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

NCT06370611 | Enrolling By Invitation DMC

• 1 other identifier: 2314027
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiac Rehabilitation

Keywords

Cardiac Surgery; Mobile Health; Elderly; Exercise; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (16)

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

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

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

  6 weeks (+/- 4 days) after discharge

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

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

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

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

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

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

Study Arms (2)

Early mobile health intervention

ACTIVE COMPARATOR

ICURA 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

Control

NO INTERVENTION

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.

Interventions

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.

Also known as: ICURA

Early mobile health intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Scheduled first-time heart surgery through median sternotomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Ivy susanne Modrau, MD: lead
• Aalborg University Hospital: collaborator

Study Sites (2)

Aarlborg University Hospital

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40600679 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ivy S. Modrau, MD, dr.med.

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Allocation cannot be concealed from the participants, care providers or investigator. Outcome assessors will be blinded regarding allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Med., Consultant Cardiac Surgon, Associate Professor

Model Details: Bi-center, prospective, randomized, controlled, parallel (1:1), two-arm, open-label, blinded evaluation (PROBE) trial

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 17, 2024
• Study Start: May 1, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)