Back to resultsUnobtrusive Technologies for Monitoring of Autonomic Nervous System Function in Elderly Frail Patients (FrailHeart)
Primary Purpose
Frailty, Autonomic Nervous System Imbalance
Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Home training program
Sponsored by
About this trial
This is an interventional treatment trial for Frailty focused on measuring Cardiac rehabilitation, Cardiac surgery, Resistance training, Exercise training, Frailty, Elderly
Eligibility Criteria
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.
Sites / Locations
- LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention group
Arm Description
Patients randomised to control group will get usual recommendations regarding physical activity after a discharge from inpatient cardiac rehabilitation.
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.
Outcomes
Primary Outcome Measures
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.
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.
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).
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).
Secondary Outcome Measures
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Maximal load measured with spiroergometry by maximal watts
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Maximal load measured with spiroergometry by maximal watts
Functional capacity by six minutes walking test (6MWT)
6MWT measured by meters
Functional capacity by six minutes walking test (6MWT)
6MWT measured by meters
Physical performance by Timed up and Go test (TUG)
TUG measured by seconds
Physical performance by Timed up and Go test (TUG)
TUG measured by seconds
Gait evaluation by step time
Step time measured with treadmill ergometer by seconds
Gait evaluation by step time
Step time measured with treadmill ergometer by seconds
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.
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.
Full Information
NCT ID
NCT04636970
First Posted
November 9, 2020
Last Updated
August 16, 2022
Sponsor
Lithuanian University of Health Sciences
Collaborators
Kaunas University of Technology
1. Study Identification
Unique Protocol Identification Number
NCT04636970
Brief Title
Unobtrusive Technologies for Monitoring of Autonomic Nervous System Function in Elderly Frail Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences
Collaborators
Kaunas University of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Autonomic Nervous System Imbalance
Keywords
Cardiac rehabilitation, Cardiac surgery, Resistance training, Exercise training, Frailty, Elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients randomised to control group will get usual recommendations regarding physical activity after a discharge from inpatient cardiac rehabilitation.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Home training program
Intervention Description
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 Outcome Measure Information:
Title
Autonomic nervous function by Heart Rate Recovery (HRR)
Description
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.
Time Frame
3 weeks
Title
Autonomic nervous function by Heart Rate Recovery (HRR)
Description
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.
Time Frame
12 weeks
Title
Autonomic nervous function by Heart Rate Fragmentation (HRR)
Description
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).
Time Frame
3 weeks
Title
Autonomic nervous function by Heart Rate Fragmentation (HRR)
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Description
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Time Frame
3 weeks
Title
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Description
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Time Frame
12 weeks
Title
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Description
Maximal load measured with spiroergometry by maximal watts
Time Frame
3 weeks
Title
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Description
Maximal load measured with spiroergometry by maximal watts
Time Frame
12 weeks
Title
Functional capacity by six minutes walking test (6MWT)
Description
6MWT measured by meters
Time Frame
3 weeks
Title
Functional capacity by six minutes walking test (6MWT)
Description
6MWT measured by meters
Time Frame
12 weeks
Title
Physical performance by Timed up and Go test (TUG)
Description
TUG measured by seconds
Time Frame
3 weeks
Title
Physical performance by Timed up and Go test (TUG)
Description
TUG measured by seconds
Time Frame
12 weeks
Title
Gait evaluation by step time
Description
Step time measured with treadmill ergometer by seconds
Time Frame
3 weeks
Title
Gait evaluation by step time
Description
Step time measured with treadmill ergometer by seconds
Time Frame
12 weeks
Title
Frailty level by Edmonton frailty scale (EFS)
Description
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.
Time Frame
3 weeks
Title
Frailty level by Edmonton frailty scale (EFS)
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raimondas Kubilius, MD, PhD
Organizational Affiliation
Lithuanian University of Health Sciences, Department of Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
City
Kaunas
State/Province
Kulautuva
Country
Lithuania
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant anonymous data may be shared upon appropriate request.
Learn more about this trial
Unobtrusive Technologies for Monitoring of Autonomic Nervous System Function in Elderly Frail Patients
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