Clinical trial NCT04636970: Unobtrusive Technologies for Monitoring of Autonomic Nervous System Function in Elderly Frail Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Autonomic Nervous System Imbalance
Keywords: Cardiac rehabilitation
Cardiac surgery
Resistance training
Exercise training
Frailty
Elderly
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Kaunas University of Technology
First posted: 2020-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Autonomic nervous function by Heart Rate Recovery (HRR)
timeFrame: 3 weeks
measure: Autonomic nervous function by Heart Rate Recovery (HRR)
timeFrame: 12 weeks
measure: Autonomic nervous function by Heart Rate Fragmentation (HRR)
timeFrame: 3 weeks
measure: Autonomic nervous function by Heart Rate Fragmentation (HRR)
timeFrame: 12 weeks
Secondary outcomes:
measure: Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
timeFrame: 3 weeks
measure: Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
timeFrame: 12 weeks
measure: Cardiopulmonary exercise capacity by maximal load (maxWatt)
timeFrame: 3 weeks
measure: Cardiopulmonary exercise capacity by maximal load (maxWatt)
timeFrame: 12 weeks
measure: Functional capacity by six minutes walking test (6MWT)
timeFrame: 3 weeks
measure: Functional capacity by six minutes walking test (6MWT)
timeFrame: 12 weeks
measure: Physical performance by Timed up and Go test (TUG)
timeFrame: 3 weeks
measure: Physical performance by Timed up and Go test (TUG)
timeFrame: 12 weeks
measure: Gait evaluation by step time
timeFrame: 3 weeks
measure: Gait evaluation by step time
timeFrame: 12 weeks
measure: Frailty level by Edmonton frailty scale (EFS)
timeFrame: 3 weeks
measure: Frailty level by Edmonton frailty scale (EFS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
state: Kulautuva
Study officials:
affiliation: Lithuanian University of Health Sciences, Department of Rehabilitation
name: Raimondas Kubilius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: