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Completed

NCT Number: NCT03877328

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

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.

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Heart Diseases Motor Activity

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AHEPA University Hospital of Thessaloniki, Thessaloniki, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BiotechCoachForAll

Other

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.

Primary outcomes

  1. The subjects' functionality assessed both prior intervention and at the end of the study

    Time frame: 3 months

    Functional capacity assessed by WHO functional class

  2. The subjects' exercise intolerance assessed both prior intervention and at the end of the study

    Time frame: 3 months

    Exercise intolerance assessed by distance walked in six-minute walk test

  3. The subjects' quality of life assessed both prior intervention and at the end of the study

    Time frame: 3 months

    Health related quality of life assessed with the use of properly weighed for the Greek language questionnaires

    -SF-36 questionnaire

  4. The subjects' quality of life assessed both prior intervention and at the end of the study

    Time frame: 3 months

    Health related quality of life assessed with the use of properly weighed for the Greek language questionnaires

    -Dukes questionnaire

  5. Hospitalization

    Time frame: 3 months

    The number of hospital admissions

  6. Healthcare usage

    Time frame: 3 months

    The healthcare usage expressed by the relevant medical assistance usage

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 15, 2019
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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