NCT03297918

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable heart-failure

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

First Submitted

Initial submission to the registry

September 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

September 26, 2017

Last Update Submit

October 10, 2018

Conditions

Heart FailureCongenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Maximal inspiratory pressure in kilopascal

    Change of maximal inspiratory pressure after the intervention

    12 weeks

Secondary Outcomes (4)

  • Change of MEP

    12 wees

  • Change of MVO2

    12 weeks

  • Change of QoL

    12 weeks

  • NT-proBNP

    12 weeks

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Behavioral: Respiratory muscle training

Control group

NO INTERVENTION

no intervention

Interventions

Respiratory muscle trainingBEHAVIORAL

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 33038262DERIVED

MeSH Terms

Conditions

Heart FailureHeart Defects, Congenital

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Daniel Tobler, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
randomised
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Interventional, single-center, randomised clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

September 29, 2017

Study Start

February 15, 2018

Primary Completion

August 18, 2018

Study Completion

October 10, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)