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

Summary

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.

Conditions

• Myocardial Ischemia
• Coronary Arterial Disease (CAD)

Interventions

DEVICE

Inspiratory muscle training

The control group will perform a standard cardiac rehabilitation program, consisting of 16 multicomponent exercise sessions, health education, and a weekly group of psychological therapy session. The intervention group will do the same program with the addition of Inspiratory Muscle Training (IMT). The following device will be used: Power Breath model: Medic Classic. The training will be performed by adjusting the device load to 70% of the Maximum Inspiratory Pressure value, performing 1 daily training session 4 days a week of 3 sets of 10 repetitions, with a rest of 3 minutes between sets, during 8 weeks. A physical therapist will teach participants how to use the device on the first day and they will be instructed to perform it at home. They will be given a diary to record their compliance. In addition, once a week the physiotherapist will supervise the execution of the IMT by the participants.

DEVICE

Sham Inspiratory muscle training

The control group will be given the same device as experimental group, but the load for all of the participants of the control group will be 5cm de H2O. This load is so low that it´s not able to induce improvement of the inspiratory musculature.

Sponsors & Collaborators

• University of Cadiz

  lead OTHER

Principal Investigators

• Jose Antonio Moral Muñoz, MSc, Phd · University of Cadiz

• Jose Maria Zuazagoitia de la Lama-Noriega, MSc, PhD student · University of Cadiz

• Adela Maria Gomez Gonzalez, PhD, Medical Doctor · Hospital Universitario Virgen de la Victoria

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-11

Primary Completion

2026-03-31

Completion

2026-03-31

Countries

• Spain

Study Locations