xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06036615</url>
    </required_header>
    <id_info>
      <org_study_id>110/2022</org_study_id>
      <nct_id>NCT06036615</nct_id>
    </id_info>
    <brief_title>The Effect of Exercise Training and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure</brief_title>
    <official_title>The Effect of Exercise Training Intervention and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aristotle University Of Thessaloniki</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aristotle University Of Thessaloniki</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Chronic Heart Failure (CHF) is the endpoint for some cardiac and respiratory conditions as&#xD;
        well as ageing affecting 1-2% of the global adult population. CHF requires a costly&#xD;
        treatment, frequent hospitalizations due its severe complications leading CHF eventually to a&#xD;
        frequent cause of morbidity and mortality worldwide. Another common complication of CHF is&#xD;
        frailty. Frailty is a complex clinical syndrome associated with CHF, resulting from multiple&#xD;
        organ impairment; physiological reserves decrease and vulnerability to stressors increase. Up&#xD;
        to 79% of PwCHF are frail leading to reduced functional capacity, quality of life (QoL), and&#xD;
        psychological well-being in CHF, and it is an independent predictor of mortality in&#xD;
        cardiovascular disease.&#xD;
  &#xD;
        The role of cardiac rehabilitation (CR) programs for PwCHF in preventing frailty has recently&#xD;
        draw the attention of the scientific world. Exercise constitutes a unique effective and&#xD;
        feasible non-pharmacological treatment for frailty in CHF as it offers such benefits that are&#xD;
        irreplaceable by medical treatment, with no side effects, and cost-effective treatment.&#xD;
        However, there are no studies examining the effect of training and detraining on muscle&#xD;
        strength and balance, fall prevention and fear of falling in PwCHF.&#xD;
  &#xD;
        The aim of this randomized controlled trial is to examine whether a 6-month combined aerobic,&#xD;
        strengthening and flexibility-mobility CR program and a 4-month de-training period will&#xD;
        affect frailty and fall risk in PwCHF. Ninety participants will be randomly allocated into&#xD;
        two groups: Group A (Exercise Group) will receive 3 sessions per week for 6 months and Group&#xD;
        B(Control Group) will continue their usual physical activity, without participating in&#xD;
        organized exercise programs.After the intervention for Group A' will follow a 4- month&#xD;
        de-training period and Group B' will continue their normal physical activity. Prior to the&#xD;
        group random allocation, part of our assessments at baseline and after 6 (Evaluation A') and&#xD;
        10 months (Evaluation B'), will include demographics and clinical history, physical&#xD;
        examination, ECG and echocardiogram, patients' ability to perform daily activities,&#xD;
        functional tests, static balance tests, body composition analysis and 24-h heart rhytm holter&#xD;
        monitoring. Moreover, we will use questionnaires assessing the QoL of people with CHF,&#xD;
        depression, anxiety, sleep quality, cognitive function, fear of falling, physical activity,&#xD;
        and sedentary behaviour.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">March 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Left Ventricular Systolic Function</measure>
      <time_frame>Baseline</time_frame>
      <description>Evaluation of Left Ventricular Ejection Fraction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Left Ventricular Systolic Function</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evaluation of Left Ventricular Ejection Fraction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Left Ventricular Systolic Function</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evaluation of Left Ventricular Ejection Fraction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cardiac Autonomic Nervous System Function</measure>
      <time_frame>Baseline</time_frame>
      <description>Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cardiac Autonomic Nervous System Function</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cardiac Autonomic Nervous System Function</measure>
      <time_frame>Evaluation B', 4 months</time_frame>
      <description>Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Composition Analysis</measure>
      <time_frame>Baseline</time_frame>
