Coronary Artery DiseaseHARMONYCRNCT06647212
Harmonica Exercises for Patients Undergoing Cardiac Rehabilitation.
A study testing introducing breathing exercises with the harmonica in people with Coronary Artery Disease and Heart Failure, run by Katarzyna Piotrowicz at 1 site in Poland.
Trial summary
The study aims to assess the effects of exercises using the harmonica on the exercise capacity, the level of depressive symptoms and disease related quality of life in patients suffering from heart disease attending cardiac rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Heart Failure
- What is being tested?
- introducing breathing exercises with the harmonica
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 16 May 2024to 31 May 2025
- 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
- patients participating in cardiac rehabilitation program
Who cannot join
- Decompensated heart failure, with symptoms in NYHA class II-IV within 3 weeks before admission to the Cardiac Rehabilitation Department
- Poorly controlled hypertension (BP in office measurement \>160/100 mmHg)
- Severe symptomatic heart disease (including valvular);
- Other severe comorbidities, including those significantly limiting physical performance: chronic kidney disease with GFR \<30 ml/min/1.73m2 (according to the CKD-EPI formula), severe form of bronchial asthma/chronic obstructive pulmonary disease (stage C/D ), hypertrophic cardiomyopathy, significant cardiac arrhythmias (persistent/permanent atrial fibrillation, sustained supraventricular/ventricular tachycardia, multiple supraventricular/ventricular extrasystole \> 10,000/day), pulmonary embolism in the last 3 months, acute coronary syndrome in the last 7 days, peripheral arterial disease with claudication distance \<200 m, generalized active neoplastic process;
- mental illness/dementia syndrome that prevents full cooperation with the examined person;
- diseases of the musculoskeletal system that make it impossible to perform an exercise test;
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- contraindications to performing an exercise test;
- contact allergy to the materials from which the body/cover of the harmonica is made, revealed during exercises
- lack of consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Poland1 site
Cardiac Rehabilitation Department, Military Institute of Medicine National research Institute
Warsaw, 04-411
About this study
Official title: The Effect of Harmonica Exercises on Cardiorespiratory Exercise Capacity Parameters, Quality of Life and Symptoms of Depression in Patients Undergoing Cardiac Rehabilitation.
The study aims to assess the effects of exercises using the harmonica on the exercise capacity, the level of depressive symptoms and disease related quality of life in patients suffering from heart disease attending cardiac rehabilitation program.
The main questions it aims to answer are:
Read more
Does harmonica exercise improve exercise capacity in patints with herat disease? Does harmonica exercise affect depression levels and health-related quality of life in patients with heart disease?
Researchers will explore the effect of harmonica exercise on exercise capacity and selected psychological aspects of patients participating in cardiac rehabilitation program
Participants will:
Complete a cardiac rehabilitation program with assessment of exercise capacity at the beginning and end of the program Perform breathing exercises only or breathing exercises and harmonica exercises Keep a diary of their exercises
Read the detailed description
The project concerns patients with heart diseases participating in a hybrid cardiac rehabilitation program. The hybrid cardiac rehabilitation program takes place in two periods: an initial hospital stay and a main period at home. The initial period allows for the optimization of pharmacotherapy, performing necessary laboratory tests, performing assessment of exercise capacity , planning and conducting training sessions, education focuses on pro-healty behaviours and psychological counseling. The main period is carried out at home and consists of systematic physical training carried out under the supervision of medical personnel.
As part of the effects of cardiac rehabilitation, it is recommended to perform endurance training appropriate to the patient\&#39;s clinical condition, elements of resistance training and a set of general exercises: including breathing, relaxation, stretching, balance and agility exercises. Breathing exercises are used to improve breathing efficiency and increase the capacity of the respiratory system. The exercises can be performed in a static form, when the patient inhales and exhales in a specific respiratory path, and in a dynamic form, when breathing exercises are combined with movements of the limbs or torso. The training is performed 3-5 times a week for a minimum of 8 weeks, duration is approximately 20-30 minutes. Exercises on the harmonica consist of repeatedly overcoming the very small respiratory resistance created by the instrument during inhalation and exhalation, which results in the generated sound. Therefore - unlike most other wind instruments, which have an adverse effect on the respiratory system - the harmonica was used in exercises for patients with significant respiratory diseases. In the available literature, there are no studies on the use of the harmonica in patients with heart diseases.
One of the most serious and widespread problems of patients with cardiovascular diseases is reduced quality of life and symptoms of depression. Therapy or rehabilitation using music can improve the mental state, sense of self-efficacy and sense of bond with other people, especially among people with symptoms of mood disorders, PTSD or substance abuse. There are no studies on the effect of musical interventions (e.g. using a harmonica) on the somatic and emotional state of people after cardiovascular incidents.
