Clinical trial NCT06647212: Harmonica Exercises for Patients Undergoing Cardiac Rehabilitation.
Official title: The Effect of Harmonica Exercises on Cardiorespiratory Exercise Capacity Parameters, Quality of Life and Symptoms of Depression in Patients Undergoing Cardiac Rehabilitation.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Heart Failure
Keywords: cardiac rehabilitation
harmonica exercises
exercise capacity
quality of life
depression
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, open study
Primary purpose: TREATMENT

Brief 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.

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\&amp;#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\&amp;#39;s exercise capacity and psychological state will be performed, oriented to refer to the project\&amp;#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).

Eligibility criteria: Inclusion Criteria:

patients participating in cardiac rehabilitation program

Exclusion Criteria:

* 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 \&gt;160/100 mmHg)
  * Severe symptomatic heart disease (including valvular);
  * Other severe comorbidities, including those significantly limiting physical performance: chronic kidney disease with GFR \&lt;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 \&gt; 10,000/day), pulmonary embolism in the last 3 months, acute coronary syndrome in the last 7 days, peripheral arterial disease with claudication distance \&lt;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;
  * 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

Primary outcomes:
measure: exercise capacity
timeFrame: from enrollment to the end of cardiac rehabilitataion at 5 weeks
measure: health related quality of life
timeFrame: from enrollment to the end of cardiac rehabilitataion program at 5 weeks
measure: symptoms of depression
timeFrame: from enrollment to the end of cardiac rehabilitataion program at 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Cardiac Rehabilitation Department, Military Institute of Medicine National research Institute
Study officials:
affiliation: Military Institute of Medicine
name: Katarzyna Piotrowicz, MD, PhD, MS
role: STUDY_CHAIR
affiliation: Military Institute of Medicine
name: Anna Mierzyńska, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: