BioTechCOACH-ForALL: Development of Mental and Physical Exercise Systems, Clinical Recording, Supervisory Analytical Large-scale Data and Virtual Guidance of Vulnerable Population Groups
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- The subjects' exercise intolerance assessed both prior intervention and at the end of the study
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
Hospitalization
Time Frame: 3 months
The number of hospital admissions
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
Healthcare usage
Time Frame: 3 months
The healthcare usage expressed by the relevant medical assistance usage
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Panos Bamidis
Associate Professor
Aristotle University Of Thessaloniki