Unobtrusive Technologies for Monitoring of Autonomic Nervous System Function in Elderly Frail Patients

Study Overview
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Brief Summary
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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.

Official Title
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Unobtrusive Technologies for Monitoring of Autonomic Nervous System Function in a Setting of Inpatient Cardiac Rehabilitation and Home Training Program in Elderly Patients With Different Frailty Stages

Conditions
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Frailty, Autonomic Nervous System Imbalance

Intervention / Treatment
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* Other: Home training program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Patients randomised to control group will get usual recommendations regarding physical activity after a discharge from inpatient cardiac rehabilitation. | |
| Experimental: Intervention group<br>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. | Other: Home training program<br>* Subjects randomized to the IG will participate at home training program 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic nervous function by Heart Rate Recovery (HRR) | 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. | 3 weeks | 
| Autonomic nervous function by Heart Rate Recovery (HRR) | 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. | 12 weeks | 
| Autonomic nervous function by Heart Rate Fragmentation (HRR) | 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). | 3 weeks | 
| Autonomic nervous function by Heart Rate Fragmentation (HRR) | 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). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2) | PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute | 3 weeks | 
| Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2) | PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute | 12 weeks | 
| Cardiopulmonary exercise capacity by maximal load (maxWatt) | Maximal load measured with spiroergometry by maximal watts | 3 weeks | 
| Cardiopulmonary exercise capacity by maximal load (maxWatt) | Maximal load measured with spiroergometry by maximal watts | 12 weeks | 
| Functional capacity by six minutes walking test (6MWT) | 6MWT measured by meters | 3 weeks | 
| Functional capacity by six minutes walking test (6MWT) | 6MWT measured by meters | 12 weeks | 
| Physical performance by Timed up and Go test (TUG) | TUG measured by seconds | 3 weeks | 
| Physical performance by Timed up and Go test (TUG) | TUG measured by seconds | 12 weeks | 
| Gait evaluation by step time | Step time measured with treadmill ergometer by seconds | 3 weeks | 
| Gait evaluation by step time | Step time measured with treadmill ergometer by seconds | 12 weeks | 
| Frailty level by Edmonton frailty scale (EFS) | 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. | 3 weeks | 
| Frailty level by Edmonton frailty scale (EFS) | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac rehabilitation, Cardiac surgery, Resistance training, Exercise training, Frailty, Elderly