Heart FailureNCT03297918
Impact of a Structural Phonation Training on Respiratory Muscle Function in Patients With Structural Heart Disease
A study testing Respiratory muscle training in people with Heart Failure and Congenital Heart Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congenital Heart Disease
- What is being tested?
- Respiratory muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Feb 2018to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Structural Phonation Training on Respiratory Muscle Function in Patients With Structural Heart Disease - HeartChoir
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.
- Conditions
- Heart Failure, Congenital Heart Disease
- Being tested
- Respiratory muscle training
- Medical subject headings
- Heart Failure, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Patients will be asked to participate in a structured singing and respiratory training for 12 weeks. Receives: Behavioral: Respiratory muscle training |
| Control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure in kilopascal
Change of maximal inspiratory pressure after the intervention
Measured: 12 weeks
Secondary outcomes (4)
Change of MEP
Change of maximal expiratory pressure after the intervention
Measured: 12 wees
Change of MVO2
Change of maximal VO2 after the intervention
Measured: 12 weeks
Change of QoL
Change of Quality of life
Measured: 12 weeks
NT-proBNP
Change of Level of NT-proBNP after the intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start15 Feb 2018
- Primary completion18 Aug 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, single-center, randomised clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Tobler, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297918
- Sponsor's protocol ID
- HeartChoir
- Status last verified
- Oct 2018
- First submitted
- 26 Sep 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Structural Phonation Training on Respiratory Muscle Function in Patients With Structural Heart Disease - HeartChoir
- ClinicalTrials.gov ID
- NCT03297918
- Acronym / sponsor ID
- HeartChoir
- Conditions
- Heart Failure, Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 18 Aug 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Interventional, single-center, randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Respiratory muscle trainingPatients will be asked to participate in a structured singing and respiratory training for 12 weeks. |
| Control group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory muscle trainingThe 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. | Behavioural | Intervention group |
Primary outcome
Maximal inspiratory pressure in kilopascal
Time frame: 12 weeks
Change of maximal inspiratory pressure after the intervention
4 secondary outcomes
Change of MEP
Time frame: 12 wees
Change of MVO2
Time frame: 12 weeks
Change of QoL
Time frame: 12 weeks
NT-proBNP
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 33038262Ganzoni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Tobler, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory muscle training in people with Heart Failure and Congenital Heart Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure in kilopascal (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03297918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.