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Cardiac RehabilitationRECARDNCT06370611

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

A study testing Early mobile health intervention supplemented by weekly calls from a physiotherapist in people with Cardiac Rehabilitation, run by Ivy susanne Modrau, MD at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Cardiac Rehabilitation
What is being tested?
Early mobile health intervention supplemented by weekly calls from a physiotherapist
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
2 sitesDenmark
Study dates
1 May 2024to 15 Aug 2026
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites
  • Aarlborg University Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, Denmark, 8200

Other trials in Denmark

About this study

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

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.

Read more

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.

Read the 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 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.

Being tested
Early mobile health intervention supplemented by weekly calls from a physiotherapist
Keywords
Cardiac Surgery, Mobile Health, Elderly, Exercise, Randomised Controlled Trial
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early mobile health intervention supplemented by weekly calls from a physiotherapistDevice

    Also called ICURA

    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.

Study groups in NCT06370611
Study groupRoleWhat they receive
Early mobile health interventionActive comparatorICURA app and sensor-based technology, individualized training plan, and weekly calls from a physiotherapist in addition to standard care
Receives: Device: Early mobile health intervention supplemented by weekly calls from a physiotherapist
ControlNo interventionStandard 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

Secondary outcomes (16)
  1. 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

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

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

    Measurement of walking distance in 6 minutes.

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

  3. 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

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

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

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

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

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

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

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

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

    Questionnaire assessing self-reported physical activity

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

  7. 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

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

  8. Change in skeletal muscle mass baseline 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.

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

  9. Cost-effectiveness analysis

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

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

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

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

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

  11. 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)

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

  12. 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

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

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

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

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

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

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

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

  15. 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)

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

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

    Analysis of pectoralis major muscle biopsies

    Measured: At surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2024
  2. Study start1 May 2024
  3. Primary completion15 Mar 2026
  4. Study completion15 Aug 2026

Resources

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
Model description
Bi-center, prospective, randomized, controlled, parallel (1:1), two-arm, open-label, blinded evaluation (PROBE) trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06370611
Sponsor's protocol ID
2314027
Acronym
RECARD
Status last verified
Sep 2026
First submitted
8 Apr 2024
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Svidt P, Daugaard R, Lading T, Modrau IS. Changes in skeletal muscle and physical function after cardiac surgery: a prospective study. J Nutr Health Aging. 2026 Oct 3;30(12):100999. doi: 10.1016/j.jnha.2026.100999. Online ahead of print.

    PubMed 42828917
  • Daugaard R, Sorensen L, Ingemann-Molden S, Modrau IS. Early remote rehabilitation to improve health of the elderly after cardiac surgery - study protocol for a randomised trial. Dan Med J. 2025 Jun 21;72(7):A11240820. doi: 10.61409/A11240820.

    PubMed 40600679

Questions about this trial

What is this clinical trial studying?

A study testing Early mobile health intervention supplemented by weekly calls from a physiotherapist in people with Cardiac Rehabilitation, run by Ivy susanne Modrau, MD at 2 sites in Denmark.

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06370611, which also lists 2 linked publications.

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 9 Sep 2026.

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