Cardiovascular Diseases in Old AgeNCT05617196
Virtual PREHAB Study for Patients Undergoing TAVI
A study testing Virtual PREHAB in people with Cardiovascular Diseases in Old Age and Frailty, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Nova Scotians are aging and many are becoming frailer. People with frailty are more likely to live in worse health and do not recover well from major events, such as open heart surgery. Many people are also too frail to receive open heart surgery. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Cardiovascular Diseases in Old Age, Frailty, TAVI
- What is being tested?
- Virtual PREHAB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients attending the TAVI clinic at the Queen Elizabeth II Health Sciences Centre
- Informed written or verbal consent
Who cannot join
- New York Heart Association or Canadian Cardiovascular Score of 4
- Severe functional limitations
- Cognitive impairment that impacts consenting ability
- Significant language barrier
- No internet or telephone access that precludes virtual PREHAB participation
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Health
Halifax, Nova Scotia, B4E 0H4
Scott Kehler, 902-494-2822, scott.kehler@dal.ca
About this study
Official title: Feasibility of a Virtually Delivered Preoperative Rehabilitation Program for Patients Awaiting TAVI to Reduce Frailty: The Virtual PREHAB Study
Nova Scotians are aging and many are becoming frailer. People with frailty are more likely to live in worse health and do not recover well from major events, such as open heart surgery. Many people are also too frail to receive open heart surgery. Less invasive procedures called transcatheter aortic valve implantation, or TAVI, are provided for the frailest patients. While TAVI is life-saving, frailer patients are less likely to survive in better health after their operation. Patients in Nova Scotia can also wait up to 3-6 months for their operation where they become frailer or can die before receiving TAVI. The investigators believe that it is important to support these individuals to improve their frailty and overall health before their operation.
Center-based cardiac rehabilitation is offered to patients after, but not before TAVI to improve their health. Center-based preoperative cardiac rehabilitation (i.e., PREHAB) can safely improve the function of frail patients who received open heart surgery. However, many patients cannot come to a center-based PREHAB because of transportation requirements to access the program. Another option is to support these patients with virtually delivered PREHAB, where they can stay in their homes. However, this possibility has not been studied.
For this study, virtual PREHAB will be delivered using the virtual cardiac rehabilitation program in Nova Scotia to patients before TAVI. This intervention will be delivered by healthcare providers who routinely care for TAVI patients, including a medical director, program lead, nurse, physiotherapist, and dietician. Ther goal of this study is to determine if it is feasible and safe to use virtual PREHAB to reduce frailty before TAVI. This research fits with Research Nova Scotia's priorities to improve patient outcomes in those with significant long-term health conditions, and to provide accessible, safe, and quality virtual healthcare to patients so they can thrive after their operation.
- Conditions
- Cardiovascular Diseases in Old Age, Frailty, TAVI
- Being tested
- Virtual PREHAB, Standard care
- Keywords
- Frailty, Virtual PREHAB, Cardiac rehabilitation, TAVI
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual PREHABBehavioural
The Virtual PREHAB program begins with a virtual health care team assessment. The physiotherapist will support patients in identifying ways to safely engage in home-based physical activities and in their neighborhoods. Additional weekly 30-minute telephone consultations with the physiotherapist, nurse, and dietitian are provided as well as three 30-minute online consultations are provided; telephone calls will replace these online consults if the patient does not have internet access. Telephone and/or online consults with participants will monitor the progression of the individual through the program, review patient materials, review medication changes, as well as provide recommendations to adopting a physically active lifestyle, diet, well-being, smoking, or other supports available to the patient. Medication changes are monitored by a nurse and any necessary medication recommendations involve the program's medical director, the patient's family physician, and TAVI team.
