Unobtrusive Technologies for Monitoring of Autonomic Nervous System Function in Elderly Frail Patients
- Conditions
- FrailtyAutonomic Nervous System Imbalance
- Interventions
- Other: Home training program
- Registration Number
- NCT04636970
- Lead Sponsor
- Lithuanian University of Health Sciences
- Brief Summary
To develop and investigate an unobtrusive technology for long-term monitoring of autonomic nervous system (ANS) function's response to daily physical stressors and exercise training for elderly patients with different frailty stages.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Patients admitted to CR after open heart surgery.
- Age 65 years and older.
- 6-minute walk distance (6-MWD) ≥150 meters.
- Patient's agreement to participate in the study.
- Edomonton Frailty Scale score 5 points and more
- Cardiac devices (due to artificially altered heart rate series)
- Diseases in the musculoskeletal system or other organs complicating physical activity and exercise training;
- Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in CR according to study protocol), including chronic heart failure New York Heart Association Class IV, hemoglobin less than 9 g/dL, wound healing disturbance, cognitive or linguistic deficits.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Home training program Patients randomised to intervention group will continue home exercise training that will last 12 weeks and consists of endurance, flexibility, balance and cardiovascular resistance training performed with low to moderate intensity, in 20-60 minutes sessions, five times a week. Study participants will be asked to wear wrist and chest unobtrusive devices during active day time or at least during the training session and two hours before and after. Study participants well receive telephone calls every other week and were asked to answer questions regarding their health and physical activity.
- Primary Outcome Measures
Name Time Method Autonomic nervous function by Heart Rate Fragmentation (HRR) 12 weeks HRF measured by RR interval indexes:percentage of inflection points (PIP), inverse of the average length of the acceleration/deceleration segments (IALS), percentage of short segments (PAS), percentage of alternation segments (PSS).
Autonomic nervous function by Heart Rate Recovery (HRR) 12 weeks HRR (beats per minute) is a difference of the maximal HR obtained during stress testing and HR during the recovery period: HR30-360 the decay of heart rate from 30 to 360 s after the recovery onset.
- Secondary Outcome Measures
Name Time Method Functional capacity by six minutes walking test (6MWT) 12 weeks 6MWT measured by meters
Gait evaluation by step time 12 weeks Step time measured with treadmill ergometer by seconds
Frailty level by Edmonton frailty scale (EFS) 12 weeks 0-17 points, the higher the worse. The EFS assesses 9 domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance.
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2) 12 weeks PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Cardiopulmonary exercise capacity by maximal load (maxWatt) 12 weeks Maximal load measured with spiroergometry by maximal watts
Physical performance by Timed up and Go test (TUG) 12 weeks TUG measured by seconds
Trial Locations
- Locations (1)
LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
🇱🇹Kaunas, Kulautuva, Lithuania