The Effect of Exercise Training and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure

Study Overview
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Brief Summary
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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 4-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 4- 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.

Official Title
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The Effect of Exercise Training Intervention and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure.

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Other: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Exercise Group, 6- month combined aerobic, strengthening, mobility- flexibility exercise intervention, 4- month de-training period | Other: Exercise Intervention<br>* Patients that will be randomly assigned to this group will be invited to attend up to 72 exercise sessions (3 sessions per week) for 24 weeks (6 months) following a combined aerobic, strengthening and mobility-flexibility exercise program. After the exercise intervention, the will follow a 4-month de-training period, continuing their normal physical activity.<br>|
| No Intervention: Group B<br>Control Group, 10- month normal physical activity, without participating in organized sports activities, no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Systolic Function | Evaluation of Left Ventricular Ejection Fraction | Baseline | 
| Left Ventricular Systolic Function | Evaluation of Left Ventricular Ejection Fraction | Evaluation A', 6- months | 
| Left Ventricular Systolic Function | Evaluation of Left Ventricular Ejection Fraction | Evaluation B', 4 months after evaluation A' | 
| Cardiac Autonomic Nervous System Function | Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement | Baseline | 
| Cardiac Autonomic Nervous System Function | Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement | Evaluation A', 6- months | 
| Cardiac Autonomic Nervous System Function | Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement | Evaluation B', 4 months | 
| Body Composition Analysis | Evaluation of Body Composition Analysis | Baseline | 
| Body Composition Analysis | Evaluation of Body Composition Analysis | Evaluation A', 6- months | 
| Body Composition Analysis | Evaluation of Body Composition Analysis | Evaluation B', 4 months after evaluation A' | 
| Six- Minute Walking Test | Estimation of aerobic capacity through six minutes walking test | Baseline | 
| Six- Minute Walking Test | Estimation of aerobic capacity through six minutes walking test | Evaluation A', 6- months | 
| Six- Minute Walking Test | Estimation of aerobic capacity through six minutes walking test | Evaluation B', 4 months after evaluation A' | 
| Timed- Up-and-Go Test | Evaluation of functional capacity using Timed- Up-and-Go Test | Baseline | 
| Timed- Up-and-Go Test | Evaluation of functional capacity using Timed- Up-and-Go Test | Evaluation A', 6- months | 
| Timed- Up-and-Go Test | Evaluation of functional capacity and mobility using Timed- Up-and-Go Test | Evaluation B', 4 months after evaluation A' | 
| 4m-Walking Test | Evaluation of functional capacity and mobility using 4m-Walking Test | Baseline | 
| 4m-Walking Test | Evaluation of functional capacity and mobility using 4m-Walking Test | Evaluation A', 6- months | 
| 4m-Walking Test | Evaluation of functional capacity and mobility using 4m-Walking Test | Evaluation B', 4 months after evaluation A' | 
| 30-second Sit-to-Stand (STS)Test | Evaluation of functional capacity and mobility using 30-second STS | Baseline | 
| 30-second Sit-to-Stand (STS)Test | Evaluation of functional capacity and mobility using 30-second STS | Evaluation A', 6- months | 
| 30-second Sit-to-Stand (STS)Test | Evaluation of functional capacity and mobility using 30-second STS | Evaluation B', 4 months after evaluation A' | 
| 5 Sit-to-Stand (5-STS)Test | Evaluation of functional capacity and mobility using 5 Sit-to-Stand | Baseline | 
| 5 Sit-to-Stand (5-STS)Test | Evaluation of functional capacity and mobility using 5 Sit-to-Stand | Evaluation A', 6- months | 
| 5 Sit-to-Stand (5-STS)Test | Evaluation of functional capacity and mobility using 5 Sit-to-Stand | Evaluation B', 4 months after evaluation A' | 
| mini-BEST Balance Test | Evaluation of balance using mini-BEST Balance Test | Baseline | 
| mini-BEST Balance Test | Evaluation of balance using mini-BEST Balance Test | Evaluation A', 6- months | 