      <description>Evaluation of Body Composition Analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Composition Analysis</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evaluation of Body Composition Analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Composition Analysis</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evaluation of Body Composition Analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Six- Minute Walking Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Estimation of aerobic capacity through six minutes walking test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Six- Minute Walking Test</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Estimation of aerobic capacity through six minutes walking test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Six- Minute Walking Test</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Estimation of aerobic capacity through six minutes walking test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Timed- Up-and-Go Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Evaluation of functional capacity using Timed- Up-and-Go Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Timed- Up-and-Go Test</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evaluation of functional capacity using Timed- Up-and-Go Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Timed- Up-and-Go Test</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evaluation of functional capacity and mobility using Timed- Up-and-Go Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>4m-Walking Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Evalution of functional capacity and mobility using 4m-Walking Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>4m-Walking Test</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evalution of functional capacity and mobility using 4m-Walking Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>4m-Walking Test</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evalution of functional capacity and mobility using 4m-Walking Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>30-second Sit-to-Stand (STS)Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Evalution of functional capacity and mobility using 30-second STS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>30-second Sit-to-Stand (STS)Test</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evalution of functional capacity and mobility using 30-second STS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>30-second Sit-to-Stand (STS)Test</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evalution of functional capacity and mobility using 30-second STS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>5 Sit-to-Stand (5-STS)Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Evalution of functional capacity and mobility using 5 Sit-to-Stand</description>
    </primary_outcome>
    <primary_outcome>
      <measure>5 Sit-to-Stand (5-STS)Test</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evalution of functional capacity and mobility using 5 Sit-to-Stand</description>
    </primary_outcome>
    <primary_outcome>
      <measure>5 Sit-to-Stand (5-STS)Test</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evalution of functional capacity and mobility using 5 Sit-to-Stand</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mini-BEST Balance Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Evalution of balance using mini-BEST Balance Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mini-BEST Balance Test</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evalution of balance using mini-BEST Balance Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mini-BEST Balance Test</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evalution of balance using mini-BEST Balance Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Berg Balance Scale Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Evalution of balance using Berg Balance Scale Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Berg Balance Scale Test</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evalution of balance using Berg Balance Scale Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Berg Balance Scale Test</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evalution of balance using Berg Balance Scale Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Gait Assessment Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Evalution of Functional Gait using Functional Gait Assessement Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Gait Assessment Test</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evalution of Functional Gait using Functional Gait Assessement Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Gait Assessment Test</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evalution of Functional Gait using Functional Gait Assessement Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Static Balance Test using 3D Balance Force Plate</measure>
      <time_frame>Baseline</time_frame>
      <description>Evalution of Static Balance Test using 3D Balance Force Plate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Static Balance Test using 3D Balance Force Plate</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evalution of Static Balance Test using 3D Balance Force Plate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Static Balance Test using 3D Balance Force Plate</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evalution of Static Balance Test using 3D Balance Force Plate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Handgrip Strength</measure>
      <time_frame>Baseline</time_frame>
      <description>Evaluation of Handgrip Strength</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Handgrip Strength</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evaluation of Handgrip Strength</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Handgrip Strength</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evaluation of Handgrip Strength</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Isometric Strength of Upper and Lower Extremities</measure>
      <time_frame>Baseline</time_frame>
