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

Frailty Clinical Trial

— FrailHeart  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04636970
• Other study ID #: LUHS002
• Status: Completed
• Phase: N/A
• Start date: November 19, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2022
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Nervous System Imbalance
• Frailty

Intervention

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.

Locations

Country	Name	City	State
Lithuania	LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva	Kaunas	Kulautuva

Sponsors (2)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	Kaunas University of Technology

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Cardiopulmonary exercise capacity by maximal load (maxWatt)	Maximal load measured with spiroergometry by maximal watts	3 weeks
Secondary	Cardiopulmonary exercise capacity by maximal load (maxWatt)	Maximal load measured with spiroergometry by maximal watts	12 weeks
Secondary	Functional capacity by six minutes walking test (6MWT)	6MWT measured by meters	3 weeks
Secondary	Functional capacity by six minutes walking test (6MWT)	6MWT measured by meters	12 weeks
Secondary	Physical performance by Timed up and Go test (TUG)	TUG measured by seconds	3 weeks
Secondary	Physical performance by Timed up and Go test (TUG)	TUG measured by seconds	12 weeks
Secondary	Gait evaluation by step time	Step time measured with treadmill ergometer by seconds	3 weeks
Secondary	Gait evaluation by step time	Step time measured with treadmill ergometer by seconds	12 weeks
Secondary	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
Secondary	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