NCT03966417

Brief Summary

In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

June 18, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

May 25, 2019

Last Update Submit

October 31, 2022

Conditions

Aortic Valve StenosisTAVITranscatheter Aortic Valve ImplantationRehabilitation

Keywords

exercise training

Outcome Measures

Primary Outcomes (1)

  • Change of maximal oxygen uptake during exercise

    ml/kg/min

    3 months

Secondary Outcomes (8)

  • Change of flow-mediated dilatation (FMD) of the brachial artery

    3 months

  • Change of arterial stiffness coefficient

    3 months

  • Change of value of blood N terminal-proBNP

    3 months

  • Change of value of blood D-dimer

    3 months

  • Change of value from-the-questionnaire-obtained quality of life

    3 months

  • +3 more secondary outcomes

Other Outcomes (1)

  • Change of heart rate recovery

    3 months

Study Arms (2)

Exercise training group

ACTIVE COMPARATOR

Patient to be randomized to "exercise training group" will have exercise training sessions 2 times per week for a period of 12 weeks. They will undergo moderate continuous exercise training at 75% of Vo2max.

Other: Exercise training

Usual care group

NO INTERVENTION

Patient to be randomized to "usual care group" will undergo standard care fo 12 weeks.

Interventions

Exercise trainingOTHER

Continuous exercise training 2 times per week for a period of 12 weeks.

Also known as: Rehabilitation
Exercise training group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • movability (100 meters or more on 6-minute walking test after TAVI),
  • ability to attend a 12 week exercise training program,
  • physical and clinical ability to attend the rehabilitation program at the discretion of the researcher,
  • optimal medical treatment,

You may not qualify if:

  • contraindications for exercise training,
  • unstable hearth (uncontrollable heart failure - New York Heart Association stage IV, dysrhythmias, uncontrollable myocardial ischemia),
  • patient's decision to undergo TAVI despite receiving a recommendation for Surgical Aortic Valve Repair by the heart team,
  • non-cardiac physical impairment that would prevent exercise training on stationary bike,
  • uncontrolled pulmonary disease (FEV1 \<50%),
  • echocardiographic signs of prosthesis dysfunction according to the Valve Academic Research Consortium (valve orifice area of b1.2 cm2 plus a mean transaortic pressure gradient of ≥20 mm Hg, or a velocity of ≥3 m/s, at least moderate paravalvular regurgitation),
  • TAVI access site complication,
  • important peripheral vascular disease, musculoskeletal disease or central nervous system disease, which prevents exercise training on stationary bike,
  • recent (less than 3 months) acute events or illnesses that are contraindications for exercise training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (8)

  • Chakos A, Wilson-Smith A, Arora S, Nguyen TC, Dhoble A, Tarantini G, Thielmann M, Vavalle JP, Wendt D, Yan TD, Tian DH. Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond. Ann Cardiothorac Surg. 2017 Sep;6(5):432-443. doi: 10.21037/acs.2017.09.10.

    PMID: 29062738BACKGROUND

  • Pressler A, Christle JW, Lechner B, Grabs V, Haller B, Hettich I, Jochheim D, Mehilli J, Lange R, Bleiziffer S, Halle M. Exercise training improves exercise capacity and quality of life after transcatheter aortic valve implantation: A randomized pilot trial. Am Heart J. 2016 Dec;182:44-53. doi: 10.1016/j.ahj.2016.08.007. Epub 2016 Aug 26.

    PMID: 27914499BACKGROUND

  • Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.

    PMID: 26419744BACKGROUND

  • McMahon SR, Ades PA, Thompson PD. The role of cardiac rehabilitation in patients with heart disease. Trends Cardiovasc Med. 2017 Aug;27(6):420-425. doi: 10.1016/j.tcm.2017.02.005. Epub 2017 Feb 15.

    PMID: 28318815BACKGROUND

  • Butchart EG, Gohlke-Barwolf C, Antunes MJ, Tornos P, De Caterina R, Cormier B, Prendergast B, Iung B, Bjornstad H, Leport C, Hall RJ, Vahanian A; Working Groups on Valvular Heart Disease, Thrombosis, and Cardiac Rehabilitation and Exercise Physiology, European Society of Cardiology. Recommendations for the management of patients after heart valve surgery. Eur Heart J. 2005 Nov;26(22):2463-71. doi: 10.1093/eurheartj/ehi426. Epub 2005 Aug 15.

    PMID: 16103039BACKGROUND

  • 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: 24577878BACKGROUND

  • 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: 23757283BACKGROUND

  • Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.

    PMID: 33962483DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

ExerciseRehabilitation

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Borut Jug, MD, PhD

    University Medical Centre Ljubljana, Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. Borut Jug, MD, PhD

Study Record Dates

First Submitted

May 25, 2019

First Posted

May 29, 2019

Study Start

June 18, 2019

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)