      <description>Evaluation of Isometric Strength of Upper and Lower Extremities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Isometric Strength of Upper and Lower Extremities</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evaluation of Isometric Strength of Upper and Lower Extremities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Isometric Strength of Upper and Lower Extremities</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evaluation of Isometric Strength of Upper and Lower Extremities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Isometric Pulling in a Semi-Squat Position</measure>
      <time_frame>Baseline</time_frame>
      <description>Evaluation of Isometric Pulling in a Semi-Squat Position</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Isometric Pulling in a Semi-Squat Position</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evaluation of Isometric Pulling in a Semi-Squat Position</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Isometric Pulling in a Semi-Squat Position</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evaluation of Isometric Pulling in a Semi-Squat Position</description>
    </primary_outcome>
    <primary_outcome>
      <measure>30- second Arm Curl Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Evaluation using Arm Curl Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>30- second Arm Curl Test</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evaluation using Arm Curl Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>30- second Arm Curl Test</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evaluation using Arm Curl Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sit-and-Reach Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Evaluation of mobility-flexibility using Sit-and-Reach Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sit-and-Reach Test</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evaluation of mobility-flexibility using Sit-and-Reach Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sit-and-Reach Test</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evaluation of mobility-flexibility using Sit-and-Reach Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Back Scratch Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Evaluation of mobility using Back Scratch Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Back Scratch Test</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evaluation of mobility using Back Scratch Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Back Scratch Test</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evaluation of mobility using Back Scratch Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>SF-36</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessement of Quality of Life using SF-36</description>
    </primary_outcome>
    <primary_outcome>
      <measure>SF-36</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Assessement of Quality of Life using SF-36</description>
    </primary_outcome>
    <primary_outcome>
      <measure>SF-36</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Assessement of Quality of Life using SF-36</description>
    </primary_outcome>
    <primary_outcome>
      <measure>I-PAQ</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessement of Physical Activity using I-PAQ</description>
    </primary_outcome>
    <primary_outcome>
      <measure>I-PAQ</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Assessement of Physical Activity using I-PAQ</description>
    </primary_outcome>
    <primary_outcome>
      <measure>I-PAQ</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Assessement of Physical Activity using I-PAQ</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Beck Depression Inventory</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessement of Depression using Beck Depression Inventory</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Beck Depression Inventory</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Assessement of Depression using Beck Depression Inventory</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Beck Depression Inventory</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Assessement of Depression using Beck Depression Inventory</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Falls Efficacy Scale (FES-I)</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessement of fear of falling using Falls Efficacy Scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Falls Efficacy Scale (FES-I)</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evaluation of fear of falling using Falls Efficacy Scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Falls Efficacy Scale (FES-I)</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Assessement of fear of falling using Falls Efficacy Scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Activities-specific Balance Confidence (ABC) Scale</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessement of Balance Confidence using ABC</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Activities-specific Balance Confidence (ABC) Scale</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Assessement of Balance Confidence using ABC</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Activities-specific Balance Confidence (ABC) Scale</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Assessement of Balance Confidence using ABC</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Minessota Living with