Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370611
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-08
First Post:
2024-04-08
Brief Title:
Early Remote Rehabilitation to Improve Health of the Elderly After Cardiac Surgery RECARD Trial
Sponsor:
Ivy susanne Modrau MD
Organization:
Aarhus University Hospital Skejby
Study Overview
Official Title:
Early REmote Rehabilitation to Improve Health of the Elderly After CARDiac Surgery RECARD Trial A Bi-center Prospective Randomized Open-label Blinded Evaluation PROBE Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECARD
Brief Summary:
An increasing number of older patients undergo heart surgery Despite seemingly successful outcomes these vulnerable patients may face prolonged decreased functional capacity reduced self-efficacy and impaired quality of life after discharge Early engagement in physical activity and education plays a key role in health and well-being after heart surgery The goal of this clinical trial is to evaluate the effectiveness of an app-based exercise program and weekly calls from a physiotherapist in the early stages after open heart surgery
Eligible patients will be randomly assigned to either a control group receiving standard care or an intervention group which will be introduced to an individually tailored exercise program as an addition to standard care
Follow-up is planned with an out-patient visit six weeks after discharge and a telephone interview six months post-surgery
All participants will undergo assessments at enrollment and during follow-up Physical performance will be evaluated through physical tests General well-being quality of life self-reported physical activity and cost-effectiveness of the intervention will be assessed through questionnaires Muscle health will be examined through blood sampling CT scans and muscle biopsies
The primary endpoint is the 30-second Chair Stand Test serving as a measurement of physical function
Eligible patients will be randomly assigned to either a control group receiving standard care or an intervention group which will be introduced to an individually tailored exercise program as an addition to standard care
Follow-up is planned with an out-patient visit six weeks after discharge and a telephone interview six months post-surgery
All participants will undergo assessments at enrollment and during follow-up Physical performance will be evaluated through physical tests General well-being quality of life self-reported physical activity and cost-effectiveness of the intervention will be assessed through questionnaires Muscle health will be examined through blood sampling CT scans and muscle biopsies
The primary endpoint is the 30-second Chair Stand Test serving as a measurement of physical function
Detailed Description:
Hypotheses
Primary Early mobile health intervention at home supplemented by weekly calls from a physiotherapist after cardiac surgery improves functional outcomes exercise tolerance and quality of life in older patients
Secondary
Cardiac surgery increases the prevalence and extent of sarcopenia in the elderly which can be mitigated by early mobile health intervention
Sarcopenia on Chest Computed Tomography CCT is strongly correlated to functional outcome and quality of life following cardiac surgery
Early mobile health intervention is feasible and cost-effective
Design
This is a bi-center prospective randomized controlled parallel two-arm open-label blinded evaluation PROBE trial with a superiority design The study population will consist of a representative group n120 of older patients scheduled for open heart surgery who fulfill the requirements according to inclusion and exclusion criteria The patients will be recruited from 2 cardiac surgery centers in northern and central Denmark
Patients are stratified after center and subsequently randomly allocated 11 to receive mobile health intervention as an adjunct to standard care Intervention Group or standard care alone Control group for 6 weeks after discharge Follow-up is planned with an outpatient visit 6 weeks after discharge and a telephone interview 6 months after surgery
Patients in the intervention group receive a 6-week home-based CR using the ICURA app and sensor-based technology ICURA ApS Copenhagen Denmark During the hospital stay patients in the intervention group are introduced to the apps usage and an individualized training plan is collaboratively created and subsequently tailored by a physiotherapist The patients are equipped with a case including an ICURA -sensor with a charger an illustrative quick guide and a contact telephone number According to the patients preference the app is either installed on their own mobile phone or provided on a separate mobile device
The comprehensive mobile health intervention includes customized training programs activity tracking visualization of exercises with videos text message communication with patients and a password-protected webpage for physiotherapists to customize training programs and track patient activity
A few days after discharge patients in the intervention group will receive the first call from the physiotherapist to ensure that the patient is using the ICURA app actively The patients will receive two calls per week for the first two weeks and as required the following four weeks
Primary Early mobile health intervention at home supplemented by weekly calls from a physiotherapist after cardiac surgery improves functional outcomes exercise tolerance and quality of life in older patients
Secondary
Cardiac surgery increases the prevalence and extent of sarcopenia in the elderly which can be mitigated by early mobile health intervention
Sarcopenia on Chest Computed Tomography CCT is strongly correlated to functional outcome and quality of life following cardiac surgery
Early mobile health intervention is feasible and cost-effective
Design
This is a bi-center prospective randomized controlled parallel two-arm open-label blinded evaluation PROBE trial with a superiority design The study population will consist of a representative group n120 of older patients scheduled for open heart surgery who fulfill the requirements according to inclusion and exclusion criteria The patients will be recruited from 2 cardiac surgery centers in northern and central Denmark
Patients are stratified after center and subsequently randomly allocated 11 to receive mobile health intervention as an adjunct to standard care Intervention Group or standard care alone Control group for 6 weeks after discharge Follow-up is planned with an outpatient visit 6 weeks after discharge and a telephone interview 6 months after surgery
Patients in the intervention group receive a 6-week home-based CR using the ICURA app and sensor-based technology ICURA ApS Copenhagen Denmark During the hospital stay patients in the intervention group are introduced to the apps usage and an individualized training plan is collaboratively created and subsequently tailored by a physiotherapist The patients are equipped with a case including an ICURA -sensor with a charger an illustrative quick guide and a contact telephone number According to the patients preference the app is either installed on their own mobile phone or provided on a separate mobile device
The comprehensive mobile health intervention includes customized training programs activity tracking visualization of exercises with videos text message communication with patients and a password-protected webpage for physiotherapists to customize training programs and track patient activity
A few days after discharge patients in the intervention group will receive the first call from the physiotherapist to ensure that the patient is using the ICURA app actively The patients will receive two calls per week for the first two weeks and as required the following four weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None