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N/A Completed N=11 Randomized Double-blind Treatment

High-intensity Inspiratory Muscle Training as a Pre-cardiac Rehabilitation in Heart Disease

Source: ClinicalTrials.gov NCT06127147 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Inspiratory Muscle Function — 46.4; 52.8; 68.8; 50.0 cm H2O

Summary

Background/aim: Endothelial function is closely associated with coronary artery health among individuals being treated for heart disease. An impairment in endothelial function promotes arterial stiffening that directly contributes to elevated systolic blood pressure as a result of increased vascular resistance. Inspiratory muscle training is simply a form of training consisting of repeated inspirations against resistance. Inspiratory muscle training has also been applied to patients with chronic disease or as an additional therapy for cardiac rehabilitation and it has proven to be safe in these groups. Few studies in the literature examined the effects of high-intensity inspiratory muscle training in this population, however, these studies did not examine the direct effects of inspiratory muscle training on vascular function. To the best of our knowledge, the effects of inspiratory muscle training in patients with heart disease on endothelial function and arterial stiffness prior to starting cardiac rehabilitation have not been investigated. This study aims to investigate and interpret whether high-intensity inspiratory muscle training, beyond the usual care of heart disease, improves endothelial function and arterial stiffness. Methods: The study was designed as a randomized controlled trial. Patients will be allocated for inspiratory muscle training (IMT) with 60% of maximum inspiratory pressure (MIP) or sham inspiratory muscle training (Sham-control), for 4 weeks. In both groups, before and after 4-week training, cardiovascular functions will be measured and compared.

Outcome Measures

OutcomeResultp-value
PRIMARY
Inspiratory Muscle Function
46.4; 52.8; 68.8; 50.0
PRIMARY
Endothelial Function
5.41; 3.88; 7.53; 3.00 .001 sig
PRIMARY
Arterial Stiffness
6.19; 5.57; 6.11; 5.58 .001 sig
SECONDARY
Functional Exercise Capacity
301; 309.2; 340.4; 305.0 <0.001 sig
SECONDARY
Dyspnea
2.8; 2.5; 1.6; 2.7 <0.001 sig

Eligibility Criteria

Inclusion Criteria

  • Aged >18 years old
  • Be able to walk independently.
  • Had coronary artery bypass graft (CABG) surgery, history of percutaneous coronary interventions, heart failure, and/or myocardial infarction.
  • Sufficient English language comprehension and cognitive ability to understand the study protocol, give informed consent and follow instructions.

Exclusion Criteria

  • Being a current smoker (or tobacco).
  • Having a diagnosed chronic disease such as inflammatory bowel disease/irritable bowel syndrome, cerebrovascular diseases, COPD, chronic kidney disease requiring dialysis, neurological disorders, or diseases that may affect motor/cognitive function [multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia, or other brain diseases of ageing])
  • Getting a score below 24 on the Standardized Mini Mental Test
  • Using antipsychotic medications commonly used to treat schizophrenia or schizoaffective disorders (i.e., haloperidol)
  • Having had any other previous cardiothoracic operation except CABG (e.g. Pneumonectomy, lobectomy, etc.)
  • Having a history of unstable-angina
  • Having had pneumonia in the last 3 months
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06127147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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