Heart Failure (MLHFQ)</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessement of health-related quality of life using MLHFQ</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Minessota Living with Heart Failure (MLHFQ)</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Assessement of health-related quality of life using MLHFQ</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Minessota Living with Heart Failure (MLHFQ)</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Assessement of health-related quality of life using MLHFQ</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessement of Sleep Quality using PSQI</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Assessement of Sleep Quality using PSQI</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Assessement of Sleep Quality using PSQI</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intrinsic Motivation Inventory (IMI)</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessement of Intrinsic Motivation using IMI</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intrinsic Motivation Inventory (IMI)</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Assessement of Intrinsic Motivation using IMI</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intrinsic Motivation Inventory (IMI)</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Assessement of Intrinsic Motivation using IMI</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessement of Depression and Anxiety using HRSD and HARS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Assessement of Depression and Anxiety using HRSD and HARS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Assessement of Depression and Anxiety using HRSD and HARS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Montreal Cognitive Assessment Test (MOCA)</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessement of cognitive function using MOCA</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Montreal Cognitive Assessment Test (MOCA)</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Assessement of cognitive function using MOCA</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Montreal Cognitive Assessment Test (MOCA)</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Assessement of cognitive function using MOCA</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Falls</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessement of the number of weekly falls</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Falls</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Assessement of the number of weekly falls</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Falls</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Assessement of the number of weekly falls</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluation of Physical Activity and Sleep Quality using a wearable device</measure>
      <time_frame>Baseline</time_frame>
      <description>Evaluation of Physical Activity and Sleep Quality using a wearable device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluation of Physical Activity and Sleep Quality using a wearable device</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Evaluation of Physical Activity and Sleep Quality using a wearable device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluation of Physical Activity and Sleep Quality using a wearable device</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Evaluation of Physical Activity and Sleep Quality using a wearable device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Foot Preferance Questionnaire (FPQ)</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessement of Foot Preference during static balance or activities using FPQ</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Foot Preferance Questionnaire (FPQ)</measure>
      <time_frame>Evaluation A', 6- months</time_frame>
      <description>Assessement of Foot Preference during static balance or activities using FPQ</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Foot Preferance Questionnaire (FPQ)</measure>
      <time_frame>Evaluation B', 4 months after evaluation A'</time_frame>
      <description>Assessement of Foot Preference during static balance or activities using FPQ</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Chronic Heart Failure</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Exercise Group, 6- month combined aerobic, strengthening, mobiity- flexibility exercise intervention, 4- month de-training period</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control Group, 10- month normal physical activity, without participating in organized sports activities, no intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise Intervention</intervention_name>
      <description>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.</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 18 yrs. of either gender&#xD;
  &#xD;
            -  Confirmed diagnosis (by echocardiography) of HF reduced or preserved left ventricular&#xD;
               ejection fraction (HFrEF/ΗFpEF)&#xD;
  &#xD;
            -  Symptomatic New York Heart Association (NYHA) class II-III&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Acute Myocardial Infarction (&lt;4 weeks)&#xD;
  &#xD;
            -  Severe valvular diseases&#xD;
  &#xD;
            -  Potentially malignant arrhythmias&#xD;
  &#xD;
            -  Νeurological, or orthopedic limitations/non- ambulant status&#xD;
