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Enrolling by Invitation

NCT Number: NCT06370611

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

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Key information

Conditions

Cardiac Rehabilitation Behavior Motor Activity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarlborg University Hospital, Aalborg, Denmark

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About this study

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 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 -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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

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

Treatment and study plan

Early mobile health intervention supplemented by weekly calls from a physiotherapist

Device

Six-week home-based rehabilitation program 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 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

Primary outcomes

  1. Change (Δ) 30-second chair stand test (30CST) baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after surgery

    Recording of the number of stands a person can complete from a chair without arms in 30 seconds

Secondary outcomes

  1. Change (Δ) in 10-meter Walk Test (10MWT) baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge

    Measurement of walking speed in meters per second over a 10-meter distance

  2. Difference in 6-minute Walk Test (6MWT) between groups at 6-week FU

    Time frame: 6 weeks (+/- 4 days) after discharge

    Measurement of walking distance in 6 minutes.

  3. Change (Δ) in WHO-5-score baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery

    5-item World Health Organization Well-Being Index (WHO-5), questionnaire assessing subjective well-being

  4. Change (Δ) in ASS-2-score baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery

    Anxiety Symptom Scale-2 (ASS-2), questionnaire assessing anxiety

  5. Change (Δ) in MDI-2-score baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery

    Major Depression Inventory-2 (MDI-2), questionnaire assessing depression

  6. Change (Δ) in Self-reported Physical Activity baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery

    Questionnaire assessing self-reported physical activity

  7. Change (Δ) in EuroQol-score baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery

    EuroQol-5-Dimension-5-Level Questionnaire (EQ-5D-5L), questionnaire assessing health-related quality of life

  8. Change in skeletal muscle mass baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge

    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.

  9. Cost-effectiveness analysis

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge and 6 months after surgery

    Questionnaire assessing the cost-effectiveness of the intervention in comparison to usual care

  10. Changes in markers of musculoskeletal health through blood samples baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge

    Markers of muscle health: Myoglobin, Creatine Kinase (CK)

  11. Changes in markers of inflammation through blood samples baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge

    Inflammatory markers: White Cell Count (WCC), Platelet Count, Mean Platelet Volume (MPV), Immature Platelet Fraction (IPF), High-Sensitive C-Reactive Protein (hs-CRP)

  12. Changes in markers of nutrition through blood samples baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge

    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

  13. Changes in markers of liver function through blood samples baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge

    Liver Function Markers: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT)

  14. Changes in markers of kidney function through blood samples baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge

    Kidney Function Markers: Creatinine, estimated Glomerular Filtration Rate (eGFR)

  15. Changes in markers of hormone levels through blood samples baseline vs. 6-week FU

    Time frame: 1-7 days prior to surgery and 6 weeks (+/- 4 days) after discharge

    Hormonal Markers: Cortisol, Free/Total Testosterone, Sex Hormone Binding Globulin (SHBG), Insulin-like Growth Factor-1 (IGF-1)

  16. Assessment of muscle quality through obtainment of biopsies of the pectoralis major muscle at the surgery

    Time frame: At surgery

    Analysis of pectoralis major muscle biopsies

Sponsors and collaborators

Lead sponsor

Ivy susanne Modrau, MD

Other

Collaborators

  • Aalborg University Hospital

Registry information

Official study 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

Acronym: RECARD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 17, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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