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

Lithuanian University of Health Sciences

Status: Completed

Conditions: Autonomic Nervous System Imbalance; Frailty

Treatments: Other: Home training program

Study type: Interventional

Funder types: Other

Identifiers

NCT04636970

LUHS002

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Control group

No Intervention group

Description:

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

Intervention group

Experimental group

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.

Treatment:

Other: Home training program