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

NCT04636970 | Completed

• 1 other identifier: LUHS002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Autonomic Nervous System Imbalance

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)

  3 weeks

• Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)

  12 weeks

• Cardiopulmonary exercise capacity by maximal load (maxWatt)

  3 weeks

• Cardiopulmonary exercise capacity by maximal load (maxWatt)

  12 weeks

• Functional capacity by six minutes walking test (6MWT)

  3 weeks

Study Arms (2)

Control group

NO INTERVENTION

Patients randomised to control group will get usual recommendations regarding physical activity after a discharge from inpatient cardiac rehabilitation.

Intervention group

EXPERIMENTAL

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

Interventions

Home training program OTHER

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.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients admitted to CR after open heart surgery.
• Age 65 years and older.
• minute walk distance (6-MWD) ≥150 meters.
• Patient's agreement to participate in the study.
• Edomonton Frailty Scale score 5 points and more

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Kaunas University of Technology: collaborator

Study Sites (1)

LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Kaunas, Kulautuva, Lithuania

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raimondas Kubilius, MD, PhD

  Lithuanian University of Health Sciences, Department of Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of a Rehabilitation department, Lithuanian University of Health Sciences hospital Kaunas Clinics, Kulautuva rehabilitation hospital

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 19, 2020
• Study Start: November 19, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)