BioTechCOACH-ForALL: Development of Mental and Physical Exercise Systems, Clinical Recording, Supervisory Analytical Large-scale Data and Virtual Guidance of Vulnerable Population Groups

Study Overview
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Brief Summary
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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 failure.

Detailed Description
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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 failure. Sixteen (16) subjects will be enrolled to allow 8 subjects to be randomly assigned to each arm. The study will be conducted in Thessaloniki/Greece. The study is expected to complete enrollment in approximately 3 months. Participants will be randomly randomized to either the intervention group (use of Virtual Coach program and usual care) or the control group (use of usual care alone) after successfully fulfilling all inclusion and exclusion criteria.

Official Title
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BioTechCOACH-ForALL: Development of Mental and Physical Exercise Systems, Clinical Recording, Supervisory Analytical Large-scale Data and Virtual Guidance of Vulnerable Population Groups

Conditions
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Heart Failure

Intervention / Treatment
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* Other: BiotechCoachForAll


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Coach<br>BiotechCoachForAll | Other: BiotechCoachForAll<br>* A group of thirty subjects diagnosed with heart failure (HF) of any etiology undergo an experimental procedure in the following order: resting-state (eyes-closed), passively viewing thirty two agents which are grouped with respect to different appearance characteristics and passively viewing combinations of virtual agents. During the experiment, brain activity, heart rate, skin conductance, temperature and eye-gaze biosignals are collected by means of electroencephalography, Empatica E4 and Gazepoint. Subsequently, a prospective cohort study is performed in a subgroup of ten participants which undergo a three additive stage procedure. Stage 1, a wearable monitoring device (Wavelet Health) is given in order to provide objective information on the patient's activity. Stage 2, the FitForAll physical exercise program is introduced. Stage 3, introduces the coaching aspects, where personalized recommendations and suggestions are delivered through home surfaces' projection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The subjects' functionality assessed both prior intervention and at the end of the study | Functional capacity assessed by WHO functional class | 3 months | 
| The subjects' exercise intolerance assessed both prior intervention and at the end of the study | Exercise intolerance assessed by distance walked in six-minute walk test | 3 months | 
| The subjects' quality of life assessed both prior intervention and at the end of the study | Health related quality of life assessed with the use of properly weighed for the Greek language questionnaires -SF-36 questionnaire | 3 months | 
| The subjects' quality of life assessed both prior intervention and at the end of the study | Health related quality of life assessed with the use of properly weighed for the Greek language questionnaires -Dukes questionnaire | 3 months | 
| Hospitalization | The number of hospital admissions | 3 months | 
| Healthcare usage | The healthcare usage expressed by the relevant medical assistance usage | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, exercise, life coach