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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-19

Study Completion Date

2022-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Frailty Autonomic Nervous System Imbalance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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.

Group Type EXPERIMENTAL

Home training program

Intervention Type 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.

Interventions

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Home 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No