Impact of cardiovascular rehabilitation and in TAVI (transcatheter aortic valve implantation) patients. Comparison with the impact of telerehabilitation as an alternative method in TAVI in Covid-19 era
| ISRCTN | ISRCTN32148715 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32148715 |
- Submission date
- 11/01/2023
- Registration date
- 10/02/2023
- Last edited
- 02/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Transcatheter aortic valve implantation (TAVI) is a surgery that is done to treat a narrowed heart valve. After the surgery, patients can do a program to help improve their heart health, called cardiovascular rehabilitation. Another way to do this program is through a computer or phone, called telerehabilitation. Some studies have shown that these programs can help patients feel better and live longer. This study wants to find out more about how these programs help patients by looking at how well their hearts work, and by measuring certain chemicals in their blood and doing pictures of their hearts.
Who can participate?
Elderly men and women, 60 to 85 years old, who will have undergone TAVI within a period of time 6 months before the start of the cardiovascular rehabilitation program, with a functional class of heart failure I to III, according to the functional classification of the New York Heart Association (NYHA). Patients should be under medication, have an ejection fraction (EF) ≥40%, and be able to perform mild-intensity exercise.
What does the study involve?
Participants will be randomly allocated to three groups. Group A (intervention group) will follow a combined exercise protocol (a 12-week combined program of aerobic exercise with strengthening). Group B (intervention group) will follow the same protocol but it will be home-based (telerehabilitation). Group C (control group) will follow a "usual treatment" protocol. The progress of the three groups will be monitored and recorded. Then the results of the three groups will be recorded and correlated.
What are the possible benefits and risks of participating?
There are no risks of participating in the study. The benefits of participating in the study are the improvement of symptoms and quality of life.
Where is the study run from?
University of West Attica (Greece)
When is the study starting and how long is it expected to run for?
January 2021 to December 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Maria Petridou, mpetridou@uniwa.gr
Contact information
Public
Androu 17, Vyronas
Athens
16233
Greece
 ORCID ID |
0000-0001-9274-467X |
|---|---|
| Phone | +30 (0)6975659601 |
| mpetridou@uniwa.gr |
Study information
| Study design | Single-centre randomized single-blind controlled parallel study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Comparative evaluation of cardiovascular rehabilitation programs in patients after transcutaneous aortic valve replacement; with evaluation of ergospirometric, functional, imaging and biochemical data and markers |
| Study acronym | CERIVA |
| Study objectives | The main hypothesis of the study is that the implementation of cardiovascular rehabilitation programs after transcutaneous aortic valve replacement (TAVI) improves parameters of ergospirometry, biochemical function, functional capacity and quality of life. In particular, results will be assessed in important indicators of functional capacity, such as peak oxygen uptake (VO₂peak), slope of respiratory equivalent for carbon dioxide (VE/VCO₂), in ultrasound (ejection fraction) and biochemical indices (BNP), in indices of cardiac function, such as heart rate recovery (HRR), while the results will also be investigated in patients' quality of life. |
| Ethics approval(s) | Approval pending, University of West Attica, Research Ethics Committee (28 Ag. Spyridonos Street, 12243 Egaleo, Greece; +30 (0)21053872948; ethics@uniwa.gr) |
| Health condition(s) or problem(s) studied | Cardiovascular rehabilitation in patients after TAVI |
| Intervention | Initially, the intervention will include a thorough medical examination, all relevant laboratory and diagnostic tests will be recorded, as well as pathological psychosocial factors and disorders. The first intervention group (group A) will follow a combined exercise protocol (a 12-week combined program of aerobic exercise with strengthening) and the second group (group B) the same protocol as A but taking place in the home of each patient under supervision (with modern means of communication - telerehabilitation). The control group (group C) will receive the usual treatment after TAVI (optimal medication, increased physical activity, correct healthy dietary habits). After the completion of the therapeutic interventions, a final re-evaluation will follow with measurement and recording of all parameters and variables (outcomes) under study, data will be collected and possible differences between the two groups will be investigated. Simple randomisation is used to assign participants to groups. |
| Intervention type | Mixed |
| Primary outcome measure | Measured at the initial visit and at the end of the study protocol: 1. Functional capacity will be measured using ergospirometric indicators as peak oxygen uptake (VO₂peak), respiratory equivalent slope for carbon dioxide (VE/VCO₂) 2. Survival rate will be assessed with the heart rate recovery index (HRR) 3. The effects of cardiac symptoms will be assessed with the SF-36 quality of life scale |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 10/01/2021 |
| Completion date | 30/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 60 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | Total: 75 participants (Each of the three study groups will include 25 participants) |
| Key inclusion criteria | 1. Men and women aged 60-85 years 2. Will have undergone TAVI within a period of time 6 months before starting the cardiovascular rehabilitation program 3. Functional class of heart failure I to III, according to the functional classification of the New York Heart Association (NYHA) 4. Patients will be under medication and should have an ejection fraction (EF) ≥40% 5. Willing to be assigned to the study |
| Key exclusion criteria | 1. Patients with severe-grade coronary artery disease 2. Genetic and non-genetic diseases that cause systolic or diastolic dysfunction 3. History of thromboembolic and vascular events diseases 4. Patients with an individual history of syncope fainting episodes and dangerous arrhythmias 5. Autoimmune patients or endocrinological diseases 6. Respiratory ailments 7. Neoplastic, hepatic, nephrological and infectious disease 8. Patients with disorders affecting the ability to exercise |
| Date of first enrolment | 01/02/2023 |
| Date of final enrolment | 01/06/2024 |
Locations
Countries of recruitment
- Greece
Study participating centre
Physiotherapy Department
School of Health and Caring Sciences
28 Ag. Spyridonos Street
Egaleo – Attica
12243
Greece
Sponsor information
University/education
Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM) Physiotherapy
Department School of Health and Caring Sciences
28 Ag. Spyridonos Street
Egaleo – Attica
12243
Greece
| Phone | +30 (0)210 5385228 |
|---|---|
| lanecasm@uniwa.gr | |
| Website | https://lanecasm.uniwa.gr |
"ROR" |
https://ror.org/00r2r5k05 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Individual participant data collected during the trial will be available after de-identification (text, tables, figures, and appendices), beginning 9 months and ending 36 months following article publication. Access will be granted to researchers who provide a methodologically sound proposal, in order for them to achieve the aims in the approved proposal. Proposals should be directed to Ms Maria Petridou (mpetridou@uniwa.gr). To gain access, data requestors will need to sign a data access agreement. After 36 months the data will not be applicable. During recruitment, patients are informed of the purposes of this study. Upon acceptance, and prior to baseline measurements, participants give their written informed consent (document in Greek). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | in Greek | 16/01/2023 | No | No |
Additional files
- 43034 Protocol (Greek).pdf
- in Greek
Editorial Notes
16/01/2023: Trial's existence confirmed by University of West Attica.
