NCT06681740: CARDIOINSPIRE

Effectiveness of Inspiratory Muscle Training for People With Ischemic Heart Disease Revascularized by Percutaneous Transluminal Coronary Angioplasty.

Recruiting now NA Last updated 29 September 2025

What this trial tests

NA trial testing Inspiratory muscle training in Myocardial Ischemia in 72 participants. Currently enrolling.

Timeline

11 November 2024

Primary endpoint
31 March 2026

31 March 2026

Quick facts

Lead sponsor	University of Cadiz
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	72
Start date	11 November 2024
Primary completion	31 March 2026
Estimated completion	31 March 2026
Sites	1 location across Spain

Drugs / interventions tested

• Inspiratory muscle training
• Sham Inspiratory muscle training

Conditions studied

• Myocardial Ischemia — all drugs for Myocardial Ischemia →
• Coronary Arterial Disease (CAD) — all drugs for Coronary Arterial Disease (CAD) →

Sponsor

University of Cadiz

Who can join

Adults 18 to 80, any sex, with Myocardial Ischemia or Coronary Arterial Disease (CAD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effectiveness of adding inspiratory muscle training to a cardiac rehabilitation program in people with acute myocardial infarction revascularized by percutaneous coronary intervention (CARDIOINSPIRE): Study protocol for a randomized controlled trial.
   Zuazagoitia-Lama-Noriega JM, Gómez-González AM, Moral-Munoz JA. · · 2026 · PMID 41805821 · DOI 10.1371/journal.pone.0343947