Effects of Inspiratory Muscle Training on Exertional Breathlessness in Patients With Unilateral D… (NCT04563468) | Clinical Trial Compass
CompletedNot Applicable
Effects of Inspiratory Muscle Training on Exertional Breathlessness in Patients With Unilateral Diaphragm Paralysis
Belgium15 participantsStarted 2018-01-06
Plain-language summary
Treatment options for unilateral diaphragm paralysis are limited. Diaphragmatic plication via mini thoracotomy is sometimes considered in the University Hospital Leuven if severe symptoms persist for longer than 12 months after initial diagnosis. Preliminary data indicate that daily inspiratory muscle strength and endurance training can lead to increased nondiaphragmatic inspiratory muscle recruitment and help those with symptoms from diaphragmatic paralysis. Randomized controlled trials comparing intervention groups with improvements achieved by natural recovery in the first months after diagnosis are however so far lacking. The objective of the current study is therefore to investigate the effects of daily inspiratory muscle training in the first 6 months following diagnosis of unilateral diaphragmatic paralysis. The investigators hypothesize that respiratory muscle training in symptomatic patients with UDP (in comparison with a control group) will reduce symptoms of exertional dyspnea (primary outcome) and will improve respiratory muscle function (at rest and during exercise) and pulmonary function (sitting and supine).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for UDP patients:
* Stable, symptomatic adult UDP patients (age ≥18 yrs)
* UDP due to presumed neuralgic amyotrophy
* UDP after surgery/anesthesia (as long as there is no trauma/complete section of the phrenic nerves)
* idiopathic UDP
* UDP patients with Baseline Dyspnea Index (BDI) equal or lower than 9 out of 12.
* UDP patients who have reduced Pi,max (\<70% of predicted normal value), reduced vital capacity (\<75% predicted normal value in sitting and more than 15% reduction when performed supine compared to sitting).
Exclusion Criteria for UDP patients:
* underlying cardiac or respiratory disease that explains symptoms of dyspnea
* malignancy (i.e. metastatic lung cancer)
* diagnosed psychiatric or cognitive disorders
* concomitant progressive neurological, neuromuscular, or vestibular disorders
* severe orthopedic problems that have a major impact on performance of functional tests
Healthy adult (age ≥18 yrs) control subjects:
\- recruitement via two methods. First, friends and family of the MSc student involved in this project will be asked to participate. Secondly, posters with information about the study will be displayed in the University hospital Leuven.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dyspnea BORG category ratio 10 scale (scores from 1 to 10; higher score = worse outcome = more dyspnea)