The Effect of Exercise Training Intervention and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cardiac Autonomic Nervous System Function
研究概览
简要总结
Chronic Heart Failure (CHF) is the endpoint for some cardiac and respiratory conditions as well as ageing affecting 1-2% of the global adult population. CHF requires a costly treatment, frequent hospitalizations due its severe complications leading CHF eventually to a frequent cause of morbidity and mortality worldwide. Another common complication of CHF is frailty. Frailty is a complex clinical syndrome associated with CHF, resulting from multiple organ impairment; physiological reserves decrease and vulnerability to stressors increase. Up to 79% of PwCHF are frail leading to reduced functional capacity, quality of life (QoL), and psychological well-being in CHF, and it is an independent predictor of mortality in cardiovascular disease.
The role of cardiac rehabilitation (CR) programs for PwCHF in preventing frailty has recently draw the attention of the scientific world. Exercise constitutes a unique effective and feasible non-pharmacological treatment for frailty in CHF as it offers such benefits that are irreplaceable by medical treatment, with no side effects, and cost-effective treatment. However, there are no studies examining the effect of training and detraining on muscle strength and balance, fall prevention and fear of falling in PwCHF.
The aim of this randomized controlled trial is to examine whether a 6-month combined aerobic, strengthening and flexibility-mobility CR program and a 3-month de-training period will affect frailty and fall risk in PwCHF. One hundred participants will be randomly allocated into two groups: Group A (Exercise Group) will receive 3 sessions per week for 6 months and Group B(Control Group) will continue their usual physical activity, without participating in organized exercise programs.After the intervention for Group A' will follow a 3- month de-training period and Group B' will continue their normal physical activity. Prior to the group random allocation, part of our assessments at baseline and after 6 (Evaluation A') and 10 months (Evaluation B'), will include demographics and clinical history, physical examination, ECG and echocardiogram, patients' ability to perform daily activities, functional tests, static balance tests, body composition analysis and 24-h heart rhythm holter monitoring. Moreover, we will use questionnaires assessing the QoL of people with CHF, depression, anxiety, sleep quality, cognitive function, fear of falling, physical activity, and sedentary behaviour.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 yrs. of either gender
- •Confirmed diagnosis (by echocardiography) of HF reduced or preserved left ventricular ejection fraction (HFrEF/ΗFpEF)
- •Symptomatic New York Heart Association (NYHA) class II-III
排除标准
- •Acute Myocardial Infarction (<4 weeks)
- •Severe valvular diseases
- •Potentially malignant arrhythmias
- •Νeurological, or orthopedic limitations/non- ambulant status
- •Cognitive disorders
- •Poor regulation of comorbidities
- •Already participating in organized exercise programs
- •Current pregnancy
- •NYHA function class IV
- •Inability/unwillingness to give informed consent
结局指标
主要结局
Cardiac Autonomic Nervous System Function
时间窗: Evaluation B', 3 months
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Six- Minute Walking Test
时间窗: Evaluation B', 3 months after evaluation A'
Estimation of aerobic capacity through six minutes walking test
I-PAQ
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of Physical Activity using I-PAQ
Left Ventricular Systolic Function
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of Left Ventricular Ejection Fraction
Cardiac Autonomic Nervous System Function
时间窗: Evaluation B', 3 months
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Body Composition Analysis
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of Body Composition Analysis
Six- Minute Walking Test
时间窗: Evaluation B', 3 months after evaluation A'
Estimation of aerobic capacity through six minutes walking test
30-second Sit-to-Stand (STS)Test
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of functional capacity and mobility using 30-second STS
Timed- Up-and-Go Test
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of functional capacity and mobility using Timed- Up-and-Go Test
Handgrip Strength
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of Handgrip Strength
30- second Arm Curl Test
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation using Arm Curl Test
SF-36
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of Quality of Life using SF-36
4m-Walking Test
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of functional capacity and mobility using 4m-Walking Test
Static Balance Test using 3D Balance Force Plate
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of Static Balance Test using 3D Balance Force Plate
Strength of Upper and Lower Extremities
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of Strength of Upper and Lower Extremities
Isometric Pulling in a Semi-Squat Position
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of Isometric Pulling in a Semi-Squat Position
I-PAQ
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of Physical Activity using I-PAQ
5 Sit-to-Stand (5-STS)Test
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
Berg Balance Scale Test
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of balance using Berg Balance Scale Test
Functional Gait Assessment Test
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of Functional Gait using Functional Gait Assessement Test
Sit-and-Reach Test
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of mobility-flexibility using Sit-and-Reach Test
Back Scratch Test
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of mobility using Back Scratch Test
mini-BEST Balance Test
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of balance using mini-BEST Balance Test
Beck Depression Inventory
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of Depression using Beck Depression Inventory
Falls Efficacy Scale (FES-I)
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of fear of falling using Falls Efficacy Scale
Activities-specific Balance Confidence (ABC) Scale
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of Balance Confidence using ABC
Minnesota Living with Heart Failure (MLHFQ)
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of health-related quality of life using MLHFQ
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of Sleep Quality using PSQI
Intrinsic Motivation Inventory (IMI)
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of Intrinsic Motivation using IMI
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of Depression and Anxiety using HRSD and HARS
Montreal Cognitive Assessment Test (MOCA)
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of cognitive function using MOCA
Falls
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of the number of weekly falls
Evaluation of Physical Activity and Sleep Quality using a wearable device
时间窗: Evaluation B', 3 months after evaluation A'
Evaluation of Physical Activity and Sleep Quality using a wearable device
Foot Preference Questionnaire (FPQ)
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of Foot Preference during static balance or activities using FPQ
Fear of Falling and Activity Restriction (SAFE)
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of Fear of Falling and Activity Restriction (SAFE)
Trail Making Test
时间窗: Evaluation B', 3 months after evaluation A'
Assessment of visual attention and task switching using Trail Making Test
次要结局
未报告次要终点
研究者
Evangelia Kouidi
Professor of Sports Medicine
Aristotle University Of Thessaloniki