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CompletedNCT03297918Updated Oct 11, 2018

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

An interventional study of Respiratory muscle training in Heart Failure and Congenital Heart Disease, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-11.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure
  • Congenital Heart Disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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,
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Intervention group

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

    Behavioral: Respiratory muscle training

  • No intervention
    Control group

    no intervention

Interventions

  • BehavioralRespiratory 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.

05

What researchers measure

Primary outcomes

  1. Maximal inspiratory pressure in kilopascal

    Change of maximal inspiratory pressure after the intervention

    Time frame: 12 weeks

Secondary outcomes

  1. Change of MEP

    Change of maximal expiratory pressure after the intervention

    Time frame: 12 wees

  2. Change of MVO2

    Change of maximal VO2 after the intervention

    Time frame: 12 weeks

  3. Change of QoL

    Change of Quality of life

    Time frame: 12 weeks

  4. NT-proBNP

    Change of Level of NT-proBNP after the intervention

    Time frame: 12 weeks

06

Study locations

1 site
  • University Hospital Basel
    Basel, 4031, Switzerland
07

References and documents

Publications

  • 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. PubMed 33038262 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03297918
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Sep 29, 2017
Start date
Feb 15, 2018
Primary completion
Aug 18, 2018
Completion
Oct 10, 2018
Last update
Oct 11, 2018

Study contacts

Daniel Tobler, MD
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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