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Impact of a Structural Phonation Training on Respiratory Muscle Function in Patients With Structural Heart Disease

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ClinicalTrials.gov Identifier: NCT03297918
Recruitment Status : Completed
First Posted : September 29, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
Most patients with complex congenital heart disease and cardiomyopathy from acquired heart disease have reduced exercise capacity. Exercise capacity is associated with respiratory muscle strength and function. If structured respiratory muscle training positively influences respiratory muscle function in patients with structural heart disease is not well known. The aim of this study is to investigate whether regular singing lessons and breathing exercises improve respiratory muscle strength in patients with congenital or acquired structural heart disease.

Condition or disease Intervention/treatment Phase
Heart Failure Congenital Heart Disease Behavioral: Respiratory muscle training Not Applicable

Detailed Description:

Most patients with complex congenital heart disease and cardiomyopathy from acquired heart disease have reduced exercise capacity (VO2 max). Furthermore, exercise capacity is associated with respiratory muscle strength and function (maximal inspiratory (MIP) and maximal respiratory (MEP) pressures. If structured respiratory muscle training positively influences respiratory muscle function in patients with complex congenital heart disease or cardiomyopathy from acquired heart disease is not well known.

Aim: The aim of this study is to investigate the influence of a structured phonation and respiratory training with regular singing lessons on respiratory muscle strength and function (MIP and MEP), exercise capacity (VO2 max), NT-proBNP and quality of life.

This is an interventional, single-centre, randomized study. Patients will be recruited from the heart failure and congenital heart disease clinic of the University hospital Basel. Patients will be asked to participate in a structured phonation and respiratory muscle training for 12 weeks. The structured phonation and respiratory muscle training includes weekly singing lessons in a choir, held by a professional instructor, with additional instructions for daily respiratory muscle strength training at home. Respiratory muscle function (MIP and MEP), exercise capacity (VO2max) and quality of life will be measured at the beginning of the intervention and after 12 weeks of interventional training. In parallel, respiratory muscle function, exercise capacity, NT-proBNP and quality of life will be measured in a gender and age matched group of patients without performing the intervention and in a healthy control group who co-participate the choir lessons and the respiratory muscle training. Primary endpoint is the change of maximal inspiratory pressures (MIP) between patients with and without a structured phonation and respiratory muscle training. Secondary endpoints are changes of MEP, VO2max, NT-proBNP and quality of life between patients with and without the intervention; changes of all measured variables between patients and the healthy control group, and changes of all measured variables before and after the intervention in patients. Inclusion criteria: Patients >18 years with known cardiomyopathy from acquired heart disease (ischemic or dilated) or complex forms of congenital heart disease. Exclusion criteria: Acute coronary syndrome ≤6 months or heart failure hospitalization ≤12 months.

Structural singing lesions and respiratory muscle function training may improve respiratory muscle strength, exercise capacity and quality of life in patients with heart failure or complex congenital heart disease. The intervention comes at low costs, can be applied by most of the patients and is feasible even for disabled patients who are not able to participate in regular exercise training. Furthermore, singing may improve respiratory muscle strength and exercise capacity even in the healthy population.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Interventional, single-center, randomised clinical trial
Masking: Single (Participant)
Masking Description: randomised
Primary Purpose: Treatment
Official Title: Impact of a Structural Phonation Training on Respiratory Muscle Function in Patients With Structural Heart Disease - HeartChoir
Actual Study Start Date : February 15, 2018
Actual Primary Completion Date : August 18, 2018
Actual Study Completion Date : October 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Active Comparator: Intervention group
Patients will be asked to participate in a structured singing and respiratory training for 12 weeks.
Behavioral: Respiratory muscle training
The intervention is two-parted and includes weekly singing lessons in a choir, held by a professional instructor, with additional instructions for daily breathing exercise at home.

No Intervention: Control group
no intervention



Primary Outcome Measures :
  1. Maximal inspiratory pressure in kilopascal [ Time Frame: 12 weeks ]
    Change of maximal inspiratory pressure after the intervention


Secondary Outcome Measures :
  1. Change of MEP [ Time Frame: 12 wees ]
    Change of maximal expiratory pressure after the intervention

  2. Change of MVO2 [ Time Frame: 12 weeks ]
    Change of maximal VO2 after the intervention

  3. Change of QoL [ Time Frame: 12 weeks ]
    Change of Quality of life

  4. NT-proBNP [ Time Frame: 12 weeks ]
    Change of Level of NT-proBNP after the intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • age ≥ 18 years
  • known cardiomyopathy from acquired heart disease (ischemic or dilated) or patients with complex CHD (cyanotic congenital heart disease, Fontan palliation, subaortic right ventricle or repaired tetralogy of Fallot)

Exclusion Criteria:

  • Acute coronary syndrome, cardiac surgery or heart failure hospitalization within the previous 6 months
  • chronic metabolic, orthopedic, or infectious disease; treatment with steroids, hormones, or cancer chemotherapy
  • severe exercise-induced asthma
  • professional singer or professionally performing a wind instrument
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297918


Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Daniel Tobler, MD University Hospital, Basel, Switzerland

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03297918     History of Changes
Other Study ID Numbers: HeartChoir
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases