None listed
Conditions
Brief summary
This study seeks to improve mid to long term outcomes and reduce frailty in post-TAVR patients by implementing a 3-month CR program in an outpatient setting which will include individualised exercise and education. The proposed study aims to provide a model of care that can be implemented in future community settings. Study hypothesis: 1) Patients who engage in outpatient exercise training program will have reduced frailty at six-months post-TAVR, and 2) patients who benefit most can be predicted.
Interventions
Non-drug trial.
Primary intervention: a three month cardiac rehabilitation program. This will be delivered in two phases - phase 1 (weeks 0-8) - supervised, 2 x weekly 60 minute individualised exercise sessions supervised and delivered by an Accredited Exercise Physiologist (AEP) on-site at a gym in a medical research facility. These sessions will be on non-consecutive days, with at least 1 day rest in between. Phase 2 (weeks 8-12) - telehealth, 1 x weekly sessions from the participant's home t
Non-drug trial. Primary intervention: a three month cardiac rehabilitation program. This will be delivered in two phases - phase 1 (weeks 0-8) - supervised, 2 x weekly 60 minute individualised exercise sessions supervised and delivered by an Accredited Exercise Physiologist (AEP) on-site at a gym in a medical research facility. These sessions will be on non-consecutive days, with at least 1 day rest in between. Phase 2 (weeks 8-12) - telehealth, 1 x weekly sessions from the participant's home to provide ongoing support and advice re: exercise and lifestyle. These sessions will run for 30-60 minutes depending on the needs of the participant. The AEP delivering the study will have minimum 5 years clinical experience working with cardiovascular patients and accredited with the governing body of Exercise & Sports Science Australia (ESSA). In addition they will have up to date first aid and CPR qualifications. The exercise intervention will be personalised for each person depending on their other medical conditions, exercise history and baseline testing (muscular endurance, submaximal fitness, etc). It will be based on best practice for patients post valve replacements using the guidelines listed in the CSANZ Position Statement on Prescription of Exercise in Cardiac Rehabilitation (Verdicchio et al., 2023). The intervention will include both aerobic and strength exercise. Examples of aerobic exercise include recumbent or upright cycling and treadmill (if appropriate). Examples of strength exercises include sit to stand, seated banded leg extensions, calf raises, dumbbell bicep curls and seated theraband rows. Exercise adherence in Phase 1 will be monitored by recording session attendance in an online database. In Phase 2, participants will be provided with a wearable fitness tracker (Polar Flow watch) to record their exercise session type and duration. The AEP will have access to their session data and will record this in an online database. This study will be conducted in patients 65 years old and above who have undergone a TAVR within the last three 6 months. Ideally participants will be recruited within 1-2 weeks post TAVR if deemed medically stable by the cardiologist and no post-operative complications have occurred. The research team will seek to commence the cardiac rehabilitation program for each participant as soon as possible after the baseline visit, noting that best practice for cardiac rehabilitation is early initiation after an event or hospitalisation.
Sponsors
University of Tasmania
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability and willingness to provide written informed consent to participate in the study 2. Safety - Adequate mobility (six minute walk test distance (6MWT) >100m), medical clearance from the referring cardiologist to exercise 3. Feasibility - Ability to attend eight weeks of supervised cardiac rehabilitation, and live within a geographically accessible area for follow-upPhase 1 (8 weeks) of supervised cardiac rehabilitation, and live within a geographically accessible area for follow-up
Exclusion criteria
1. The inability or willingness to provide written informed consent to participate in this study 2. Complications post TAVR e.g. infection or New York Heart Association (NYHA) Class IV heart failure 3. Other physical disability (non-cardiac) that would deem exercise participation unsafe 4. Active malignancy or other medical conditions resulting in a life expectancy < 12 months
Outcome results
None listed