FrailtyFrailHeartNCT04636970
Unobtrusive Technologies for Monitoring of Autonomic Nervous System Function in Elderly Frail Patients
A study testing Home training program in people with Frailty and Autonomic Nervous System Imbalance, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Autonomic Nervous System Imbalance
- What is being tested?
- Home training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- 19 Nov 2020to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
Kaunas, Kulautuva
About this study
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
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
- Being tested
- Home training program
- Keywords
- Cardiac rehabilitation, Cardiac surgery, Resistance training, Exercise training, Frailty, Elderly
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Home training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 12 weeks
Secondary outcomes (12)
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Measured: 3 weeks
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Measured: 12 weeks
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Maximal load measured with spiroergometry by maximal watts
Measured: 3 weeks
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Maximal load measured with spiroergometry by maximal watts
Measured: 12 weeks
Functional capacity by six minutes walking test (6MWT)
6MWT measured by meters
Measured: 3 weeks
Functional capacity by six minutes walking test (6MWT)
6MWT measured by meters
Measured: 12 weeks
Physical performance by Timed up and Go test (TUG)
TUG measured by seconds
Measured: 3 weeks
Physical performance by Timed up and Go test (TUG)
TUG measured by seconds
Measured: 12 weeks
Gait evaluation by step time
Step time measured with treadmill ergometer by seconds
Measured: 3 weeks
Gait evaluation by step time
Step time measured with treadmill ergometer by seconds
Measured: 12 weeks
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.
Measured: 3 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start19 Nov 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Kaunas University of Technology
- Responsible party
- Principal investigator, Eglė Tamulevičiūtė-Prascienė, Lithuanian University of Health Sciences
- Investigators
- Raimondas Kubilius, MD, PhD, Principal investigator, Lithuanian University of Health Sciences, Department of Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636970
- Sponsor's protocol ID
- LUHS002
- Acronym
- FrailHeart
- Status last verified
- Aug 2022
- First submitted
- 9 Nov 2020
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant anonymous data may be shared upon appropriate request.
Publications
Tamuleviciute-Prasciene E, Balne K, Kuznecova I, Beigiene A, Stonkuviene V, Kubilius R. Frailty and functional recovery after cardiac surgery: a randomized pilot trial of extended exercise-based rehabilitation. BMC Geriatr. 2026 Feb 24;26(1):433. doi: 10.1186/s12877-026-07192-5.
PubMed 41731374
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04636970
- Acronym / sponsor ID
- FrailHeart / LUHS002
- Conditions
- Frailty, Autonomic Nervous System Imbalance
- Keywords
- Cardiac rehabilitation, Cardiac surgery, Resistance training, Exercise training, Frailty, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Kaunas University of Technology
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Home training programPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home training programSubjects 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. | Other | Intervention group |
Primary outcome
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.
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.
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).
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).
12 secondary outcomes
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Time frame: 3 weeks
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Time frame: 12 weeks
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Time frame: 3 weeks
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Time frame: 12 weeks
Functional capacity by six minutes walking test (6MWT)
Time frame: 3 weeks
Functional capacity by six minutes walking test (6MWT)
Time frame: 12 weeks
Physical performance by Timed up and Go test (TUG)
Time frame: 3 weeks
Physical performance by Timed up and Go test (TUG)
Time frame: 12 weeks
Gait evaluation by step time
Time frame: 3 weeks
Gait evaluation by step time
Time frame: 12 weeks
Frailty level by Edmonton frailty scale (EFS)
Time frame: 3 weeks
Frailty level by Edmonton frailty scale (EFS)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 41731374Tamuleviciute-Prasciene E, Balne K, Kuznecova I, Beigiene A, Stonkuviene V, Kubilius R. Frailty and functional recovery after cardiac surgery: a randomized pilot trial of extended exercise-based rehabilitation. BMC Geriatr. 2026 Feb 24;26(1):433. doi: 10.1186/s12877-026-07192-5.
- Individual participant dataSharing planned: No. Individual participant anonymous data may be shared upon appropriate request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raimondas Kubilius, MD, PhD principal investigator
Lithuanian University of Health Sciences, Department of Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home training program in people with Frailty and Autonomic Nervous System Imbalance, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic nervous function by Heart Rate Recovery (HRR) (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04636970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.