Harmonica Exercises for Patients Undergoing Cardiac Rehabilitation.

NCT06647212 | Active Not Recruiting

• 1 other identifier: Resolution No.12/24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease; Heart Failure

Keywords

cardiac rehabilitation; harmonica exercises; exercise capacity; quality of life; depression

Outcome Measures

Primary Outcomes (3)

• exercise capacity

  Exercise capacity assessed by cardiopulmonary exercise testing measured by peak oxygen consumption.

  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

  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

  from enrollment to the end of cardiac rehabilitataion program at 5 weeks

Study Arms (2)

study arm

EXPERIMENTAL

patients randomized to the study arm will receive a breathing exercise program with standard diatonic mouth harmonica

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

Interventions

introducing breathing exercises with the harmonica OTHER

In addition to regular breathing exercises, participants will perform harmonica exercises

study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients participating in cardiac rehabilitation program

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Katarzyna Piotrowicz: lead

Study Sites (1)

Cardiac Rehabilitation Department, Military Institute of Medicine National research Institute

Warsaw, 04-411, Poland

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure; Depression

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Study Officials

• Katarzyna Piotrowicz, MD, PhD, MS

  Military Institute of Medicine

  STUDY CHAIR

• Anna Mierzyńska, PhD, MS

  Military Institute of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Cardiac Rehabilitation Department

Model Details: Prospective, randomized, open study

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 17, 2024
• Study Start: May 16, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)