| mini-BEST Balance Test | Evaluation of balance using mini-BEST Balance Test | Evaluation B', 4 months after evaluation A' | 
| Berg Balance Scale Test | Evaluation of balance using Berg Balance Scale Test | Baseline | 
| Berg Balance Scale Test | Evaluation of balance using Berg Balance Scale Test | Evaluation A', 6- months | 
| Berg Balance Scale Test | Evaluation of balance using Berg Balance Scale Test | Evaluation B', 4 months after evaluation A' | 
| Functional Gait Assessment Test | Evaluation of Functional Gait using Functional Gait Assessement Test | Baseline | 
| Functional Gait Assessment Test | Evaluation of Functional Gait using Functional Gait Assessement Test | Evaluation A', 6- months | 
| Functional Gait Assessment Test | Evaluation of Functional Gait using Functional Gait Assessement Test | Evaluation B', 4 months after evaluation A' | 
| Static Balance Test using 3D Balance Force Plate | Evaluation of Static Balance Test using 3D Balance Force Plate | Baseline | 
| Static Balance Test using 3D Balance Force Plate | Evaluation of Static Balance Test using 3D Balance Force Plate | Evaluation A', 6- months | 
| Static Balance Test using 3D Balance Force Plate | Evaluation of Static Balance Test using 3D Balance Force Plate | Evaluation B', 4 months after evaluation A' | 
| Handgrip Strength | Evaluation of Handgrip Strength | Baseline | 
| Handgrip Strength | Evaluation of Handgrip Strength | Evaluation A', 6- months | 
| Handgrip Strength | Evaluation of Handgrip Strength | Evaluation B', 4 months after evaluation A' | 
| Strength of Upper and Lower Extremities | Evaluation of Strength of Upper and Lower Extremities | Baseline | 
| Strength of Upper and Lower Extremities | Evaluation of Strength of Upper and Lower Extremities | Evaluation A', 6- months | 
| Strength of Upper and Lower Extremities | Evaluation of Strength of Upper and Lower Extremities | Evaluation B', 4 months after evaluation A' | 
| Isometric Pulling in a Semi-Squat Position | Evaluation of Isometric Pulling in a Semi-Squat Position | Baseline | 
| Isometric Pulling in a Semi-Squat Position | Evaluation of Isometric Pulling in a Semi-Squat Position | Evaluation A', 6- months | 
| Isometric Pulling in a Semi-Squat Position | Evaluation of Isometric Pulling in a Semi-Squat Position | Evaluation B', 4 months after evaluation A' | 
| 30- second Arm Curl Test | Evaluation using Arm Curl Test | Baseline | 
| 30- second Arm Curl Test | Evaluation using Arm Curl Test | Evaluation A', 6- months | 
| 30- second Arm Curl Test | Evaluation using Arm Curl Test | Evaluation B', 4 months after evaluation A' | 
| Sit-and-Reach Test | Evaluation of mobility-flexibility using Sit-and-Reach Test | Baseline | 
| Sit-and-Reach Test | Evaluation of mobility-flexibility using Sit-and-Reach Test | Evaluation A', 6- months | 
| Sit-and-Reach Test | Evaluation of mobility-flexibility using Sit-and-Reach Test | Evaluation B', 4 months after evaluation A' | 
| Back Scratch Test | Evaluation of mobility using Back Scratch Test | Baseline | 
| Back Scratch Test | Evaluation of mobility using Back Scratch Test | Evaluation A', 6- months | 
| Back Scratch Test | Evaluation of mobility using Back Scratch Test | Evaluation B', 4 months after evaluation A' | 
| SF-36 | Assessement of Quality of Life using SF-36 | Baseline | 
| SF-36 | Assessement of Quality of Life using SF-36 | Evaluation A', 6- months | 
| SF-36 | Assessement of Quality of Life using SF-36 | Evaluation B', 4 months after evaluation A' | 
| I-PAQ | Assessement of Physical Activity using I-PAQ | Baseline | 
| I-PAQ | Assessement of Physical Activity using I-PAQ | Evaluation A', 6- months | 
| I-PAQ | Assessement of Physical Activity using I-PAQ | Evaluation B', 4 months after evaluation A' | 
| Beck Depression Inventory | Assessement of Depression using Beck Depression Inventory | Baseline | 
| Beck Depression Inventory | Assessement of Depression using Beck Depression Inventory | Evaluation A', 6- months | 
| Beck Depression Inventory | Assessement of Depression using Beck Depression Inventory | Evaluation B', 4 months after evaluation A' | 
| Falls Efficacy Scale (FES-I) | Assessement of fear of falling using Falls Efficacy Scale | Baseline | 
| Falls Efficacy Scale (FES-I) | Evaluation of fear of falling using Falls Efficacy Scale | Evaluation A', 6- months | 
| Falls Efficacy Scale (FES-I) | Assessement of fear of falling using Falls Efficacy Scale | Evaluation B', 4 months after evaluation A' | 
