Early Remote Rehabilitation to Improve Health of the Elderly After Cardiac Surgery. (RECARD Trial) (RECARD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Device: Early mobile health intervention supplemented by weekly calls from a physiotherapist

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 (n=120) 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 (1:1) 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 Activity app and sensor-based technology (ICURA ApS, Copenhagen, Denmark). During the hospital stay patients in the intervention group are introduced to the app's 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 Activity-sensor with a charger, an illustrative quick guide, and a contact telephone number. According to the patient's 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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivy S. Modrau, MD, dr.med.; Phone Number: +45 24778856; Email: ivymod@clin.au.dk
• Study Contact Backup: Name: Rikke Daugaard, PT, MHSc; Phone Number: +45 41282266; Email: daugaard@clin.au.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aarlborg University Hospital
    • Contact: Stian Ingemann-Molden, PT, MHSc; Phone Number: +45 97664210; Email: s.ingemannmolden@rn.dk
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
    • Contact: Rikke Daugaard, PT, MHSc; Phone Number: +45 41282266; Email: daugaard@clin.au.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form
• Scheduled first-time heart surgery through median sternotomy
• Male or female, aged ≥ 65 years (The age criterion implies the exclusion of women of childbearing potential)
• Available Cardiac-CT (< 3 months)

Exclusion Criteria:

• Medical conditions requiring referral to specialized rehabilitation (e.g., severe heart or lung failure, need for blood pressure monitoring during exercise)
• Emergent procedure
• Anticipated inability to perform intervention, study assessment procedures, or follow-up
• Participation in any other interventional clinical that may interfere with the outcome measures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early mobile health intervention; ICURA Activity app and sensor-based technology, individualized training plan, and weekly calls from a physiotherapist in addition to standard care	Device: Early mobile health intervention supplemented by weekly calls from a physiotherapist; Six-week home-based rehabilitation program using the ICURA Activity app and sensor-based technology (ICURA ApS, Copenhagen, Denmark). During the hospital stay patients in the intervention group are introduced to the app's usage, and an individualized training plan is collaboratively created and subsequently tailored by a physiotherapist. The comprehensive mobile health intervention includes customized training programs, activity tracking, visualization of exercises with videos, and a password-protected webpage for physiotherapists to customize training programs and track patient activity. The patients will receive two calls from a physiotherapist per week for the first two weeks and as required the following four weeks.; Other Names: ICURA Activity
No Intervention: Control; Standard care consists of physiotherapy group education of about 10-15 minutes regarding mobilization, respiratory therapy, and sternal precautions after surgery. After surgery, phase I in-hospital rehabilitation consists of respiratory therapy, mobilization from supine and sitting position, and walking down a corridor. Prior to discharge, all patients are encouraged to undertake daily walks and resume activities of daily living, and engage in recommended moderate physical activity (Borg's scale 12-14). All patients are referred to CR in their municipality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (Δ) 30-second chair stand test (30CST) baseline vs. 6-week FU	Recording of the number of stands a person can complete from a chair without arms in 30 seconds	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (Δ) in 10-meter Walk Test (10MWT) baseline vs. 6-week FU	Measurement of walking speed in meters per second over a 10-meter distance	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery
Difference in 6-minute Walk Test (6MWT) between groups at 6-week FU	Measurement of walking distance in 6 minutes.	6 weeks (+/- 4 days) after surgery
Change (Δ) in WHO-5-score baseline vs. 6-week FU	5-item World Health Organization Well-Being Index (WHO-5), questionnaire assessing subjective well-being	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery and 6 months after surgery
Change (Δ) in ASS-2-score baseline vs. 6-week FU	Anxiety Symptom Scale-2 (ASS-2), questionnaire assessing anxiety	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery and 6 months after surgery
Change (Δ) in MDI-2-score baseline vs. 6-week FU	Major Depression Inventory-2 (MDI-2), questionnaire assessing depression	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery and 6 months after surgery
Change (Δ) in Self-reported Physical Activity baseline vs. 6-week FU	Questionnaire assessing self-reported physical activity	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery and 6 months after surgery
Change (Δ) in EuroQol-score baseline vs. 6-week FU	EuroQol-5-Dimension-5-Level Questionnaire (EQ-5D-5L), questionnaire assessing health-related quality of life	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery and 6 months after surgery
Change in skeletal muscle mass maximum 3 months prior to surgery vs. 6-week FU	Body composition analysis with artificial-intelligence-assisted medical image analysis (CT scan) (DAFS©, Veronoi Health Analytics, Vancouver, Canada) to assess quantity and quality of skeletal muscle.	Maximum 3 months prior to surgery and 6 weeks (+/- 4 days) after surgery
Cost-effectiveness analysis	Questionnaire assessing the cost-effectiveness of the intervention in comparison to usual care	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery and 6 months after surgery
Changes in markers of musculoskeletal health through blood samples baseline vs. 6-week FU	Markers of muscle health: Myoglobin, Creatine Kinase (CK)	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery
Changes in markers of inflammation through blood samples baseline vs. 6-week FU	Inflammatory markers: White Cell Count (WCC), Platelet Count, Mean Platelet Volume (MPV), Immature Platelet Fraction (IPF), High-Sensitive C-Reactive Protein (hs-CRP)	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery
Changes in markers of nutrition through blood samples baseline vs. 6-week FU	Nutritional markers: Hemoglobin, Glycated Hemoglobin (HbA1c), fasting glucose, Albumin, Triglycerides, High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), Vitamin B12, Folate, 25-OH-Vitamin D2+D3	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery
Changes in markers of liver function through blood samples baseline vs. 6-week FU	Liver Function Markers: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT)	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery
Changes in markers of kidney function through blood samples baseline vs. 6-week FU	Kidney Function Markers: Creatinine, estimated Glomerular Filtration Rate (eGFR)	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery
Changes in markers of hormone levels through blood samples baseline vs. 6-week FU	Hormonal Markers: Cortisol, Free/Total Testosterone, Sex Hormone Binding Globulin (SHBG), Insulin-like Growth Factor-1 (IGF-1)	1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery

Collaborators and Investigators

• Sponsor: Ivy susanne Modrau, MD
• Collaborators: Aalborg University Hospital
• Investigators: Study Chair: Ivy S. Modrau, MD, dr.med., Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; Exercise; Mobile Health; Cardiac Surgery; Randomised Controlled Trial
• Other Study ID Numbers: 2314027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The participants of this study did not give written consent for their data to be shared publicly, so due to the sensitive nature of the research supporting data is not available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No