Standard careBehavioural
In Nova Scotia, patients are referred to the TAVI program. The TAVI health care team, consisting of a cardiac surgeon, cardiologist, nurse, and geriatric team conduct patient assessments and provide guidance and resources on self management.Once patient assessments are completed, patients are discussed at a multidisciplinary team meeting. When a patient is accepted for TAVI, they are placed on a waiting list which lasts for 3-6 months depending on urgency.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Not described Receives: Behavioral: Standard care |
| Virtual PREHAB | Experimental | In addition to standard care, participants randomized to the The virtual PREHAB program will be delivered by the Hearts and Health in Motion cardiac rehabilitation CR health care team including a medical director nurse, dietician, and physiotherapist who routinely deliver CR postoperatively. The virtual PREHAB program will be up to 8-weeks in duration and deliver the core components of CR online or by telephone. Receives: Behavioral: Virtual PREHAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLSA-FI
Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
Measured: Baseline
CLSA-FI
Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
Measured: 8-weeks preoperatively
CLSA-FI
Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
Measured: 1-week preoperatively
CLSA-FI
Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
Measured: 3-months postoperatively
PFFS-FI
Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)
Measured: Baseline
PFFS-FI
Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)
Measured: 1-week preoperatively
PFFS-FI
Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)
Measured: 8-weeks preoperatively
PFFS-FI
Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)
Measured: 3-months postoperatively
Secondary outcomes (7)
EQ-5D-5L health-related quality of life
Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
Measured: Baseline
EQ-5D-5L health-related quality of life
Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
Measured: 8-weeks preoperatively
EQ-5D-5L health-related quality of life
Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
Measured: 1-week preoperatively
EQ-5D-5L health-related quality of life
Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
Measured: 3-months postoperatively
VARC-3 Composite clinical end-points
Valvular Academic Research Consortium V.3.0 clinical endpoints (Mortality, Neurologic events, Hospitalization, Rehospitalization, Bleeding and transfusions, Vascular and access-related complications, Cardiac structural complications, Other procedural or valve-related complications, New conduction disturbances and arrhythmias, New conduction disturbances and arrhythmias, Myocardial infarction, Bioprosthetic valve dysfunction, Leaflet thickening and reduced motion, Clinically significant valve thrombosis, Patient-reported outcomes and health status. Fewer complications indicate a better surgical outcome
Measured: Hospital discharge (assessed up to day 14)
VARC-3 Composite clinical end-points
Valvular Academic Research Consortium V.3.0 clinical endpoints (Mortality, Neurologic events, Hospitalization, Rehospitalization, Bleeding and transfusions, Vascular and access-related complications, Cardiac structural complications, Other procedural or valve-related complications, New conduction disturbances and arrhythmias, New conduction disturbances and arrhythmias, Myocardial infarction, Bioprosthetic valve dysfunction, Leaflet thickening and reduced motion, Clinically significant valve thrombosis, Patient-reported outcomes and health status. Fewer complications indicate a better surgical outcome
Measured: 30-days postoperatively
Cardiac rehabilitation attendance
Percent of people attending cardiac rehabilitation
Measured: 3-months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start5 Jan 2023
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617196
- Sponsor's protocol ID
- NS-NHIG-2021-1905
- Status last verified
- Aug 2024
- First submitted
- 26 Oct 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Virtually Delivered Preoperative Rehabilitation Program for Patients Awaiting TAVI to Reduce Frailty: The Virtual PREHAB Study
- ClinicalTrials.gov ID
- NCT05617196
- Acronym / sponsor ID
- NS-NHIG-2021-1905
- Conditions
- Cardiovascular Diseases in Old Age, Frailty, TAVI
- Keywords
- Frailty, Virtual PREHAB, Cardiac rehabilitation, TAVI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nova Scotians are aging and many are becoming frailer. People with frailty are more likely to live in worse health and do not recover well from major events, such as open heart surgery. Many people are also too frail to receive open heart surgery. Less invasive procedures called transcatheter aortic valve implantation, or TAVI, are provided for the frailest patients. While TAVI is life-saving, frailer patients are less likely to survive in better health after their operation. Patients in Nova Scotia can also wait up to 3-6 months for their operation where they become frailer or can die before receiving TAVI. The investigators believe that it is important to support these individuals to improve their frailty and overall health before their operation.
Center-based cardiac rehabilitation is offered to patients after, but not before TAVI to improve their health. Center-based preoperative cardiac rehabilitation (i.e., PREHAB) can safely improve the function of frail patients who received open heart surgery. However, many patients cannot come to a center-based PREHAB because of transportation requirements to access the program. Another option is to support these patients with virtually delivered PREHAB, where they can stay in their homes. However, this possibility has not been studied.
