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

NCT02468219 | Unknown

• 1 other identifier: IR00002509/FWA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Valve Stenosis

Keywords

aortic stenosis; aortic valve replacement; transcatheter aortic valve implantation; frailty; cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory function

  Peak oxygen consumption (VO2PEAK), among other physiologic markers.

  Changes from 8 and 16 weeks

Secondary Outcomes (10)

• Autonomic function

  Change from 2, 8 and 16 weeks

• Endothelial function

  Changes from 2, 8 and 16 weeks

• Hemodynamic function

  Changes from 2, 8 and 16 weeks

• Inflammatory profile

  Changes from 2, 8 and 16 weeks

• Inspiratory muscle strength

  Changes from 2, 8 and 16 weeks

Study Arms (2)

aortic valve replacement

ACTIVE COMPARATOR

patients with aortic stenosis submitted to aortic valve replacement procedure

Behavioral: cardiovascular rehabilitation program

transcatheter aortic valve implantation

EXPERIMENTAL

patients with aortic stenosis who underwent to transcatheter aortic valve implantation

Behavioral: cardiovascular rehabilitation program

Interventions

cardiovascular rehabilitation program BEHAVIORAL

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.

aortic valve replacement; transcatheter aortic valve implantation

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Irmandade Santa Casa de Misericórdia de Porto Alegre: lead
• Federal University of Health Science of Porto Alegre: collaborator

Study Sites (1)

Marlus Karsten

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Related Publications (5)

• 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.

  PMID: 24631801 BACKGROUND

• 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.

  PMID: 23757283 BACKGROUND

• Voller 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.

  PMID: 24577878 BACKGROUND

• Fauchere I, Weber D, Maier W, Altwegg L, Luscher TF, Grunenfelder J, Nowak A, Tuller 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. No abstract available.

  PMID: 24713461 BACKGROUND

• 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. doi: 10.1097/HJR.0b013e328339b5a2.

  PMID: 20560163 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Frailty

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marlus Karsten, PhD

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlus Karsten, PhD

CONTACT

55 51 33038876; mkarsten@ufcspa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study will be divided into four phases: phase 1 (pre-procedure rehabilitation); phase 2 (early post-procedure rehabilitation); phase 3 (late post-procedure rehabilitation), and phase 4 (follow-up).

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: June 10, 2015
• Study Start: August 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

BR (1)