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Clinical Trials/NCT06385041
NCT06385041
Completed
Not Applicable

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.

Vitalija Stonkuvienė1 site in 1 country153 target enrollmentJuly 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Vitalija Stonkuvienė
Enrollment
153
Locations
1
Primary Endpoint
Collecting data from the medical history
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 22, 2021
End Date
May 22, 2024
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Vitalija Stonkuvienė
Responsible Party
Sponsor Investigator
Principal Investigator

Vitalija Stonkuvienė

Principal Investigator

Lithuanian University of Health Sciences

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.

Outcomes

Primary Outcomes

Collecting data from the medical history

Time Frame: baseline

comorbidities, date of surgery, etc. only with the subject's agreement

Frailty level by Edmonton frail scale score

Time Frame: baseline

The Edmonton frail scale assesses 9 domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance. Frailty level is measured by the Edmonton frail scale score - 0-3 - fit, 4-5 - vulnerable, 6-7 - mild frailty, 8-9 - moderate frailty,10-17 - severe frailty.

Fear of Falling by Falls Efficacy Scale International; FES-I).

Time Frame: baseline, 20 days.

The FES-1 was used to assess the fear of falling level of participants about falling during indoor or outdoor activities. It has 16 items scored on a four-point Likert scale. assess the fear of falling level of participants about falling during indoor or outdoor activities minimum score 16 maximum score 64. The level of concern for each item is scored on a 4-point scale (1: not at all, 2: somewhat, 3: quite a lot, 4: very), with the total score range being 16 to 64.The results are divided into 3 parts: low 16-19, moderate 20-27, and high concern 28-64 points.

Quality of life by EuroQoL FiveDimensionsEQ-5D-5L.

Time Frame: baseline, 20 days.

The EQ-5D-5L consists of 2 parts: descriptive system and visual analogue scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS (visual analogue scale) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

Motivation by Multidimensional Health Locus of Control scale

Time Frame: baseline, 20 days.

It is one of the most commonly-used parameters of health belief in planning the health education programs. The health locus of control is the degree to which individual believe that his or her behavior is controlled by external or internal factors. The survey contains with 18 items and consist of three subscales, namely Internal Health Locus of Control, Powerful Others Health Locus of Control, and Chance Health Locus of Control. Each of these subscales contains six items with a six-point Likert response scale ranging from 'Strongly Agree' to 'Strongly Disagree'. Scores for each subscale reflect the total score for the corresponding 6 items, with subscales having a minimum score of 6 and maximum score of 36.

Change from baseline functional capacity by six minutes walking test (6MWT)

Time Frame: baseline, 20 days.

6MWT measured by meters. This test is performed preferably indoors, on a flat, straight,hard-surfaced corridor usually at least 30m long. The patient is told to be wear comfortable clothing and shoes. The physical therapist records heart rate and brachial arterial blood pressure and the Borg scale rating for dyspnea and fatigue before and after the test.

Change from baseline physical performance by Short Physical Performance Battery (SPPB)

Time Frame: baseline, 20 days.

The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests.The scores range from 0 (worst performance) to 12 (best performance).

Change from baseline muscular strength by one repetition maximum test (1RM)

Time Frame: baseline, 20 days.

1RM test for leg press is measured by kilograms. The one-repetition maximum (1RM) test is often considered as the 'gold standard' for assessing the strength capacity of individuals. It is simply defined as the maximal weight an individual can lift for only one repetition with correct technique.The 1RM machine leg press is often used as a measure of maximal lower body strength with older subjects.

Change from baseline grip strength by hydraulic hand dynamometer

Time Frame: baseline, 20 days.

Grip muscle strength will be measured by kilograms.

Change from baseline balance parameters by Biodex Balance System SD

Time Frame: baseline, 20 days.

Using Biodex Balance system with stable and unstable surface with open and closed eyes balance tests are performed (Limits of Stability, Fall Risk, Modified Clinical Test of Sensory Integration and Balance, Balance Error Scoring System).

Change from baseline stance and gait parameters by Zebris Medical GmbH

Time Frame: baseline, 20 days.

Using Zebris medical GmbH platform stance and gait parameters are measured. It includes average forces for left and right foot, max load of body weight, foot rotation degree, Step length,Stride length,Step width,Stance, Swing and Double stance phases parameters, Step time,Stride time,Cadence,Velocity,Length of gait line,Single limb support line,Ant/post position,Lateral symmetry,Max gait line velocity,Force parameters, Load change, Maximum force, Maximum pressure,Time maximum force,Contact time.

Secondary Outcomes

  • Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)(baseline, 20 days.)
  • Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)(baseline, 20 days.)

Study Sites (1)

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