Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction

Aortic Valve Stenosis Clinical Trial

— CARE-AS-MOTION  

Official title:

Cardiovascular RehAbilitation in Patients With Severe AoRtic StEnosis Submitted to Valvar Correction: Effects on Muscle Architecture, Tissue Oxygenation, EndoThelial Function, Inflammatory Profile, and AutoNomic Control - Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02468219
• Other study ID #: IR00002509/FWA
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: July 2022

Study information

• Verified date: May 2020
• Source: Irmandade Santa Casa de Misericórdia de Porto Alegre
• Contact: Marlus Karsten, PhD
• Phone: 55 51 33038876
• Email: mkarsten[@]ufcspa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be evaluate the autonomic, endothelial and hemodynamic functions, inspiratory muscle strength, peripheral tissue oxygenation, peripheral and respiratory muscle architecture, and inflammatory profile of severe AS patients submitted undergoing to valve replacement (sAVR) or transcatheter aortic valve implantation (TAVI), and their influence on the pathophysiological mechanisms involved in cardiovascular rehabilitation.

Description:

Background: Aortic stenosis (AS) is a disease characterized by the inadequate valve opening, compromising the cardiac output. Surgical aortic valve replacement (sAVR) is the procedure indicates for valve repair in AS symptomatic cases whereas the transcatheter aortic valve implantation (TAVI) is the procedure indicates for sAVR contraindicated cases.

Objective: To evaluate the effect of the cardiac rehabilitation program (pre-procedure, early post-procedure, and late post-procedure) in autonomic, endothelial and hemodynamic functions, inspiratory muscle strength, peripheral tissue oxygenation, peripheral and respiratory muscle architecture, and inflammatory profile of severe AS patients submitted to a valve repair procedure (sAVR or TAVI).

Methods: The present study will be a randomized double-blind clinical trial in patients indicated to valve repair procedure. This research will be divided into four phases: phase 1 (pre-procedure); phase 2 (early post-procedure); phase 3 (late post-procedure) and phase 4 (follow-up). Phase 1: participants will be randomized in PR-I (pre-intervention) or PR-C (control). Pre-procedure rehabilitation program will consist of daily neuromuscular electrical stimulation (NMES) in knee extensor muscles and inspiratory muscle training (IMT) sessions. PR-C group will receive daily visits, but with a NMES + IMT protocols using a minimal load. Phase 2: a new random will be done between ER-II or ER-CI (intervention) and ER-IC or ER-CC (control). Intervention groups will undertake an early post-procedure rehabilitation (NMES in knee extensor muscle plus IMT for six weeks). Control groups will receive the same protocol using a minimal load without load progression. Phase 3: all patients will be referred to the conventional cardiac rehabilitation program (aerobic and resistance training) for 8-weeks. Phase 4: follow-up (no interventions), will be done after 3, 6, 9 and 12 months. Assessment protocol will be composed by cardiopulmonary exercise test, autonomic (heart rate variability), endothelial (flow-mediated vasodilation), hemodynamic function (cardiothoracic impedance) functional capacity (six-minute walk test), maximum inspiratory pressure, peripheral and respiratory muscle architecture (ultrasonography), and tissue oxygenation (near-infrared spectroscopy), and inflammatory profile (OxLDL, TGF-β, TNF-α, IL-1b, IL-10 and ICAM-1) Appropriate statistic tests will be used to compare the time-rehabilitation (experimental vs sham) and group-interaction (sAVR vs TAVI). If samples are abandoned or lost, basal data will be double entered to characterize the intention-to-treat analysis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: July 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria: patients NYHA class II-IV who has not participated in a CRP three months before recruitment; older than 40 years; of both genders; with degenerative AS and indication for valve repair. The patients will not know which protocol to undergo.

Exclusion Criteria: patients with low cognitive level to perform the assessment or intervention procedures; that exhibit unstable angina or any contraindications for the treatment or measurements; as well musculoskeletal, cerebrovascular, or psychiatric disease that prevents their participation in the research.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Behavioral:
• cardiovascular rehabilitation program
Phase I: 2-weeks of respiratory muscle training and neuromuscular electrical stimulation (daily at hospital). Phase II: 6-weeks of respiratory muscle training and neuromuscular electrical stimulation (daily at home). Phase III: 8-weeks of supervised, structured, combined aerobic and resistance training.

