Cardiac Rehabilitation and Frailty Physical Training Program in Elderly Patients After Open Heart Surgery

Vitalija Stonkuvienė

Status: Completed

Conditions: Surgery; Frailty

Treatments: Other: Computer-based interactive training group; Other: Multicomponent training group

Study type: Interventional

Funder types: Other

Identifiers

NCT06385041

BE-2-83

Details and patient eligibility

About

The aim of the research - to evaluate the impact of interactive physical therapy tools for functional capacity, fear of falls, motivation and quality of life after open heart surgery due to ischemic heart disease and frailty in the second stage of rehabilitation.

Full description

The clinical trial will be performed during patient rehabilitation. All examination of the patient will be performed before rehabilitation and at the end of rehabilitation. Total subjects will spend 20 days in rehabilitation. All subjects who will have frailty syndrome will be assigned to one of three groups: control, intervention group-1 or intervention group-2.

Enrollment: 153 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient's agreement to participate in the study,
• Age 65 years and older,
• Patients admitted to cardiac rehabilitation after open heart surgery,
• Patients with frailty (Edmonton frailty scale ≥4)
• 6-minute walk distance (6-MWD) ≥150 meters and walking without mobility aid.

Exclusion criteria

• Patient's disagreement to participate in the study
• Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in cardiac rehabilitation according to study protocol), cognitive, vision, linguistic deficits, chronic heart failure Class IV, anemia, wound healing disturbance or other various acute conditions that may limit active participation in physical therapy programs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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153 participants in 3 patient groups

Control group

No Intervention group

Description:

Physical training program will include: dosed aerobic training program on cycle ergometers (6 days/week, for 10-30 minutes, 30-50% watts or 30-50% HRmax). The training program consists individually according to the person state of health and respiratory muscle training (7 days/week, for 15 minutes).

Multicomponent training group

Experimental group

Description:

Physical training program will include: dosed aerobic training program on cycle ergometers and respiratory muscle trainings as in control group. Also patients will get an individualized exercise program for frailty syndrome, which will include strength exercises (with elastic resistance bands and weights) and balance training (unstable surfaces) 3 times/week 30-45 minutes.

Treatment:

Other: Multicomponent training group

Computer-based interactive training group

Experimental group

Description:

Physical training program will include: dosed aerobic training program on cycle ergometers and respiratory muscle trainings as in control group. Also patients will get an individualized program for frailty syndrome, with the help of interactive technologies 3 times/week. 30-45 minutes (gait training with Biodex GaitTrainerTM3 with visual and audio feedback, Zebris FDM-T, with the help of which virtual barriers are created, thus simulating real environment for the patient, while performing a cognitive task, for balance training investigators used a computerized Biodex board. For strength training investigators used equipment HUR based on pneumatic (air pressure) technology.

Treatment:

Other: Computer-based interactive training group