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

Primary Purpose

Heart Failure, Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Respiratory muscle training
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Patients will be asked to participate in a structured singing and respiratory training for 12 weeks.

no intervention

Outcomes

Primary Outcome Measures

Maximal inspiratory pressure in kilopascal
Change of maximal inspiratory pressure after the intervention

Secondary Outcome Measures

Change of MEP
Change of maximal expiratory pressure after the intervention
Change of MVO2
Change of maximal VO2 after the intervention
Change of QoL
Change of Quality of life
NT-proBNP
Change of Level of NT-proBNP after the intervention

Full Information

First Posted
September 26, 2017
Last Updated
October 10, 2018
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03297918
Brief Title
Impact of a Structural Phonation Training on Respiratory Muscle Function in Patients With Structural Heart Disease
Official Title
Impact of a Structural Phonation Training on Respiratory Muscle Function in Patients With Structural Heart Disease - HeartChoir
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
August 18, 2018 (Actual)
Study Completion Date
October 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congenital Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional, single-center, randomised clinical trial
Masking
Participant
Masking Description
randomised
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Patients will be asked to participate in a structured singing and respiratory training for 12 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Behavioral
Intervention Name(s)
Respiratory muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal inspiratory pressure in kilopascal
Description
Change of maximal inspiratory pressure after the intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change of MEP
Description
Change of maximal expiratory pressure after the intervention
Time Frame
12 wees
Title
Change of MVO2
Description
Change of maximal VO2 after the intervention
Time Frame
12 weeks
Title
Change of QoL
Description
Change of Quality of life
Time Frame
12 weeks
Title
NT-proBNP
Description
Change of Level of NT-proBNP after the intervention
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Tobler, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33038262
Citation
Ganzoni C, Arslani K, Pfister O, Freese M, Strobel W, Mueller C, Tobler D. Choir singing improves respiratory muscle strength and quality of life in patients with structural heart disease - HeartChoir: a randomised clinical trial. Swiss Med Wkly. 2020 Sep 16;150:w20346. doi: 10.4414/smw.2020.20346. eCollection 2020 Sep 7.
Results Reference
derived

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

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