The harmonica exercises were developed by a professional musician, music educator and health sociologist. Duration of a single exercise session: 30 +/- 10 minutes. During the hospital stage, patients will have three lessons with musicians and will receive materials for home exercises. Online communication with musicians will also be possible, in case of doubts about the exercises. Harmonicas used in the study: standard diatonic harmonicas. Principle of exercises: chord playing based primarily on playing rhythms, not melodies, which is the equivalent of exercises for people starting to learn to play the diatonic harmonica.
Patients will receive diaries describing the recommended breathing exercises for the control group and additionally exercises with the harmonica for the study group. In both groups, patients record the amount and time of exercises. After the completion of the rehabilitation cycle, 4-5 weeks, an assessment of the patient\&#39;s exercise capacity and psychological state will be performed, oriented to refer to the project\&#39;s goal.
Study type: prospective, randomized, open clinical trial (with a control group) involving patients admitted to a rehabilitation program who express informed consent to participate in the study. Selection to the study or control group will be randomized, after the participant expresses consent to participate.
Study group: patients randomized to the study group were given a breathing exercise program using a standard diatonic mouth harmonica as the only additional element added to the rehabilitation program Control group: patients following standard rehabilitation program Methods: baseline clinical and laboratory data will be collected. To assess physical exercise capacity fallowing will be performed: cardiopulmonary exercise stress test, 6-minute walk test. To assess psychological status the self-reported questionnaires: EQ-5D/ VAS, Brief IPQ-R and PHQ-9 will be administered.
Data collection: The measurements will be taken at randomization and follow-up (the end of rehabilitation cycle).
- Conditions
- Coronary Artery Disease, Heart Failure
- Being tested
- introducing breathing exercises with the harmonica
- Keywords
- cardiac rehabilitation, harmonica exercises, exercise capacity, quality of life, depression
- Medical subject headings
- Coronary Artery Disease, Heart Failure, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
introducing breathing exercises with the harmonicaOther
In addition to regular breathing exercises, participants will perform harmonica exercises
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | patients randomized to the study arm will receive a breathing exercise program with standard diatonic mouth harmonica Receives: Other: introducing breathing exercises with the harmonica |
| control arm | No intervention | patients randomized to the control arm will follow standard cardiac rehabilitation program with breathing exercises only |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity
Exercise capacity assessed by cardiopulmonary exercise testing measured by peak oxygen consumption.
Measured: from enrollment to the end of cardiac rehabilitataion at 5 weeks
health related quality of life
Health related quality of life measured by the EuroQOL five dimensions questionnaire.This is a self-reported description of the subject's current health in 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Measured: from enrollment to the end of cardiac rehabilitataion program at 5 weeks
symptoms of depression
Syptoms of depressin measured by Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively
Measured: from enrollment to the end of cardiac rehabilitataion program at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start16 May 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Prospective, randomized, open study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katarzyna Piotrowicz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katarzyna Piotrowicz, Military Institute od Medicine National Research Institute
- Investigators
- Katarzyna Piotrowicz, MD, PhD, MS, Study chair, Military Institute of MedicineAnna Mierzyńska, PhD, MS, Principal investigator, Military Institute of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647212
- Sponsor's protocol ID
- Resolution No.12/24
- Acronym
- HARMONYCR
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Harmonica Exercises on Cardiorespiratory Exercise Capacity Parameters, Quality of Life and Symptoms of Depression in Patients Undergoing Cardiac Rehabilitation.
- ClinicalTrials.gov ID
- NCT06647212
- Acronym / sponsor ID
- HARMONYCR / Resolution No.12/24
- Conditions
- Coronary Artery Disease, Heart Failure
- Keywords
- cardiac rehabilitation, harmonica exercises, exercise capacity, quality of life, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Katarzyna PiotrowiczUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 17 Oct 2024 (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.
The study aims to assess the effects of exercises using the harmonica on the exercise capacity, the level of depressive symptoms and disease related quality of life in patients suffering from heart disease attending cardiac rehabilitation program.
The main questions it aims to answer are:
Does harmonica exercise improve exercise capacity in patints with herat disease? Does harmonica exercise affect depression levels and health-related quality of life in patients with heart disease?
Researchers will explore the effect of harmonica exercise on exercise capacity and selected psychological aspects of patients participating in cardiac rehabilitation program
Participants will:
Complete a cardiac rehabilitation program with assessment of exercise capacity at the beginning and end of the program Perform breathing exercises only or breathing exercises and harmonica exercises Keep a diary of their exercises
Detailed description
The project concerns patients with heart diseases participating in a hybrid cardiac rehabilitation program. The hybrid cardiac rehabilitation program takes place in two periods: an initial hospital stay and a main period at home. The initial period allows for the optimization of pharmacotherapy, performing necessary laboratory tests, performing assessment of exercise capacity , planning and conducting training sessions, education focuses on pro-healty behaviours and psychological counseling. The main period is carried out at home and consists of systematic physical training carried out under the supervision of medical personnel.
