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Effects of Inspiratory Muscle Training on Exertional Breathlessness in Patients With Unilateral Diaphragm Paralysis

NCT04563468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-01-18

No results posted yet for this study

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).

Conditions

  • Diaphragmatic Paralysis

Interventions

PROCEDURE

Strength inspiratory muscle training

Two training sessions per day consisting of 30 breaths (against external load of \~50% Pi,max; 4-5 minutes per session), 7 days/week (once/month supervised at the research center), for 6 months will be performed using an electronic tapered flow resistive loading (TFRL) device (POWERbreathe®KH1, HaB International Ltd., Southam, UK) according to an established method. Measurements of Pi,max will be performed every week and training loads will be increased continuously to maintain external load at \~50% of Pi,max values. Ratings of perceived inspiratory effort on a modified Borg scale (4-5 out of 10) will also be used to support decisions on increasing training load.

PROCEDURE

Endurance inspiratory muscle training

Two daily sessions of 30 breaths using TFRL device (POWERbreathe®KH1, HaB International Ltd., Southam, UK) and will train at an inspiratory load of no more than 10% of their initial Pi,max. This training load will not be changed during the entire study period. Participants in the control group will be offered the active treatment upon completion of the study.

Sponsors & Collaborators

  • KU Leuven

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-06
Primary Completion
2022-06-13
Completion
2022-06-13

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04563468 on ClinicalTrials.gov