  &#xD;
            -  Cognitive disorders&#xD;
  &#xD;
            -  Poor regulation of comorbidities&#xD;
  &#xD;
            -  Already participating in organized exercise programs&#xD;
  &#xD;
            -  Current pregnancy&#xD;
  &#xD;
            -  NYHA function class IV&#xD;
  &#xD;
            -  Inability/unwillingness to give informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Evangelia Kouidi, Professor</last_name>
      <phone>+302310992189</phone>
      <email>kouidi@phed.auth.gr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Andriana Teloudi, PhDc</last_name>
      <phone>+306943411229</phone>
      <email>teloudia@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sports Medicine Laboratory, Aristotle University of Thessaloniki</name>
        <address>
          <city>Thessaloniki</city>
          <state>Thermi</state>
          <zip>57001</zip>
          <country>Greece</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Greece</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
      <investigator_full_name>Evangelia Kouidi</investigator_full_name>
      <investigator_title>Professor of Sports Medicine</investigator_title>
    </responsible_party>
    <keyword>Chronic Heart Failure, Exercise in Cardiac Rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06036615
  org study id: 110/2022
  nct id: NCT06036615
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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. Ninety 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 rhytm 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Left Ventricular Systolic Function
  time frame: Baseline
  description: Evaluation of Left Ventricular Ejection Fraction
  measure: Left Ventricular Systolic Function
  time frame: Evaluation A', 6- months
  description: Evaluation of Left Ventricular Ejection Fraction
  measure: Left Ventricular Systolic Function
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evaluation of Left Ventricular Ejection Fraction
  measure: Cardiac Autonomic Nervous System Function
  time frame: Baseline
  description: Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
  measure: Cardiac Autonomic Nervous System Function
  time frame: Evaluation A', 6- months
  description: Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
  measure: Cardiac Autonomic Nervous System Function
  time frame: Evaluation B', 4 months
  description: Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
  measure: Body Composition Analysis
  time frame: Baseline
  description: Evaluation of Body Composition Analysis
  measure: Body Composition Analysis
  time frame: Evaluation A', 6- months
  description: Evaluation of Body Composition Analysis
  measure: Body Composition Analysis
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evaluation of Body Composition Analysis
  measure: Six- Minute Walking Test
  time frame: Baseline
  description: Estimation of aerobic capacity through six minutes walking test
  measure: Six- Minute Walking Test
  time frame: Evaluation A', 6- months
  description: Estimation of aerobic capacity through six minutes walking test
  measure: Six- Minute Walking Test
  time frame: Evaluation B', 4 months after evaluation A'
  description: Estimation of aerobic capacity through six minutes walking test
  measure: Timed- Up-and-Go Test
  time frame: Baseline
  description: Evaluation of functional capacity using Timed- Up-and-Go Test
  measure: Timed- Up-and-Go Test
  time frame: Evaluation A', 6- months
  description: Evaluation of functional capacity using Timed- Up-and-Go Test
  measure: Timed- Up-and-Go Test
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evaluation of functional capacity and mobility using Timed- Up-and-Go Test
  measure: 4m-Walking Test
  time frame: Baseline
  description: Evalution of functional capacity and mobility using 4m-Walking Test
  measure: 4m-Walking Test
  time frame: Evaluation A', 6- months
  description: Evalution of functional capacity and mobility using 4m-Walking Test
  measure: 4m-Walking Test
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evalution of functional capacity and mobility using 4m-Walking Test
  measure: 30-second Sit-to-Stand (STS)Test
  time frame: Baseline
  description: Evalution of functional capacity and mobility using 30-second STS
  measure: 30-second Sit-to-Stand (STS)Test
  time frame: Evaluation A', 6- months
  description: Evalution of functional capacity and mobility using 30-second STS
  measure: 30-second Sit-to-Stand (STS)Test
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evalution of functional capacity and mobility using 30-second STS
  measure: 5 Sit-to-Stand (5-STS)Test
  time frame: Baseline
  description: Evalution of functional capacity and mobility using 5 Sit-to-Stand
  measure: 5 Sit-to-Stand (5-STS)Test
  time frame: Evaluation A', 6- months
  description: Evalution of functional capacity and mobility using 5 Sit-to-Stand
  measure: 5 Sit-to-Stand (5-STS)Test
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evalution of functional capacity and mobility using 5 Sit-to-Stand
  measure: mini-BEST Balance Test
  time frame: Baseline
  description: Evalution of balance using mini-BEST Balance Test
  measure: mini-BEST Balance Test
  time frame: Evaluation A', 6- months
  description: Evalution of balance using mini-BEST Balance Test
  measure: mini-BEST Balance Test
