Exercise Training After Transcatheter Aortic Valve Implantation

NCT ID: NCT01935297

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-01-31

Brief Summary

This pilot study will evaluate the effect of a rehabilitative exercise training on exercise capacity in patients after percutaneous aortic valve replacement. It will additionally evaluate the safety of such an approach and the effect on life quality. We hypothesize that regular structured exercise improves exercise capacity in these patients beyond the sole effect of the valve procedure.

Detailed Description

The study will include 30 patients and randomize them in a 1:1-fashion to either a training or a usual care group. The training group will undergo 8 weeks of combined endurance and resistance training according to a standard protocol, but with individual adjustment if required. The usual care group will receive general advice but no structured exercise program. Exercise capacity is assessed by cardiopulmonary exercise testing and by the 6 minute walk test prior to and after the intervention period. In addition, life quality will be assessed by validated questionnaires, while safety will be assessed by recording adverse events and by echocardiography.

Conditions

Transcatheter Aortic Valve Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise

8 weeks of supervised, structured, combined endurance and resistance training

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

endurance and resistance exercise 3x/week for 8 weeks

Control

Patients receive usual care, regular exercise is not recommended but also not prohibited

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

endurance and resistance exercise 3x/week for 8 weeks

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

patients up to 6 months after transcatheter aortic valve implantation

Exclusion Criteria

inability to perform exercise on bicycles valve dysfunction

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: collaborator

Klinikum der Universitaet Muenchen, Grosshadern

OTHER

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Axel Pressler, MD

Role: PRINCIPAL_INVESTIGATOR

Prevention, Rehabilitation & Sports Medicine, Technische Universität München, Germany

Locations

Department of prevention, rehabilitation and sports medicine

Munich, Bavaria, Germany

Countries

Germany

References

Pressler A, Forschner L, Hummel J, Haller B, Christle JW, Halle M. Long-term effect of exercise training in patients after transcatheter aortic valve implantation: Follow-up of the SPORT:TAVI randomised pilot study. Eur J Prev Cardiol. 2018 May;25(8):794-801. doi: 10.1177/2047487318765233. Epub 2018 Mar 19.

Reference Type: DERIVED

PMID: 29553289 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27914499 (View on PubMed)

Other Identifiers

F/14/12

Identifier Type: -

Identifier Source: org_study_id