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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03877328
• Other study ID #: MIS5005517
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2021
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Greece	AHEPA University Hospital of Thessaloniki	Thessaloniki
Greece	Laboratory of Medical Physics, AUTH	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View Citation

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després 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. Erratum in: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417. — View Citation

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, González-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The subjects' functionality assessed both prior intervention and at the end of the study	Functional capacity assessed by WHO functional class	3 months
Primary	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
Primary	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
Primary	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
Primary	Hospitalization	The number of hospital admissions	3 months
Primary	Healthcare usage	The healthcare usage expressed by the relevant medical assistance usage	3 months