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

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

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.

Study Overview

• Status: Completed
• Conditions: Frailty; Autonomic Nervous System Imbalance
• Intervention / Treatment: Other: Home training program

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Kulautuva
    • Kaunas, Kulautuva, Lithuania
      • LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients randomised to control group will get usual recommendations regarding physical activity after a discharge from inpatient cardiac rehabilitation.
Experimental: Intervention group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Collaborators: Kaunas University of Technology
• Investigators: Principal Investigator: Raimondas Kubilius, MD, PhD, Lithuanian University of Health Sciences, Department of Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Elderly; Cardiac rehabilitation; Exercise training; Frailty; Cardiac surgery; Resistance training
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: LUHS002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant anonymous data may be shared upon appropriate request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No