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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: BiotechCoachForAll

• Registration Number: NCT03877328
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Detailed 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.

Study Timeline

• Study Start: 2018-07-18
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-15
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Coach	BiotechCoachForAll	BiotechCoachForAll

Primary Outcome Measures

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

Trial Locations

Locations (2)

Laboratory of Medical Physics, AUTH; 🇬🇷 Thessaloniki, Greece

AHEPA University Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece