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

NCT04563468 | Completed

• 1 other identifier: S60754
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diaphragm; paralysis; dysfunction; unilateral; phrenic nerve; dyspnea

Outcome Measures

Primary Outcomes (1)

• Dyspnea BORG category ratio 10 scale (scores from 1 to 10; higher score = worse outcome = more dyspnea)

  Difference in dyspnea intensity perception on a 10-point Borg scale at comparable time points during constant work rate cycling exercise pre-post intervention between groups.

  pre-post 6 months intervention

Secondary Outcomes (11)

• Respiratory muscle function

  pre-post 6 months intervention and during every supervised IMT session in the hospital

• Phrenic nerve conduction

  pre-post 6 months intervention

• Maximal end endurance exercise capacity

  pre-post 6 months intervention

• Respiratory effort and neural respiratory drive to the diaphragm

  pre-post 6 months intervention

• Neural respiratory drive to breathing muscles

  pre-post 6 months intervention

Study Arms (2)

Strength inspiratory muscle training group

EXPERIMENTAL

Strength IMT

Procedure: Strength inspiratory muscle training

Endurance inspiratory muscle training group

SHAM COMPARATOR

Endurance IMT

Procedure: Endurance inspiratory muscle training

Interventions

Strength inspiratory muscle training PROCEDURE

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.

Strength inspiratory muscle training group

Endurance inspiratory muscle training PROCEDURE

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.

Endurance inspiratory muscle training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Respiratory Paralysis; Paralysis; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Treatment with inspiratory muscle training will be presented to both groups of patients as active interventions (intentional deception) to increase compliance. Participants in the intervention group will be informed that they are performing a 'strength training' while participants in the control group that they are performing an 'endurance training'. Participants in the control group will be offered the active treatment upon completion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. PT

Model Details: Single blind, parallel group RCT with 2:1 allocation ratio

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 24, 2020
• Study Start: January 6, 2018
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

BE (1)