| Activities-specific Balance Confidence (ABC) Scale | Assessement of Balance Confidence using ABC | Baseline | 
| Activities-specific Balance Confidence (ABC) Scale | Assessement of Balance Confidence using ABC | Evaluation A', 6- months | 
| Activities-specific Balance Confidence (ABC) Scale | Assessement of Balance Confidence using ABC | Evaluation B', 4 months after evaluation A' | 
| Minnesota Living with Heart Failure (MLHFQ) | Assessement of health-related quality of life using MLHFQ | Baseline | 
| Minnesota Living with Heart Failure (MLHFQ) | Assessement of health-related quality of life using MLHFQ | Evaluation A', 6- months | 
| Minnesota Living with Heart Failure (MLHFQ) | Assessement of health-related quality of life using MLHFQ | Evaluation B', 4 months after evaluation A' | 
| Pittsburgh Sleep Quality Index (PSQI) | Assessement of Sleep Quality using PSQI | Baseline | 
| Pittsburgh Sleep Quality Index (PSQI) | Assessement of Sleep Quality using PSQI | Evaluation A', 6- months | 
| Pittsburgh Sleep Quality Index (PSQI) | Assessement of Sleep Quality using PSQI | Evaluation B', 4 months after evaluation A' | 
| Intrinsic Motivation Inventory (IMI) | Assessement of Intrinsic Motivation using IMI | Baseline | 
| Intrinsic Motivation Inventory (IMI) | Assessement of Intrinsic Motivation using IMI | Evaluation A', 6- months | 
| Intrinsic Motivation Inventory (IMI) | Assessement of Intrinsic Motivation using IMI | Evaluation B', 4 months after evaluation A' | 
| Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS) | Assessement of Depression and Anxiety using HRSD and HARS | Baseline | 
| Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS) | Assessement of Depression and Anxiety using HRSD and HARS | Evaluation A', 6- months | 
| Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS) | Assessement of Depression and Anxiety using HRSD and HARS | Evaluation B', 4 months after evaluation A' | 
| Montreal Cognitive Assessment Test (MOCA) | Assessement of cognitive function using MOCA | Baseline | 
| Montreal Cognitive Assessment Test (MOCA) | Assessement of cognitive function using MOCA | Evaluation A', 6- months | 
| Montreal Cognitive Assessment Test (MOCA) | Assessement of cognitive function using MOCA | Evaluation B', 4 months after evaluation A' | 
| Falls | Assessement of the number of weekly falls | Baseline | 
| Falls | Assessement of the number of weekly falls | Evaluation A', 6- months | 
| Falls | Assessement of the number of weekly falls | Evaluation B', 4 months after evaluation A' | 
| Evaluation of Physical Activity and Sleep Quality using a wearable device | Evaluation of Physical Activity and Sleep Quality using a wearable device | Baseline | 
| Evaluation of Physical Activity and Sleep Quality using a wearable device | Evaluation of Physical Activity and Sleep Quality using a wearable device | Evaluation A', 6- months | 
| Evaluation of Physical Activity and Sleep Quality using a wearable device | Evaluation of Physical Activity and Sleep Quality using a wearable device | Evaluation B', 4 months after evaluation A' | 
| Foot Preference Questionnaire (FPQ) | Assessement of Foot Preference during static balance or activities using FPQ | Baseline | 
| Foot Preference Questionnaire (FPQ) | Assessement of Foot Preference during static balance or activities using FPQ | Evaluation A', 6- months | 
| Foot Preference Questionnaire (FPQ) | Assessement of Foot Preference during static balance or activities using FPQ | Evaluation B', 4 months after evaluation A' | 
| Fear of Falling and Activity Restriction (SAFE) | Assessement of Fear of Falling and Activity Restriction (SAFE) | Baseline | 
| Fear of Falling and Activity Restriction (SAFE) | Assessement of Fear of Falling and Activity Restriction (SAFE) | Evaluation A', 6- months | 
| Fear of Falling and Activity Restriction (SAFE) | Assessement of Fear of Falling and Activity Restriction (SAFE) | Evaluation B', 4 months after evaluation A' | 
| Trail Making Test | Assessement of visual attention and task switching using Trail Making Test | Baseline | 
| Trail Making Test | Assessement of visual attention and task switching using Trail Making Test | Evaluation A', 6- months | 
| Trail Making Test | Assessement of visual attention and task switching using Trail Making Test | Evaluation B', 4 months after evaluation A' | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Heart Failure, Cardiac Rehabilitation, Exercise