Coronary Artery Bypass GraftNCT06127147
High-intensity Inspiratory Muscle Training as a Pre-cardiac Rehabilitation in Heart Disease
A study testing IMT in people with Coronary Artery Bypass Graft and CABG, run by University of Illinois at Chicago at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft, CABG
- What is being tested?
- IMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2023to 15 Jun 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois at Chicago
Chicago, Illinois, 60608
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
Official title: Effects of High-intensity Inspiratory Muscle Training as a Pre-cardiac Rehabilitation Intervention on Cardiovascular Functions in Patients With Heart Disease
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.
Read the detailed description
Background: Cardiovascular diseases (CVD) remain a leading cause of morbidity and mortality in both men and women in developed and developing societies (Joseph et al., 2017). Some degree of pulmonary dysfunction is highly likely in patients with heart disease compared to those without(Calles et al., 2016; Cahalin and Arena, 2015). This can affect pulmonary function, and gas exchange, as well as decrease maximum inspiratory and expiratory pressures (MIP and MEP, respectively)(Dos Santos et al., 2019; Haeffener et al., 2008; Roncada et al., 2015; Cahalin and Arena, 2015).
Inspiratory muscle training has been shown to be an effective form of training that enhances lung function. It consists of repetitive breath cycles where one inspires against resistance placed by a device and expires against no resistance. Studies that have applied this form of training in patients with heart disease have found significant improvements in MIP-MEP, tidal volume, vital capacity, and 6-minute walking distance. Few studies have examined the effects of high-intensity (between 50-80% of MIP) inspiratory muscle training in patients with heart disease (Dos Santos et al., 2019; Dos Santos et al., 2021; Laoutaris et al., 2007; Miozzo et al., 2018; Sadek et al., 2022). This level of training has been associated with greater improvements in the aferomentioned outcomes of interest, however, no study has explored the effects of high-intensity inspiratory muscle training in patients with heart disease on measures of cardiovascular function.
Aim: This study aims to investigate and interpret whether high-intensity inspiratory muscle training, beyond the usual care, improves endothelial function and arterial stiffness on cardiovascular function in patients with heart disease.
Methods: The study was designed as a randomized controlled trial. After coronary artery bypass graft surgery, patients will be invited to the study. The demographic and clinical characteristics of the patients will be recorded after consent is obtained from the volunteer patients who meet the inclusion criteria. Subsequently, patients will be randomly divided into two groups for inspiratory muscle training (IMT) with 60% maximum inspiratory pressure (MIP) or sham inspiratory muscle training (Sham-control), for 4 weeks. In both groups, before and after 4-week training, resting blood pressure (systolic/diastolic), resting heart rate, endothelial function, arterial stiffness, functional exercise capacity, the severity of dyspnea, and inspiratory muscle functions will be measured.
- Conditions
- Coronary Artery Bypass Graft, CABG
- Being tested
- IMT, Sham-IMT
- Keywords
- coronary artery bypass graft, inspiratory muscle training, endothelial function, arterial stiffness, CABG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMTDevice
The IMT protocol will consist of high-intensity daily training - 2 sets of 30 breaths with a 1-minute rest between sets, twice a day for 4 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 60% of each patient's maximal inspiratory pressure.
Sham-IMTDevice
The sham IMT protocol will consist of high-intensity daily training - 2 sets of 30 breaths with a 1-minute rest between sets, twice a day for 4 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc) without intensity.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Patients who will perform inspiratory muscle training (IMT) with %60 of MIP intensity Receives: Device: IMT |
| Sham Group | Sham comparator | Patients who will perform Sham-IMT Receives: Device: Sham-IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Muscle Function
maximal inspiratory pressure (MIP) is the highest pressure measured during inspiration will be used.
Measured: 4 weeks
Endothelial Function
flow-mediated dilation (FMD) ultrasound measurements of brachial artery flow-mediated dilatation will be performed.
Measured: 4 weeks
Arterial Stiffness
arterial stiffness will be assessed by measuring pulse wave velocity.
Measured: 4 weeks
Secondary outcomes (2)
Functional Exercise Capacity
maximal distance in 6 minute walk test will be used.
