NCT00597298

Brief Summary

Diaphragm paralysis is a possible complication of cardiac surgery. The spontaneous recovery of the diaphragm mobility is slow and partial or absent in most cases. We hypothesize that a program of diaphragm muscle training by means of the Threshold variable resistance device could improve the rate of complete diaphragm mobility recovery in a shorter time period. Patient with post-cardiosurgical diaphragm paralysis will be random assigned to the specific training protocol or to a generic non-training physical activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

Enrollment Period

1 year

First QC Date

January 9, 2008

Last Update Submit

February 3, 2009

Conditions

Diaphragmatic Paralysis

Keywords

diaphragmatic paralysiscardiac surgeryrespiratory muscle training

Outcome Measures

Primary Outcomes (1)

  • chest x-ray mobility of the diaphragm

    6 and 12 months

Secondary Outcomes (1)

  • Maximal inspiratory pressure (MIP), cm H2O

    6 and 12 months

Study Arms (2)

1

ACTIVE COMPARATOR

inspiratory muscle training program using a pressure threshold device

Device: Threshold

2

SHAM COMPARATOR
Device: sham threshold

Interventions

ThresholdDEVICE

Inspiratory muscle training program using a variable pressure device. An inspiratory muscle training device comprises a chamber having an opening for the passage of air to be inhaled and exhaled, and an inlet permitting air to be inhaled to enter the chamber and to pass to the opening. A one-way exhaust valve permits exhaled air entering through the opening to escape from the chamber, and another valve is provided to resist the entry of air to be inhaled into the chamber, the latter valve serving to vary the degree of resistance in dependence upon the volume of air that has passed through the inlet.

Also known as: Threshold IMT, Respironics,Cedar Grove NJ, USA, HS730EU-010
1
sham thresholdDEVICE

non-training physical activity

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post-cardiosurgical diaphragmatic paralysis recent cardiosurgical intervention for by-pass and/or valve replacement

You may not qualify if:

  • heart failure
  • COPD
  • neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisiopatologia Respiratoria

Trieste, TS, 34149, Italy

Location

Related Publications (2)

  • Versteegh MI, Braun J, Voigt PG, Bosman DB, Stolk J, Rabe KF, Dion RA. Diaphragm plication in adult patients with diaphragm paralysis leads to long-term improvement of pulmonary function and level of dyspnea. Eur J Cardiothorac Surg. 2007 Sep;32(3):449-56. doi: 10.1016/j.ejcts.2007.05.031. Epub 2007 Jul 19.

    PMID: 17658265BACKGROUND

  • Kodric M, Trevisan R, Torregiani C, Cifaldi R, Longo C, Cantarutti F, Confalonieri M. Inspiratory muscle training for diaphragm dysfunction after cardiac surgery. J Thorac Cardiovasc Surg. 2013 Mar;145(3):819-23. doi: 10.1016/j.jtcvs.2012.07.087. Epub 2012 Aug 29.

    PMID: 22938776DERIVED

MeSH Terms

Conditions

Respiratory Paralysis

Interventions

Speech Reception Threshold Test

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Audiometry, SpeechAudiometryHearing TestsDiagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Maja Demsar, MD

    AOUTS

    STUDY DIRECTOR

  • Marco Confaloniei, MD

    AOUTS

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 18, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

IT(1)