiring patients to take 30 deep forceful breaths (in 5-7 minutes) twice daily for 6 weeks through a Powerbreathe Medic device with an inspiratory threshold load initially set at approximately 40% of Maximum Inspiratory Pressure (MIP) and increased as tolerated. The Powerbreathe device is a small handheld device held up to the mouth which provides resistance during inhalation. The initial 5-7 minute training session will be supervised by the principal investigator who is a Thoracic Physician, after baseline assessment. 30 minutes instruction on how to use the Powerbreathe Medic will be provided at this time. A 5-7 minute session of training supervised by a Thoracic Physician will be repeated after 2 and 4 weeks of home training. The principal investigator will prescribe increased threshold load each week, by approximately 10% of baseline MIP, after weekly 10 minute phone call. Adherence will be monitored with diaries.
Sponsors
Dr Luke Garske
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
Outcome results
None listed