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

NCT03877328 | Completed

• 1 other identifier: MIS5005517
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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 failure.

Conditions

Heart Failure

Keywords

heart failure; exercise; life coach

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Virtual Coach

EXPERIMENTAL

BiotechCoachForAll

Other: BiotechCoachForAll

Interventions

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.

Virtual Coach

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (2)

AHEPA University Hospital of Thessaloniki

Thessaloniki, Greece

Location

Laboratory of Medical Physics, AUTH

Thessaloniki, Greece

Location

Related Publications (4)

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

  PMID: 27207191 BACKGROUND

• Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.

  PMID: 25520374 BACKGROUND

• Cichosz SL, Ehlers LH, Hejlesen O. Health effectiveness and cost-effectiveness of telehealthcare for heart failure: study protocol for a randomized controlled trial. Trials. 2016 Dec 12;17(1):590. doi: 10.1186/s13063-016-1722-5.

  PMID: 27955682 BACKGROUND

• Billis A, Pandria N, Mouratoglou SA, Konstantinidis E, Bamidis P. Development of Cognitive and Physical Exercise Systems, Clinical Recordings, Large-Scale Data Analytics, and Virtual Coaching for Heart Failure Patients: Protocol for the BioTechCOACH-ForALL Project. JMIR Res Protoc. 2020 May 4;9(5):e17714. doi: 10.2196/17714.

  PMID: 32364512 DERIVED

MeSH Terms

Conditions

Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Panagiotis Bamidis, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: March 15, 2019
• Study Start: July 18, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

GR (2)