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The Impact of Cardiac Prehabilitation on Clinical Outcomes: A comparison between Surgical Aortic Valve Replacement (sAVR) and Transcatheter Aortic Valve Implantation (TAVI).

The Impact of Cardiac Prehabilitation on Clinical Mental Health Outcomes: A comparison between Surgical Aortic Valve Replacement (sAVR) and Transcatheter Aortic Valve Implantation (TAVI).

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001069741
Enrollment
60
Registered
2022-08-02
Start date
2023-01-03
Completion date
2024-12-12
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The major aim of this project is to test the effectiveness of Cardiac Prehabilitation aimed at reducing anxiety, depression and distress in patients with aortic stenosis undergoing either sAVR or TAVI as cardiac interventions. This will be assessed by comparing each group against their control arm of cardiac patients in the surgery waitlist. In addition, we will examine whether prehabilitation has been more effective in either sAVR or TAVI. It is expected that those undergoing sAVR will demonstrate higher rates of baseline psychological distress than those undergoing TAVI. A secondary aim is to gauge whether undertaking a web-based intervention has resulted in higher rates of cardiac rehabilitation uptake than is usually seen in this population. This research will contribute to the current lack of research in the area of early interventions in cardiac patients with aortic stenosis.

Interventions

This study aims to investigate the effectiveness of preoperative psychological interventions for in patients awaiting sAVR and TAVI surgery. Patients will undergo a four online (telehealth) sessions of psychocardiac prehabilitation delivered by a clinical/health psychologist, where they will be provided with psychoeducation regarding their procedure and likely emotional responses, basics of cognitive behaviour therapy and mindfulness as well as relaxation exercises. Each session will be for 1

This study aims to investigate the effectiveness of preoperative psychological interventions for in patients awaiting sAVR and TAVI surgery. Patients will undergo a four online (telehealth) sessions of psychocardiac prehabilitation delivered by a clinical/health psychologist, where they will be provided with psychoeducation regarding their procedure and likely emotional responses, basics of cognitive behaviour therapy and mindfulness as well as relaxation exercises. Each session will be for 1 hour and it will take place once a week for four weeks. the treatment approach will follow a procedure consisting of 4 basic stages: cognitive preparation, skill acquisition, rehearsal, and application practice. Session 1 will cover psychoeducation about their condition and the proposed links between mental stress and heart disease, session two will cover mindfulness training with a focus on compassion aimed at improving self control, session three will involve the therapist and client working through the use of the mindfulness intervention and session four will cover application of the intervention technique in different settings and situations. Participants will be provided with specific study designed information handouts for each session. Participants undergoing both sAVR and TAVI will log into their sessions with the psychologist, just as logging into a telehealth session with their health provider. The sessions will be over a safe cloud communication and collaboration product such as Ring Central or MS Teams. The Prehabilitation sessions will take place in the 4 weeks prior to surgery with the last session scheduled on the week of surgery. Both groups will receive the same intervention. Participants will be monitored for attendance during intervention and followed up after surgery and at six months post surgery

Sponsors

Federation University Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients awaiting sAVR or TAVI

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026