Effectiveness of Adding Inspiratory Muscle Training to Cardiac Rehabilitation for Adults With Ischemic Heart Disease Treated by Percutaneous Transluminal Coronary Angioplasty
Led by University of Cadiz · Updated on 2025-09-29
72
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Myocardial Ischemia MI is a condition caused by narrowing of the arteries supplying blood to the heart muscle, leading to reduced oxygen flow which can cause chest pain or heart attacks. It is a leading cause of death worldwide and represents a major public health issue. Cardiac rehabilitation programs CRP that include lifestyle changes, education, psychological support, and exercise are key non-drug treatments to improve quality of life and prevent further heart problems. This research aims to study the addition of inspiratory muscle training IMT to a CRP for people with MI who have undergone percutaneous transluminal coronary angioplasty PTCA.
The study is a low-risk randomized controlled trial comparing two groups over an 8-week cardiac rehabilitation period. Both groups participate in usual CRP sessions involving aerobic and strength exercises, health education, and group psychological therapy. The intervention group adds IMT using a device set to 70% of their maximum inspiratory pressure, performing sets of breathing exercises at home four days a week, supervised weekly by a physiotherapist. The control group uses a similar device with a minimal load that acts as a placebo.
Participants will attend three weekly sessions at the hospital for exercise and education. Assessments before and after the program will measure functional capacity, muscle strength, social support, anxiety, depression, coping, sexual dysfunction, quality of life, sleep quality, eating habits, body composition, and other health indicators using tests, questionnaires, and imaging. Adherence is tracked with diaries and supervision. The research team will analyze results statistically to evaluate the effect of adding IMT to the rehabilitation program and explore gender differences and biopsychosocial profiles.
CONDITIONS
Brief Title
Effectiveness of Inspiratory Muscle Training for People With Ischemic Heart Disease Revascularized by Percutaneous Transluminal Coronary Angioplasty.
Research Team
J
Jose Maria Zuazagoitia de la Lama-Noriega, MSc, PhD student
A
Adela Maria Gomez Gonzalez, PhD, Medical Doctor
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People diagnosed with myocardial ischemia who have undergone percutaneous transluminal coronary angioplasty
Both men and women
Aged 18 years or older
Younger than 80 years
No cognitive or physical problems that prevent exercise or completing study questionnaires
You will not qualify if you...
Having a disease or condition that prevents exercise such as severe hypertrophic obstructive cardiomyopathy
Severe aortic stenosis or dissecting aortic aneurysm
Refusal to undergo treatment or not signing the informed consent form
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants undergo a cardiac rehabilitation program with 16 multicomponent exercise sessions, health education, and weekly group psychological therapy. The intervention group additionally performs inspiratory muscle training at home 4 days a week for 8 weeks, supervised weekly in person by a physiotherapist.
3 visits per week at the cardiac rehabilitation unit and weekly supervision of inspiratory muscle training
Follow-up
Duration - Up to 2 weeks after treatment ends
Participants complete assessments of functional capacity, muscle strength, social support, anxiety, depression, coping with disease, sexual dysfunction, quality of life, sleep quality, eating habits, and body composition up to 2 weeks after finishing the treatment.
1 visit (in-person) for post-treatment assessments
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.
Jose M Zuazagoitia-Lama-Noriega, A M Gómez-González, Jose A Moral-Munoz