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临床试验/NCT06385041
NCT06385041已完成不适用

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 Stonkuvienė2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2021年7月22日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
153
试验地点
2
主要终点
Collecting data from the medical history

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Collecting data from the medical history

时间窗: baseline

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

Frailty level by Edmonton frail scale score

时间窗: 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).

时间窗: 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.

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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 balance parameters by Biodex Balance System SD

时间窗: 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

时间窗: 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.

Collecting data from the medical history

时间窗: baseline

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

Frailty level by Edmonton frail scale score

时间窗: 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).

时间窗: 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.

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: baseline, 20 days.

Grip muscle strength will be measured by kilograms.

Change from baseline balance parameters by Biodex Balance System SD

时间窗: 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

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Vitalija Stonkuvienė
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Vitalija Stonkuvienė

Principal Investigator

Lithuanian University of Health Sciences

研究点 (2)

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