Recruiting

Virtual PREHAB

Sponsor:

Nova Scotia Health Authority

Code:

NCT05617196

Conditions

Cardiovascular Diseases in Old Age

Frailty

TAVI

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Virtual PREHAB

Standard care

Study Details

Brief 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. 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

Study ID

NCT05617196

Start date

Jan 5, 2023

Status verified date

Aug, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Outpatients attending the TAVI clinic at the Queen Elizabeth II Health Sciences Centre
  • Informed written or verbal consent

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Care

experimental: Virtual PREHAB

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.

Interventions

Virtual PREHAB

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 care

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.

Primary outcome measure

  • CLSA-FI [ Time Frame: Baseline ]
  • CLSA-FI [ Time Frame: 8-weeks preoperatively ]
  • CLSA-FI [ Time Frame: 1-week preoperatively ]
  • CLSA-FI [ Time Frame: 3-months postoperatively ]
  • PFFS-FI [ Time Frame: Baseline ]
  • PFFS-FI [ Time Frame: 1-week preoperatively ]
  • PFFS-FI [ Time Frame: 8-weeks preoperatively ]
  • PFFS-FI [ Time Frame: 3-months postoperatively ]

Central Contacts and Locations

Central contacts

Scott Kehler, PhD

902-494-2822scott.kehler@dal.ca

Locations

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada, B4E 0H4

Contacts

Scott Kehler

902-494-2822scott.kehler@dal.ca

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 21, 2024

Last verified

Aug, 2024

Keywords

  • Frailty
  • Virtual PREHAB
  • Cardiac rehabilitation
  • TAVI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-08-21.