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

Not Applicable

Completed

• Conditions: Frailty; Autonomic Nervous System Imbalance

• 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

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-18
• Study Start: 2020-11-19
• Study First Posted: 2020-11-19
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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
Functional capacity by six minutes walking test (6MWT)	12 weeks	6MWT measured by meters
Physical performance by Timed up and Go test (TUG)	12 weeks	TUG measured by seconds
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.

Trial Locations

Locations (1)

LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva; 🇱🇹 Kaunas, Kulautuva, Lithuania