For this study, virtual PREHAB will be delivered using the virtual cardiac rehabilitation program in Nova Scotia to patients before TAVI. This intervention will be delivered by healthcare providers who routinely care for TAVI patients, including a medical director, program lead, nurse, physiotherapist, and dietician. Ther goal of this study is to determine if it is feasible and safe to use virtual PREHAB to reduce frailty before TAVI. This research fits with Research Nova Scotia's priorities to improve patient outcomes in those with significant long-term health conditions, and to provide accessible, safe, and quality virtual healthcare to patients so they can thrive after their operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Standard care |
| Virtual PREHAB | Experimental | Behavioral: Virtual PREHABIn addition to standard care, participants randomized to the The virtual PREHAB program will be delivered by the Hearts and Health in Motion cardiac rehabilitation CR health care team including a medical director nurse, dietician, and physiotherapist who routinely deliver CR postoperatively. The virtual PREHAB program will be up to 8-weeks in duration and deliver the core components of CR online or by telephone. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatients attending the TAVI clinic at the Queen Elizabeth II Health Sciences Centre
- Informed written or verbal consent
Key exclusion criteria (5 listed)
- New York Heart Association or Canadian Cardiovascular Score of 4
- Severe functional limitations
- Cognitive impairment that impacts consenting ability
- Significant language barrier
- No internet or telephone access that precludes virtual PREHAB participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual PREHABThe Virtual PREHAB program begins with a virtual health care team assessment. The physiotherapist will support patients in identifying ways to safely engage in home-based physical activities and in their neighborhoods. Additional weekly 30-minute telephone consultations with the physiotherapist, nurse, and dietitian are provided as well as three 30-minute online consultations are provided; telephone calls will replace these online consults if the patient does not have internet access. Telephone and/or online consults with participants will monitor the progression of the individual through the program, review patient materials, review medication changes, as well as provide recommendations to adopting a physically active lifestyle, diet, well-being, smoking, or other supports available to the patient. Medication changes are monitored by a nurse and any necessary medication recommendations involve the program's medical director, the patient's family physician, and TAVI team. | Behavioural | Virtual PREHAB |
| Standard careIn Nova Scotia, patients are referred to the TAVI program. The TAVI health care team, consisting of a cardiac surgeon, cardiologist, nurse, and geriatric team conduct patient assessments and provide guidance and resources on self management.Once patient assessments are completed, patients are discussed at a multidisciplinary team meeting. When a patient is accepted for TAVI, they are placed on a waiting list which lasts for 3-6 months depending on urgency. | Behavioural | Standard Care |
Primary outcome
CLSA-FI
Time frame: Baseline
Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
CLSA-FI
Time frame: 8-weeks preoperatively
Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
CLSA-FI
Time frame: 1-week preoperatively
Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
CLSA-FI
Time frame: 3-months postoperatively
Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
PFFS-FI
Time frame: Baseline
Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)
PFFS-FI
Time frame: 1-week preoperatively
Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)
PFFS-FI
Time frame: 8-weeks preoperatively
Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)
PFFS-FI
Time frame: 3-months postoperatively
Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)
7 secondary outcomes
EQ-5D-5L health-related quality of life
Time frame: Baseline
EQ-5D-5L health-related quality of life
Time frame: 8-weeks preoperatively
EQ-5D-5L health-related quality of life
Time frame: 1-week preoperatively
EQ-5D-5L health-related quality of life
Time frame: 3-months postoperatively
VARC-3 Composite clinical end-points
Time frame: Hospital discharge (assessed up to day 14)
VARC-3 Composite clinical end-points
Time frame: 30-days postoperatively
Cardiac rehabilitation attendance
Time frame: 3-months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Diseases in Old Age
Recruiting
Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?
Cardiovascular Diseases in Old Age
Recruiting
Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study
Breast Cancer Female, Cardiometabolic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual PREHAB in people with Cardiovascular Diseases in Old Age and Frailty, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott Kehler, PhD (902-494-2822, scott.kehler@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLSA-FI (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024; AzTrials last refreshed its copy on 26 Oct 2026.