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evalution of balance using mini-BEST Balance Test
  measure: Berg Balance Scale Test
  time frame: Baseline
  description: Evalution of balance using Berg Balance Scale Test
  measure: Berg Balance Scale Test
  time frame: Evaluation A', 6- months
  description: Evalution of balance using Berg Balance Scale Test
  measure: Berg Balance Scale Test
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evalution of balance using Berg Balance Scale Test
  measure: Functional Gait Assessment Test
  time frame: Baseline
  description: Evalution of Functional Gait using Functional Gait Assessement Test
  measure: Functional Gait Assessment Test
  time frame: Evaluation A', 6- months
  description: Evalution of Functional Gait using Functional Gait Assessement Test
  measure: Functional Gait Assessment Test
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evalution of Functional Gait using Functional Gait Assessement Test
  measure: Static Balance Test using 3D Balance Force Plate
  time frame: Baseline
  description: Evalution of Static Balance Test using 3D Balance Force Plate
  measure: Static Balance Test using 3D Balance Force Plate
  time frame: Evaluation A', 6- months
  description: Evalution of Static Balance Test using 3D Balance Force Plate
  measure: Static Balance Test using 3D Balance Force Plate
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evalution of Static Balance Test using 3D Balance Force Plate
  measure: Handgrip Strength
  time frame: Baseline
  description: Evaluation of Handgrip Strength
  measure: Handgrip Strength
  time frame: Evaluation A', 6- months
  description: Evaluation of Handgrip Strength
  measure: Handgrip Strength
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evaluation of Handgrip Strength
  measure: Isometric Strength of Upper and Lower Extremities
  time frame: Baseline
  description: Evaluation of Isometric Strength of Upper and Lower Extremities
  measure: Isometric Strength of Upper and Lower Extremities
  time frame: Evaluation A', 6- months
  description: Evaluation of Isometric Strength of Upper and Lower Extremities
  measure: Isometric Strength of Upper and Lower Extremities
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evaluation of Isometric Strength of Upper and Lower Extremities
  measure: Isometric Pulling in a Semi-Squat Position
  time frame: Baseline
  description: Evaluation of Isometric Pulling in a Semi-Squat Position
  measure: Isometric Pulling in a Semi-Squat Position
  time frame: Evaluation A', 6- months
  description: Evaluation of Isometric Pulling in a Semi-Squat Position
  measure: Isometric Pulling in a Semi-Squat Position
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evaluation of Isometric Pulling in a Semi-Squat Position
  measure: 30- second Arm Curl Test
  time frame: Baseline
  description: Evaluation using Arm Curl Test
  measure: 30- second Arm Curl Test
  time frame: Evaluation A', 6- months
  description: Evaluation using Arm Curl Test
  measure: 30- second Arm Curl Test
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evaluation using Arm Curl Test
  measure: Sit-and-Reach Test
  time frame: Baseline
  description: Evaluation of mobility-flexibility using Sit-and-Reach Test
  measure: Sit-and-Reach Test
  time frame: Evaluation A', 6- months
  description: Evaluation of mobility-flexibility using Sit-and-Reach Test
  measure: Sit-and-Reach Test
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evaluation of mobility-flexibility using Sit-and-Reach Test
  measure: Back Scratch Test
  time frame: Baseline
  description: Evaluation of mobility using Back Scratch Test
  measure: Back Scratch Test
  time frame: Evaluation A', 6- months
  description: Evaluation of mobility using Back Scratch Test
  measure: Back Scratch Test
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evaluation of mobility using Back Scratch Test
  measure: SF-36
  time frame: Baseline
  description: Assessement of Quality of Life using SF-36
  measure: SF-36
  time frame: Evaluation A', 6- months
  description: Assessement of Quality of Life using SF-36
  measure: SF-36
  time frame: Evaluation B', 4 months after evaluation A'
  description: Assessement of Quality of Life using SF-36
  measure: I-PAQ
  time frame: Baseline
  description: Assessement of Physical Activity using I-PAQ
  measure: I-PAQ
  time frame: Evaluation A', 6- months
  description: Assessement of Physical Activity using I-PAQ
  measure: I-PAQ
  time frame: Evaluation B', 4 months after evaluation A'
  description: Assessement of Physical Activity using I-PAQ
  measure: Beck Depression Inventory
  time frame: Baseline
  description: Assessement of Depression using Beck Depression Inventory
  measure: Beck Depression Inventory
  time frame: Evaluation A', 6- months
  description: Assessement of Depression using Beck Depression Inventory
  measure: Beck Depression Inventory
  time frame: Evaluation B', 4 months after evaluation A'
  description: Assessement of Depression using Beck Depression Inventory
  measure: Falls Efficacy Scale (FES-I)
  time frame: Baseline
  description: Assessement of fear of falling using Falls Efficacy Scale
  measure: Falls Efficacy Scale (FES-I)
  time frame: Evaluation A', 6- months
  description: Evaluation of fear of falling using Falls Efficacy Scale
  measure: Falls Efficacy Scale (FES-I)
  time frame: Evaluation B', 4 months after evaluation A'
