Status:

COMPLETED

Effectiveness of the Aktivplan Digital Intervention (ACTIVE-CaRe Pilot)

Lead Sponsor:

Ludwig Boltzmann Institute for Digital Health and Prevention

Collaborating Sponsors:

REHA Zentrum Salzburg

Reha-Klinik Montafon

Conditions:

Cardiac Rehabilitation

Secondary Prevention

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The goal of this clinical pilot / feasibility study is to determine the feasibility of conducting a large-scale clinical effectiveness trial of the aktivplan digital intervention in cardiac rehabilita...

Eligibility Criteria

Inclusion

  • Enrollment to a cardiac rehabilitation programme phase II, or a rehabilitation programme phase II due to non-cardiac indication but displaying cardiovascular risk factors
  • Ownership and use of a smartphone compatible with the aktivplan digital intervention and with internet connection
  • Agreement to attend the study follow-up visit
  • Written informed consent to take part in the study

Exclusion

  • Existing use of a digital intervention for regular heart-healthy physical activity
  • Medical contraindications for incremental cycle ergometry test
  • Medical contraindications for regular heart-healthy physical activity and sports
  • Medical contraindications for use of a smartphone
  • Inability to carry out cardiovascular training (e.g., due to significant musculoskeletal restrictions)
  • Participation in another clinical study within the past 6 months
  • Addiction or other medical conditions causing reduced decisional capacity
  • Pregnant women in the third trimester
  • Pregnant women in the first and second trimester with medical contraindication for physical activity and sports
  • Breastfeeding women with medical contraindication for physical activity and sports
  • Indication that patient is unlikely to follow study procedures (limited cooperation)

Key Trial Info

Start Date :

October 2 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 31 2024

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT06025526

Start Date

October 2 2023

End Date

August 31 2024

Last Update

October 9 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

REHA Zentrum Salzburg

Salzburg, Salzburg, Austria, 5020

2

Reha-Klinik Montafon

Schruns, Vorarlberg, Austria, 6780