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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

2. marts 2021 opdateret af: Panos Bamidis, Aristotle University Of Thessaloniki
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Thessaloniki, Grækenland
        • Laboratory of Medical Physics, AUTH
      • Thessaloniki, Grækenland
        • AHEPA University Hospital of Thessaloniki

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. 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

  2. Subjects must be in WHO Functional Class II-IV
  3. Subjects must be on stable clinical condition and on stable medical treatment for the underlying disease for at least three months prior to randomization
  4. Willing and able to comply with scheduled visits, treatment plan, and trial procedures
  5. 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:

  1. Patients with heart conditions other that those listed above
  2. Subjects who have unstable disease with evidence of decompensation, recent hospitalization or undergoing investigation for clinical deterioration
  3. Subjects with recent history of chest pain, palpitations, lightheadedness, dizziness, or syncope on exertion
  4. Subjects with contraindications to physical activity or with physical obstruction to perform the prescribed training program (eg patients confined on wheel chair etc)
  5. 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
  6. 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
  7. Subjects participating in any other experimental studies
  8. Subjects not willing to provide signed informed consent.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Virtual Coach
BiotechCoachForAll
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The subjects' functionality assessed both prior intervention and at the end of the study
Tidsramme: 3 months
Functional capacity assessed by WHO functional class
3 months
The subjects' exercise intolerance assessed both prior intervention and at the end of the study
Tidsramme: 3 months
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
Tidsramme: 3 months

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
Tidsramme: 3 months

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

-Dukes questionnaire

3 months
Hospitalization
Tidsramme: 3 months
The number of hospital admissions
3 months
Healthcare usage
Tidsramme: 3 months
The healthcare usage expressed by the relevant medical assistance usage
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Panagiotis Bamidis, PhD, Associate professor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. juli 2018

Primær færdiggørelse (Faktiske)

30. april 2020

Studieafslutning (Faktiske)

30. april 2020

Datoer for studieregistrering

Først indsendt

19. februar 2019

Først indsendt, der opfyldte QC-kriterier

14. marts 2019

Først opslået (Faktiske)

15. marts 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MIS5005517

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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