Tests breathing muscle training in adults with heart disease after angioplasty
Tests breathing muscle training added to cardiac rehabilitation in people with narrowed heart arteries.
Plain-language title generated from the registry record
Registry title: Effectiveness of Inspiratory Muscle Training for People With Ischemic Heart Disease Revascularized by Percutaneous Transluminal Coronary Angioplasty.
Key facts
- Where
- Málaga, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with heart disease from narrowed heart arteries who had a coronary angioplasty. It tests adding breathing-muscle training to a cardiac rehabilitation program.
- Age
- Over 18 and under 80 years old (18 Years to 80 Years).
- Sex
- Men and women can both join.
- Disease stage
- People with myocardial ischemia who had a percutaneous transluminal coronary angioplasty.
- Earlier treatment
- Must have had a percutaneous transluminal coronary angioplasty.
Main reasons for not taking part
- A disease or condition that makes exercise unsafe, such as severe hypertrophic obstructive cardiomyopathy
- Severe aortic stenosis and/or dissecting aortic aneurysm
- Memory or thinking problems, or physical limits, that stop exercise or filling in the questionnaires
- Refusing treatment or not signing the informed consent
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06681740, who can take part
Where in Spain
- Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Cadiz
- Trial code
- NCT06681740
- Record updated
- 29 September 2025
- Original description
Myocardial Ischemia (MI) consists of the narrowing of the internal lumen of the arteries that perfuse the heart. As the section of the artery decreases, so does the blood flow and therefore the supply of oxygen to the myocardium, which can cause angina pectoris or even an acute myocardial infarction. It is the leading cause of death from cardiovascular disease, responsible for 9.44 million deaths in 2021 and 185 million disability-adjusted life years. For this reason, it is one of the most important public health problems in all countries in the world that entails high health and social spending.Read full original descriptionShow less
CARDIOINSPIRE - Effectiveness of Adding Inspiratory Muscle Training to a Cardiac Rehabilitation Program for People With Ischemic Heart Disease Revascularized by Percutaneous Transluminal Coronary Angioplasty.
Myocardial Ischemia (MI) consists of the narrowing of the internal lumen of the arteries that perfuse the heart. As the section of the artery decreases, so does the blood flow and therefore the supply of oxygen to the myocardium, which can cause angina pectoris or even an acute myocardial infarction. It is the leading cause of death from cardiovascular disease, responsible for 9.44 million deaths in 2021 and 185 million disability-adjusted life years. For this reason, it is one of the most important public health problems in all countries in the world that entails high health and social spending.
The non-pharmacological strategy with the most evidence currently to improve the quality of life of patients and also prevent subsequent cardiovascular events are cardiac rehabilitation programs (CRP). These include smoking cessation, control of other cardiovascular risk factors, health education, psychological therapy and a multimodal exercise program. Two types of exercise are performed, cardiovascular or aerobic resistance and strength. There is limited evidence on the addition of inspiratory muscle training (IMT) in people with MI. For this reason, it is not routinely recommended in clinical practice guidelines. Therefore, this thesis project, based on a clinical trial, tries to increase knowledge on this topic.
In view of the above, the main objective of this project is to analyze the effectiveness of adding inspiratory muscle training to a CRP of people with ischemic heart disease revascularized by percutaneous transluminal coronary angioplasty (PTCA) after 16 intervention sessions, based on to functional capacity, in addition to muscle strength, social support, anxiety, depression, coping with the disease, sexual dysfunction, quality of life, quality of sleep, eating habits and body composition. On the other hand, the secondary objectives are to know the biopsychosocial profile of this population and analyze gender differences through a subgroup analysis.
To achieve these objectives, a low-risk randomized and controlled clinical trial will be carried out in parallel at the Virgen de la Victoria University Hospital in Málaga (HUVV). People from this health area diagnosed with MI who have undergone PTCA will be recruited. The control group will complete the usual 8-week cardiac rehabilitation program with 2 weekly sessions of multicomponent exercise (cardiovascular and strength), one weekly session of health education and another of group psychological therapy. The intervention group will do the same program to which an IMT will be added. It will be performed with loads of 70% of the Maximum Inspiratory Pressure (MIP) value, completing 3 sets of 10 repetitions, 4 days a week, with 3 minutes of rest between sets, during the 8 weeks that the PRC lasts. Different measurements will be made and various tests and questionnaires will be passed before and after the PRC and the effect of adding or not adding the IMT on the variables to be analyzed will be analyzed using statistical methods.
It is expected that some of the variables will improve since there is some evidence (low and moderate) of this, as concluded by a recent review. Furthermore, in similar clinical populations such as patients with heart failure (HF), there is a high level of evidence that several of these parameters improve. Therefore, it can be expected that the results are similar in MI. In those variables without prior evidence, we hypothesize that there will be an improvement, since increasing MIP in isolation has been shown, in different clinical populations, to improve the functional capacity and quality of life of the study subjects.
If the expected benefits are finally observed, the current evidence on the use of IMT in CRPs for people with MI and PTCA will increase. In anticipation of the accumulated evidence of the effectiveness of the proposed treatment, the results derived from the present study may recommend including the IMT as another fundamental component of the CRP for this subgroup of patients.
Inclusion: people with Myocardial Ischemia and percutaneous transluminal coronary angioplasty; both sexes; over 18 years old; under 80 years of age; absence of cognitive deficits and/or physical limitations that would prevent them from performing physical exercise or completing the questionnaires required for participation in the study.
Exclusion: disease or condition that contraindicates exercise such as severe hypertrophic obstructive cardiomyopathy; severe aortic stenosis and/or dissecting aortic aneurysm; patients who refuse treatment or do not sign the informed consent.