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

NCT06127147 | Completed Results FDA Device

• 1 other identifier: STUDY2023-1089
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

CABG; Coronary Artery Bypass Graft

Keywords

coronary artery bypass graft; inspiratory muscle training; endothelial function; arterial stiffness; CABG

Outcome Measures

Primary Outcomes (3)

• Inspiratory Muscle Function

  maximal inspiratory pressure (MIP) is the highest pressure measured during inspiration will be used.

  4 weeks

• Endothelial Function

  flow-mediated dilation (FMD) ultrasound measurements of brachial artery flow-mediated dilatation will be performed.

  4 weeks

• Arterial Stiffness

  arterial stiffness will be assessed by measuring pulse wave velocity.

  4 weeks

Secondary Outcomes (2)

• Functional Exercise Capacity

  4 weeks

• Dyspnea

  4 weeks

Study Arms (2)

Study Group

EXPERIMENTAL

Patients who will perform inspiratory muscle training (IMT) with %60 of MIP intensity

Device: IMT

Sham Group

SHAM COMPARATOR

Patients who will perform Sham-IMT

Device: Sham-IMT

Interventions

IMT DEVICE

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.

Study Group

Sham-IMT DEVICE

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.

Sham Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (10)

• 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.

  PMID: 30581100 BACKGROUND

• Miozzo 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.

  PMID: 30184035 BACKGROUND

• Fernandez-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.

  PMID: 32498445 BACKGROUND

• Sadek 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.

  PMID: 30073849 BACKGROUND

• Roncada 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.

  PMID: 26379888 BACKGROUND

• Haeffener 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.

  PMID: 19061704 BACKGROUND

• Cahalin 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.

  PMID: 25432483 BACKGROUND

• Kenji 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.

  PMID: 37152522 BACKGROUND

• Joseph 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.

  PMID: 28860318 BACKGROUND

• Mummery 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.

  PMID: 1122717 BACKGROUND

Results Point of Contact

• Title: Cemal Ozemek
• Organization: University of Illinois at Chicago

ozemek@uic.edu

312-355-3996

Study Officials

• Cemal Ozemek, Assoc. Prof.

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: December 20, 2023
• Primary Completion: June 7, 2024
• Study Completion: June 15, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)