As part of the effects of cardiac rehabilitation, it is recommended to perform endurance training appropriate to the patient\&#39;s clinical condition, elements of resistance training and a set of general exercises: including breathing, relaxation, stretching, balance and agility exercises. Breathing exercises are used to improve breathing efficiency and increase the capacity of the respiratory system. The exercises can be performed in a static form, when the patient inhales and exhales in a specific respiratory path, and in a dynamic form, when breathing exercises are combined with movements of the limbs or torso. The training is performed 3-5 times a week for a minimum of 8 weeks, duration is approximately 20-30 minutes. Exercises on the harmonica consist of repeatedly overcoming the very small respiratory resistance created by the instrument during inhalation and exhalation, which results in the generated sound. Therefore - unlike most other wind instruments, which have an adverse effect on the respiratory system - the harmonica was used in exercises for patients with significant respiratory diseases. In the available literature, there are no studies on the use of the harmonica in patients with heart diseases.
One of the most serious and widespread problems of patients with cardiovascular diseases is reduced quality of life and symptoms of depression. Therapy or rehabilitation using music can improve the mental state, sense of self-efficacy and sense of bond with other people, especially among people with symptoms of mood disorders, PTSD or substance abuse. There are no studies on the effect of musical interventions (e.g. using a harmonica) on the somatic and emotional state of people after cardiovascular incidents.
The harmonica exercises were developed by a professional musician, music educator and health sociologist. Duration of a single exercise session: 30 +/- 10 minutes. During the hospital stage, patients will have three lessons with musicians and will receive materials for home exercises. Online communication with musicians will also be possible, in case of doubts about the exercises. Harmonicas used in the study: standard diatonic harmonicas. Principle of exercises: chord playing based primarily on playing rhythms, not melodies, which is the equivalent of exercises for people starting to learn to play the diatonic harmonica.
Patients will receive diaries describing the recommended breathing exercises for the control group and additionally exercises with the harmonica for the study group. In both groups, patients record the amount and time of exercises. After the completion of the rehabilitation cycle, 4-5 weeks, an assessment of the patient\&#39;s exercise capacity and psychological state will be performed, oriented to refer to the project\&#39;s goal.
Study type: prospective, randomized, open clinical trial (with a control group) involving patients admitted to a rehabilitation program who express informed consent to participate in the study. Selection to the study or control group will be randomized, after the participant expresses consent to participate.
Study group: patients randomized to the study group were given a breathing exercise program using a standard diatonic mouth harmonica as the only additional element added to the rehabilitation program Control group: patients following standard rehabilitation program Methods: baseline clinical and laboratory data will be collected. To assess physical exercise capacity fallowing will be performed: cardiopulmonary exercise stress test, 6-minute walk test. To assess psychological status the self-reported questionnaires: EQ-5D/ VAS, Brief IPQ-R and PHQ-9 will be administered.
Data collection: The measurements will be taken at randomization and follow-up (the end of rehabilitation cycle).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open study
| Arm | Type | Receives |
|---|---|---|
| study arm | Experimental | Other: introducing breathing exercises with the harmonicapatients randomized to the study arm will receive a breathing exercise program with standard diatonic mouth harmonica |
| control arm | No intervention | –patients randomized to the control arm will follow standard cardiac rehabilitation program with breathing exercises only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients participating in cardiac rehabilitation program
Key exclusion criteria (9 listed)
- Decompensated heart failure, with symptoms in NYHA class II-IV within 3 weeks before admission to the Cardiac Rehabilitation Department
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 |
|---|---|---|
| introducing breathing exercises with the harmonicaIn addition to regular breathing exercises, participants will perform harmonica exercises | Other | study arm |
Primary outcome
exercise capacity
Time frame: from enrollment to the end of cardiac rehabilitataion at 5 weeks
Exercise capacity assessed by cardiopulmonary exercise testing measured by peak oxygen consumption.
health related quality of life
Time frame: from enrollment to the end of cardiac rehabilitataion program at 5 weeks
Health related quality of life measured by the EuroQOL five dimensions questionnaire.This is a self-reported description of the subject's current health in 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression
symptoms of depression
Time frame: from enrollment to the end of cardiac rehabilitataion program at 5 weeks
Syptoms of depressin measured by Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- 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.
Katarzyna Piotrowicz, MD, PhD, MS study chair
Military Institute of Medicine
Anna Mierzyńska, PhD, MS principal investigator
Military Institute of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing introducing breathing exercises with the harmonica in people with Coronary Artery Disease and Heart Failure, run by Katarzyna Piotrowicz at 1 site in Poland.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 Oct 2024. 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 Poland. 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?
Results are not available in the source record.
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?
exercise capacity (time frame: from enrollment to the end of cardiac rehabilitataion at 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2024.