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Developing Protocol for Strengthening the Inspiratory Muscles of Cancer Patients After a Procedure to Prevent Fluid Re-Accumulating in the Chest

Acceptability and Feasibility of an Individualised Inspiratory Muscle Threshold Load Training Protocol after Intervention to control Malignant Pleural Effusion (RMT-MPE)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000917437
Acronym
RMT-MPE
Enrollment
5
Registered
2025-08-22
Start date
2025-08-19
Completion date
2027-06-30
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

This project aims to determine whether a 6 week respiratory muscle training (RMT) program is a well-tolerated, feasible and acceptable intervention in patients with malignant pleural effusion (MPE) after undergoing respiratory procedures. Who is it for? You may be eligible for this study if you are an adult with an MPE requiring definitive intervention (talc pleurodesis or indwelling pleural catheter). Study details Participants will be given a Power Breathe Plus RMT device and receive training from physiotherapists so they know how to use this. They then commence a 6-week training program involving 30 rapid inspired deep breaths through the Power Breathe Plus RMT device, repeated twice daily. The pressure that they are breathing against will be gradually increased by the physiotherapist during regular telehealth follow-up, in an individualised manner. It is hoped that findings from this study help develop this RMT program for use in patients with MPE.

Interventions

A 6-week individualised respiratory muscle training (RMT) program to be completed at the participant's home. This involves participants completing 30 rapid inspired deep breaths through an assigned breathing device, repeated twice daily. The device is a Power Breathe Plus RMT device, which is an inspiratory muscle breathing trainer designed to strengthen inspiratory muscles and improve breathing stamina. Participants will attend the study site to meet a physiotherapist on 3 occasions, allowin

A 6-week individualised respiratory muscle training (RMT) program to be completed at the participant's home. This involves participants completing 30 rapid inspired deep breaths through an assigned breathing device, repeated twice daily. The device is a Power Breathe Plus RMT device, which is an inspiratory muscle breathing trainer designed to strengthen inspiratory muscles and improve breathing stamina. Participants will attend the study site to meet a physiotherapist on 3 occasions, allowing 60 minutes per visit. Visit 1 will be 2 weeks after the participant’s procedure and will include a test of inspiratory muscle strength, completion of questionnaires and a demonstration of how to use the device. This visit will also involve the initial breathing training session to allow this to be supervised by the physiotherapist. Training load will commence at 40% of inspiratory muscle strength (adjusted by physiotherapist for tolerance during initial supervised training). Threshold load of Power Breathe Plus will be increased by 2.5 cms H2O up to three times per week if all of the following are met: • Able to complete 30 rapid, deep breaths within approximately 7 minutes. •Rating Perceived Exertion (RPE) score recorded by participant in study diary is less than 13 out of 20 (“somewhat hard”) at end of 30 breaths. •No moderate/severe chest muscle discomfort caused by training. Each training session will take less than 7 minutes and include 1 minute rest periods after each set of 10 breaths (3 sets in total). Participants to then complete breathing training to suit their schedule with at least 6 hours between sessions. Participants will record details about each training session in a diary. A physiotherapist or research nurse will also phone participants during the 6-week training period for monitoring purposes and to discuss comfort of completing the breathing exercises. These phone calls will be as per below: - Twice per week during the first 2 weeks. - Once per week during the final 4 weeks. Visit 2 will be 2 weeks after Visit 1 and will again include a test of inspiratory muscle strength and completion of questionnaires. Another supervised breathing training session will also occur during this Visit. Visit 3 will be 6 weeks after Visit 1 and will again include a test of inspiratory muscle strength and completion of questionnaires. The final supervised breathing training session will also occur during this Visit.

Sponsors

Wesley Research Institute
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

•MPE (pleural biopsy or pleural fluid diagnostic of pleural malignancy, or recurrent exudative pleural effusions with no alternative cause in the setting of histocytologically proven extra-pleural cancer). •Have received TP or IPC aiming to control symptomatic pleural effusion

Exclusion criteria

• Expected survival < 6 months. • WHO performance status 3 or 4. • Age <18 years • Pregnant. •Significant chest pain expected to interfere with breathing training. •Risk of spontaneous rib fractures (e.g. rib metastasis). •Eustachian tube insufficiency or perforated ear drum. •Communication difficulty or neurologic disease preventing co-operation with testing. •Visual impairment.

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 17, 2026