Locations

Country	Name	City	State
Brazil	Marlus Karsten	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Irmandade Santa Casa de Misericórdia de Porto Alegre	Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Fauchère I, Weber D, Maier W, Altwegg L, Lüscher TF, Grünenfelder J, Nowak A, Tüller D, Genoni M, Falk V, Hermann M. Rehabilitation after TAVI compared to surgical aortic valve replacement. Int J Cardiol. 2014 May 15;173(3):564-6. doi: 10.1016/j.ijcard.2014.03.121. Epub 2014 Mar 21. — View Citation

Montemezzo D, Fregonezi GA, Pereira DA, Britto RR, Reid WD. Influence of inspiratory muscle weakness on inspiratory muscle training responses in chronic heart failure patients: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Jul;95(7):1398-407. doi: 10.1016/j.apmr.2014.02.022. Epub 2014 Mar 13. Review. — View Citation

Russo N, Compostella L, Tarantini G, Setzu T, Napodano M, Bottio T, D'Onofrio A, Isabella G, Gerosa G, Iliceto S, Bellotto F. Cardiac rehabilitation after transcatheter versus surgical prosthetic valve implantation for aortic stenosis in the elderly. Eur J Prev Cardiol. 2014 Nov;21(11):1341-8. doi: 10.1177/2047487313494029. Epub 2013 Jun 11. — View Citation

Sbruzzi G, Ribeiro RA, Schaan BD, Signori LU, Silva AM, Irigoyen MC, Plentz RD. Functional electrical stimulation in the treatment of patients with chronic heart failure: a meta-analysis of randomized controlled trials. Eur J Cardiovasc Prev Rehabil. 2010 Jun;17(3):254-60. Review. — View Citation

Völler H, Salzwedel A, Nitardy A, Buhlert H, Treszl A, Wegscheider K. Effect of cardiac rehabilitation on functional and emotional status in patients after transcatheter aortic-valve implantation. Eur J Prev Cardiol. 2015 May;22(5):568-74. doi: 10.1177/2047487314526072. Epub 2014 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory function	Peak oxygen consumption (VO2PEAK), among other physiologic markers.	Changes from 8 and 16 weeks
Secondary	Autonomic function	will be evaluated by heart rate variability using a wrist heart rate monitor following the recommendations of ESC/NASPE Task Force.	Change from 2, 8 and 16 weeks
Secondary	Endothelial function	will be investigated by endothelium-dependent flow-mediated vasodilation (FMD) technique following the International Brachial Artery Reactivity Task Force.	Changes from 2, 8 and 16 weeks
Secondary	Hemodynamic function	will be evaluated the cardiac output using a cardiothoracic impedance device (noninvasive approach).	Changes from 2, 8 and 16 weeks
Secondary	Inflammatory profile	Plasma levels will be determined by enzyme-linked immunosorbent assay using commercial systems.	Changes from 2, 8 and 16 weeks
Secondary	Inspiratory muscle strength	Will be assessed as maximum inspiratory pressure (MIP) using a digital device following recommendations of the American Thoracic Society and European Respiratory Society.	Changes from 2, 8 and 16 weeks
Secondary	Muscle architecture (peripheral muscles)	Will be evaluated the muscle thickness (cross-sectional area) of quadriceps using a ultrasonography system.	Changes from 8 and 16 weeks
Secondary	Muscle architecture (respiratory muscles)	Will be evaluated the diaphragm thickness (cross-sectional area) of quadriceps using a ultrasonography system.	Changes from 8 and 16 weeks
Secondary	Tissue oxygenation	near-infrared spectroscopy (NIRS) will be used to verify muscle oxygenation (quadriceps and respiratory muscles).	Changes from 2, 8 and 16 weeks
Secondary	Functional capacity	The patients under favorable clinical conditions will be functionally evaluated by the Six-Minute Walk Test (6MWT) according to current guidelines.	Changes from 8 and 16 weeks
Secondary	Mortality	to evaluate the survival rate of the patients	Change from 3, 6 and 12 months post protocol