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

NCT06681740 | Recruiting

• 1 other identifier: SICEIA-2024-001869
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Myocardial Ischemia; Coronary Arterial Disease (CAD); Inspiratory Muscle Training; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Functional Capacity

  To assess functional capacity, a simple exercise stress test will be performed following the recommendations of the Spanish Society of Cardiology in which the maximum oxygen consumption (VO2max). Ergometry, also known as stress test, is not only a diagnostic technique that analyzes the response of the heart to exercise, but also a test that is able to quantify the oxygen consumption of the individual who performs it. In this study it will be performed on a treadmill. The Bruce protocol will be used, which progressively increases the speed of the treadmill and its inclination every 3 minutes. It will be performed by a cardiologist of the unit. VO2max will be obtained in METS (a metabolic equivalent 1 MET = 3.5 ml O2/kg/min).

  First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.

Secondary Outcomes (19)

• The Charlson Comorbidity Index

  Between recruitment and the start of intervention

• Sleep Quality

  First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.

• Level of physical activity

  First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.

• The left ventricular ejection fraction (LVEF)

  First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.

• Maximal Inspiratory Pressure (MIP)

  First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.MIP will be reassessed midway through the program to readjust the training load.

Study Arms (2)

Inspiratory muscle training group

EXPERIMENTAL

The intervention group will be given an inspiratory muscle training device that will be regulated at 70% of their Maximum Inspiratory Pressure. This load is able to induce improvements in their musculature.

Device: Inspiratory muscle training

Control group

SHAM COMPARATOR

The control group will be given an inspiratory muscle training device that will be regulated with a load of 5 cm H2O. This load is not sufficient to induce changes in the musculature, so it will function as a placebo.

Device: Sham Inspiratory muscle training

Interventions

Inspiratory muscle training DEVICE

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.

Also known as: IMT

Inspiratory muscle training group

Sham Inspiratory muscle training DEVICE

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.

Also known as: Sham

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead

Study Sites (1)

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

Related Publications (24)

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Related Links

• Information about Myocardial Ischemia in the Spanish Heart Foundation website
• Global epidemiology of Ischemia Heart Desease
• Guidelines of the Spanish Society of Cardiology for Clinical Practice in Exercise Testing

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jose Antonio Moral Muñoz, MSc, Phd

  University of Cadiz

  STUDY DIRECTOR

• Jose Maria Zuazagoitia de la Lama-Noriega, MSc, PhD student

  University of Cadiz

  PRINCIPAL INVESTIGATOR

• Adela Maria Gomez Gonzalez, PhD, Medical Doctor

  Hospital Universitario Virgen de la Victoria

  STUDY DIRECTOR

Central Study Contacts

Jose Maria Zuazagoitia de la Lama-Noriega, MSc, PhD student

CONTACT

+34 686776547; josemaria.zuazagoitia@uca.es

Adela Maria Gomez Gonzalez, PhD, Medical Doctor

CONTACT

+34 649713753; adelareha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University professor. Graduate in Physiotherapy. Master in New Trends in Health Sciences Research.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 8, 2024
• Study Start: November 11, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)