  description: Assessement of fear of falling using Falls Efficacy Scale
  measure: Activities-specific Balance Confidence (ABC) Scale
  time frame: Baseline
  description: Assessement of Balance Confidence using ABC
  measure: Activities-specific Balance Confidence (ABC) Scale
  time frame: Evaluation A', 6- months
  description: Assessement of Balance Confidence using ABC
  measure: Activities-specific Balance Confidence (ABC) Scale
  time frame: Evaluation B', 4 months after evaluation A'
  description: Assessement of Balance Confidence using ABC
  measure: Minessota Living with Heart Failure (MLHFQ)
  time frame: Baseline
  description: Assessement of health-related quality of life using MLHFQ
  measure: Minessota Living with Heart Failure (MLHFQ)
  time frame: Evaluation A', 6- months
  description: Assessement of health-related quality of life using MLHFQ
  measure: Minessota Living with Heart Failure (MLHFQ)
  time frame: Evaluation B', 4 months after evaluation A'
  description: Assessement of health-related quality of life using MLHFQ
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: Baseline
  description: Assessement of Sleep Quality using PSQI
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: Evaluation A', 6- months
  description: Assessement of Sleep Quality using PSQI
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: Evaluation B', 4 months after evaluation A'
  description: Assessement of Sleep Quality using PSQI
  measure: Intrinsic Motivation Inventory (IMI)
  time frame: Baseline
  description: Assessement of Intrinsic Motivation using IMI
  measure: Intrinsic Motivation Inventory (IMI)
  time frame: Evaluation A', 6- months
  description: Assessement of Intrinsic Motivation using IMI
  measure: Intrinsic Motivation Inventory (IMI)
  time frame: Evaluation B', 4 months after evaluation A'
  description: Assessement of Intrinsic Motivation using IMI
  measure: Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
  time frame: Baseline
  description: Assessement of Depression and Anxiety using HRSD and HARS
  measure: Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
  time frame: Evaluation A', 6- months
  description: Assessement of Depression and Anxiety using HRSD and HARS
  measure: Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
  time frame: Evaluation B', 4 months after evaluation A'
  description: Assessement of Depression and Anxiety using HRSD and HARS
  measure: Montreal Cognitive Assessment Test (MOCA)
  time frame: Baseline
  description: Assessement of cognitive function using MOCA
  measure: Montreal Cognitive Assessment Test (MOCA)
  time frame: Evaluation A', 6- months
  description: Assessement of cognitive function using MOCA
  measure: Montreal Cognitive Assessment Test (MOCA)
  time frame: Evaluation B', 4 months after evaluation A'
  description: Assessement of cognitive function using MOCA
  measure: Falls
  time frame: Baseline
  description: Assessement of the number of weekly falls
  measure: Falls
  time frame: Evaluation A', 6- months
  description: Assessement of the number of weekly falls
  measure: Falls
  time frame: Evaluation B', 4 months after evaluation A'
  description: Assessement of the number of weekly falls
  measure: Evaluation of Physical Activity and Sleep Quality using a wearable device
  time frame: Baseline
  description: Evaluation of Physical Activity and Sleep Quality using a wearable device
  measure: Evaluation of Physical Activity and Sleep Quality using a wearable device
  time frame: Evaluation A', 6- months
  description: Evaluation of Physical Activity and Sleep Quality using a wearable device
  measure: Evaluation of Physical Activity and Sleep Quality using a wearable device
  time frame: Evaluation B', 4 months after evaluation A'
  description: Evaluation of Physical Activity and Sleep Quality using a wearable device
  measure: Foot Preferance Questionnaire (FPQ)
  time frame: Baseline
  description: Assessement of Foot Preference during static balance or activities using FPQ
  measure: Foot Preferance Questionnaire (FPQ)
  time frame: Evaluation A', 6- months
  description: Assessement of Foot Preference during static balance or activities using FPQ
  measure: Foot Preferance Questionnaire (FPQ)
  time frame: Evaluation B', 4 months after evaluation A'
  description: Assessement of Foot Preference during static balance or activities using FPQ
  arm group label: Group A
  arm group type: Experimental
  description: Exercise Group, 6- month combined aerobic, strengthening, mobiity- flexibility exercise intervention, 4- month de-training period
  arm group label: Group B
  arm group type: No Intervention
  description: Control Group, 10- month normal physical activity, without participating in organized sports activities, no intervention
  intervention type: Other
  intervention name: Exercise Intervention
  description: 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.
  arm group label: Group A
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Evangelia Kouidi, Professor
  phone: +302310992189
  email: kouidi@phed.auth.gr
  last name: Andriana Teloudi, PhDc
  phone: +306943411229
  email: teloudia@gmail.com
  facility: 
  country: Greece
  responsible party type: Principal Investigator
  investigator affiliation: Aristotle University Of Thessaloniki
  investigator full name: Evangelia Kouidi
  investigator title: Professor of Sports Medicine
  mesh term: Heart Failure
  mesh term: Frailty