Status:
COMPLETED
BioTechCOACH-ForALL: Development of Mental and Physical Exercise Systems, Clinical Recording, Supervisory Analytical Large-scale Data and Virtual Guidance of Vulnerable Population Groups
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Heart Failure
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
This would be a single center, parallel, two group randomized controlled pilot study that is designed to assess the feasibility and efficacy of the Virtual Coach Program in elderly patients with heart...
Detailed Description
This would be a single center, parallel, two group randomized controlled pilot study that is designed to assess the feasibility and efficacy of the Virtual Coach Program in elderly patients with heart...
Eligibility Criteria
Inclusion
- Male and female patients aged \>55 years old with any of the following conditions, diagnosed according to appropriate international guidelines criteria
- a) Heart failure of any etiology, with either reduced or preserved ejection fraction
- Subjects must be in WHO Functional Class II-IV
- Subjects must be on stable clinical condition and on stable medical treatment for the underlying disease for at least three months prior to randomization
- Willing and able to comply with scheduled visits, treatment plan, and trial procedures
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
Exclusion
- Patients with heart conditions other that those listed above
- Subjects who have unstable disease with evidence of decompensation, recent hospitalization or undergoing investigation for clinical deterioration
- Subjects with recent history of chest pain, palpitations, lightheadedness, dizziness, or syncope on exertion
- Subjects with contraindications to physical activity or with physical obstruction to perform the prescribed training program (eg patients confined on wheel chair etc)
- Subjects with any severe acute or chronic medical or psychiatric condition that may increase the risk associated with trial participation or may interfere with the interpretation of trial results
- Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator
- Subjects participating in any other experimental studies
- Subjects not willing to provide signed informed consent.
Key Trial Info
Start Date :
July 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03877328
Start Date
July 18 2018
End Date
April 30 2020
Last Update
March 3 2021
Active Locations (2)
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1
AHEPA University Hospital of Thessaloniki
Thessaloniki, Greece
2
Laboratory of Medical Physics, AUTH
Thessaloniki, Greece