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Completed

NCT Number: NCT04636970

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

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.

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Key information

Conditions

Frailty Autonomic Nervous System Imbalance Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Kaunas, Kulautuva, Lithuania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Autonomic nervous function by Heart Rate Recovery (HRR)

    Time frame: 3 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.

  2. Autonomic nervous function by Heart Rate Recovery (HRR)

    Time frame: 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.

  3. Autonomic nervous function by Heart Rate Fragmentation (HRR)

    Time frame: 3 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).

  4. Autonomic nervous function by Heart Rate Fragmentation (HRR)

    Time frame: 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).

Secondary outcomes

  1. Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)

    Time frame: 3 weeks

    PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute

  2. Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)

    Time frame: 12 weeks

    PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute

  3. Cardiopulmonary exercise capacity by maximal load (maxWatt)

    Time frame: 3 weeks

    Maximal load measured with spiroergometry by maximal watts

  4. Cardiopulmonary exercise capacity by maximal load (maxWatt)

    Time frame: 12 weeks

    Maximal load measured with spiroergometry by maximal watts

  5. Functional capacity by six minutes walking test (6MWT)

    Time frame: 3 weeks

    6MWT measured by meters

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

    Time frame: 12 weeks

    6MWT measured by meters

  7. Physical performance by Timed up and Go test (TUG)

    Time frame: 3 weeks

    TUG measured by seconds

  8. Physical performance by Timed up and Go test (TUG)

    Time frame: 12 weeks

    TUG measured by seconds

  9. Gait evaluation by step time

    Time frame: 3 weeks

    Step time measured with treadmill ergometer by seconds

  10. Gait evaluation by step time

    Time frame: 12 weeks

    Step time measured with treadmill ergometer by seconds

  11. Frailty level by Edmonton frailty scale (EFS)

    Time frame: 3 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.

  12. Frailty level by Edmonton frailty scale (EFS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Collaborators

  • Kaunas University of Technology

Registry information

Official study 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

Acronym: FrailHeart

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2020
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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