Clinical trial NCT06385041: Cardiac Rehabilitation and Frailty Physical Training Program in Elderly Patients After Open Heart Surgery
Official title: Impact of Interactive Physical Therapy 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty Syndrome
Keywords: evaluate the impact of physical therapy tools for functional capacity, fear of falls, motivation, quality of life after open heart surgery and frailty
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patient's agreement to participate in the study,
* Age 65 years and older,
* Patients admitted to CR 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.

Primary outcomes:
measure: Collecting data from the medical history
timeFrame: baseline
measure: Frailty level by Edmonton frail scale score
timeFrame: baseline
measure: Fear of Falling by Falls Efficacy Scale International; FES-I).
timeFrame: baseline, 20 days.
measure: Quality of life by EuroQoL FiveDimensionsEQ-5D-5L.
timeFrame: baseline, 20 days.
measure: Motivation by Multidimensional Health Locus of Control scale
timeFrame: baseline, 20 days.
measure: Change from baseline functional capacity by six minutes walking test (6MWT)
timeFrame: baseline, 20 days.
measure: Change from baseline physical performance by Short Physical Performance Battery (SPPB)
timeFrame: baseline, 20 days.
measure: Change from baseline muscular strength by one repetition maximum test (1RM)
timeFrame: baseline, 20 days.
measure: Change from baseline grip strength by hydraulic hand dinanometer
timeFrame: baseline, 20 days.
measure: Change from baseline balance parameters by Biodex Balance System SD
timeFrame: baseline, 20 days.
measure: Change from baseline stance and gait parameters by Zebris Medical GmbH
timeFrame: baseline, 20 days.
Secondary outcomes:
measure: Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)
timeFrame: baseline, 20 days.
measure: Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
timeFrame: baseline, 20 days.
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
Study officials:
affiliation: LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
name: Raimondas Kubilius, prof, MD
role: PRINCIPAL_INVESTIGATOR
References: