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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04636970
Acronym
FrailHeart
Enrollment
100
Registered
2020-11-19
Start date
2020-11-19
Completion date
2022-04-30
Last updated
2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Nervous System Imbalance, Frailty

Keywords

Cardiac rehabilitation, Cardiac surgery, Resistance training, Exercise training, Frailty, Elderly

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.

Interventions

OTHERHome 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.

Sponsors

Kaunas University of Technology
CollaboratorOTHER
Lithuanian University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Autonomic nervous function by Heart Rate Recovery (HRR)3 weeksHRR (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.
Autonomic nervous function by Heart Rate Fragmentation (HRR)3 weeksHRF 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).

Secondary

MeasureTime frameDescription
Functional capacity by six minutes walking test (6MWT)3 weeks6MWT measured by meters
Physical performance by Timed up and Go test (TUG)3 weeksTUG measured by seconds
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)3 weeksPeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Frailty level by Edmonton frailty scale (EFS)3 weeks0-17 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.
Gait evaluation by step time3 weeksStep time measured with treadmill ergometer by seconds
Cardiopulmonary exercise capacity by maximal load (maxWatt)3 weeksMaximal load measured with spiroergometry by maximal watts

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026