Measured: 4 weeks
Dyspnea
The modified Medical Research Council (mMRC) Dyspnea Scale, which have 5 points (0 to 4) will be used. High scores presented worsen dyspnea.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start20 Dec 2023
- Primary completion7 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
- Investigators
- Cemal Ozemek, Assoc. Prof., Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127147
- Sponsor's protocol ID
- STUDY2023-1089
- Status last verified
- Nov 2025
- First submitted
- 6 Nov 2023
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dos Santos TD, Pereira SN, Portela LOC, Cardoso DM, Lago PD, Dos Santos Guarda N, Moresco RN, Pereira MB, de Albuquerque IM. Moderate-to-high intensity inspiratory muscle training improves the effects of combined training on exercise capacity in patients after coronary artery bypass graft surgery: A randomized clinical trial. Int J Cardiol. 2019 Mar 15;279:40-46. doi: 10.1016/j.ijcard.2018.12.013. Epub 2018 Dec 10.
PubMed 30581100Miozzo AP, Stein C, Marcolino MZ, Sisto IR, Hauck M, Coronel CC, Plentz RDM. Effects of High-Intensity Inspiratory Muscle Training Associated with Aerobic Exercise in Patients Undergoing CABG: Randomized Clinical Trial. Braz J Cardiovasc Surg. 2018 Jul-Aug;33(4):376-383. doi: 10.21470/1678-9741-2018-0053.
PubMed 30184035Fernandez-Rubio H, Becerro-de-Bengoa-Vallejo R, Rodriguez-Sanz D, Calvo-Lobo C, Vicente-Campos D, Chicharro JL. Inspiratory Muscle Training in Patients with Heart Failure. J Clin Med. 2020 Jun 2;9(6):1710. doi: 10.3390/jcm9061710.
PubMed 32498445Sadek Z, Salami A, Joumaa WH, Awada C, Ahmaidi S, Ramadan W. Best mode of inspiratory muscle training in heart failure patients: a systematic review and meta-analysis. Eur J Prev Cardiol. 2018 Nov;25(16):1691-1701. doi: 10.1177/2047487318792315. Epub 2018 Aug 3.
PubMed 30073849Roncada G, Dendale P, Linsen L, Hendrikx M, Hansen D. Reduction in pulmonary function after CABG surgery is related to postoperative inflammation and hypercortisolemia. Int J Clin Exp Med. 2015 Jul 15;8(7):10938-46. eCollection 2015.
PubMed 26379888Haeffener MP, Ferreira GM, Barreto SS, Arena R, Dall'Ago P. Incentive spirometry with expiratory positive airway pressure reduces pulmonary complications, improves pulmonary function and 6-minute walk distance in patients undergoing coronary artery bypass graft surgery. Am Heart J. 2008 Nov;156(5):900.e1-900.e8. doi: 10.1016/j.ahj.2008.08.006. Epub 2008 Oct 5.
PubMed 19061704Cahalin LP, Arena RA. Breathing exercises and inspiratory muscle training in heart failure. Heart Fail Clin. 2015 Jan;11(1):149-72. doi: 10.1016/j.hfc.2014.09.002.
PubMed 25432483Kenji Nawa R, Daros Dos Santos T, Albiero Real A, Correa Matheus S, Tatsch Ximenes M, Machado Cardoso D, Martins de Albuquerque I. Relationship between Perme ICU Mobility Score and length of stay in patients after cardiac surgery. Colomb Med (Cali). 2022 Jul 30;53(3):e2005179. doi: 10.25100/cm.v53i3.5179. eCollection 2022 Jul-Sep.
PubMed 37152522Joseph P, Leong D, McKee M, Anand SS, Schwalm JD, Teo K, Mente A, Yusuf S. Reducing the Global Burden of Cardiovascular Disease, Part 1: The Epidemiology and Risk Factors. Circ Res. 2017 Sep 1;121(6):677-694. doi: 10.1161/CIRCRESAHA.117.308903.
PubMed 28860318Mummery RS, Rothschild M, Valadon LR. Carotenoids in two silk moths Saturnia pavonia L. and Actia luna L. Comp Biochem Physiol B. 1975 Jan 15;50(1):23-8. doi: 10.1016/0305-0491(75)90293-x. No abstract available.
PubMed 1122717