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

NCT ID: NCT06385041

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-22
• Study Completion Date: 2024-05-22

Brief Summary

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.

Detailed 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.

Conditions

Frailty; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Multicomponent training group

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.

Group Type: EXPERIMENTAL

Multicomponent training group

Intervention Type: OTHER

Additional exercise program with balance and strength trainings will include 3 times/week. Patients will get an individualized exercise program for frailty syndrome, which will include strength exercises (with elastic resistance bands and weights up to 2kg 30-50% 1RM) and balance training (with unstable surfaces). The program will be performed by 3 sets with 10 repetitions 3 times/week 30-45 minutes.

Computer-based interactive training group

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.

Group Type: EXPERIMENTAL

Computer-based interactive training group

Intervention Type: OTHER

Additional exercise program with balance and strength trainings will include 3 times/week 30-45 minutes. Patients will get an individualized program for frailty syndrome, with interactive technologies: gait training with Biodex GaitTrainerTM3 with visual, audio feedback and incline up to 10-15 min, Zebris FDM-T, with virtual barriers, thus simulating real environment for the patient, while performing a cognitive task up to 10-15 min, for balance training investigators used a computerized Biodex board. Exercises will be performed with the programs: Postural stability training, Limits of stability training, Weight shift training, Maze control training, Random control training, Percent weight-bearing training. For strength training investigators used equipment HUR based on pneumatic (air pressure) technology. For strength training intensity 30-50% 1-RM, 10 repetitions with 3 sets. Leg press, leg extension, leg abduction, leg adduction will be performed with pneumatic technology.

Interventions

Multicomponent training group

Additional exercise program with balance and strength trainings will include 3 times/week. Patients will get an individualized exercise program for frailty syndrome, which will include strength exercises (with elastic resistance bands and weights up to 2kg 30-50% 1RM) and balance training (with unstable surfaces). The program will be performed by 3 sets with 10 repetitions 3 times/week 30-45 minutes.

Intervention Type: OTHER

Computer-based interactive training group

Additional exercise program with balance and strength trainings will include 3 times/week 30-45 minutes. Patients will get an individualized program for frailty syndrome, with interactive technologies: gait training with Biodex GaitTrainerTM3 with visual, audio feedback and incline up to 10-15 min, Zebris FDM-T, with virtual barriers, thus simulating real environment for the patient, while performing a cognitive task up to 10-15 min, for balance training investigators used a computerized Biodex board. Exercises will be performed with the programs: Postural stability training, Limits of stability training, Weight shift training, Maze control training, Random control training, Percent weight-bearing training. For strength training investigators used equipment HUR based on pneumatic (air pressure) technology. For strength training intensity 30-50% 1-RM, 10 repetitions with 3 sets. Leg press, leg extension, leg abduction, leg adduction will be performed with pneumatic technology.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vitalija Stonkuvienė

OTHER

Sponsor Role: lead

Responsible Party

Vitalija Stonkuvienė

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Raimondas Kubilius, prof, MD

Role: PRINCIPAL_INVESTIGATOR

LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Locations

LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

BE-2-83

Identifier Type: -

Identifier Source: org_study_id