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

Primary Purpose

Chronic Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, Cardiac Rehabilitation, Exercise

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sports Medicine Laboratory, Aristotle University of Thessaloniki

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

Exercise Group, 6- month combined aerobic, strengthening, mobility- flexibility exercise intervention, 4- month de-training period

Control Group, 10- month normal physical activity, without participating in organized sports activities, no intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 7, 2023
Last Updated
October 6, 2023
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT06036615
Brief Title
The Effect of Exercise Training and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure
Official Title
The Effect of Exercise Training Intervention and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Chronic Heart Failure, Cardiac Rehabilitation, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Exercise Group, 6- month combined aerobic, strengthening, mobility- flexibility exercise intervention, 4- month de-training period
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Control Group, 10- month normal physical activity, without participating in organized sports activities, no intervention
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
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.
Primary Outcome Measure Information:
Title
Left Ventricular Systolic Function
Description
Evaluation of Left Ventricular Ejection Fraction
Time Frame
Baseline
Title
Left Ventricular Systolic Function
Description
Evaluation of Left Ventricular Ejection Fraction
Time Frame
Evaluation A', 6- months
Title
Left Ventricular Systolic Function
Description
Evaluation of Left Ventricular Ejection Fraction
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Cardiac Autonomic Nervous System Function
Description
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Time Frame
Baseline
Title
Cardiac Autonomic Nervous System Function
Description
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Time Frame
Evaluation A', 6- months
Title
Cardiac Autonomic Nervous System Function
Description
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Time Frame
Evaluation B', 4 months
Title
Body Composition Analysis
Description
Evaluation of Body Composition Analysis
Time Frame
Baseline
Title
Body Composition Analysis
Description
Evaluation of Body Composition Analysis
Time Frame
Evaluation A', 6- months
Title
Body Composition Analysis
Description
Evaluation of Body Composition Analysis
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Six- Minute Walking Test
Description
Estimation of aerobic capacity through six minutes walking test
Time Frame
Baseline
Title
Six- Minute Walking Test
Description
Estimation of aerobic capacity through six minutes walking test
Time Frame
Evaluation A', 6- months
Title
Six- Minute Walking Test
Description
Estimation of aerobic capacity through six minutes walking test
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Timed- Up-and-Go Test
Description
Evaluation of functional capacity using Timed- Up-and-Go Test
Time Frame
Baseline
Title
Timed- Up-and-Go Test
Description
Evaluation of functional capacity using Timed- Up-and-Go Test
Time Frame
Evaluation A', 6- months
Title
Timed- Up-and-Go Test
Description
Evaluation of functional capacity and mobility using Timed- Up-and-Go Test
Time Frame
Evaluation B', 4 months after evaluation A'
Title
4m-Walking Test
Description
Evaluation of functional capacity and mobility using 4m-Walking Test
Time Frame
Baseline
Title
4m-Walking Test
Description
Evaluation of functional capacity and mobility using 4m-Walking Test
Time Frame
Evaluation A', 6- months
Title
4m-Walking Test
Description
Evaluation of functional capacity and mobility using 4m-Walking Test
Time Frame
Evaluation B', 4 months after evaluation A'
Title
30-second Sit-to-Stand (STS)Test
Description
Evaluation of functional capacity and mobility using 30-second STS
Time Frame
Baseline
Title
30-second Sit-to-Stand (STS)Test
Description
Evaluation of functional capacity and mobility using 30-second STS
Time Frame
Evaluation A', 6- months
Title
30-second Sit-to-Stand (STS)Test
Description
Evaluation of functional capacity and mobility using 30-second STS
Time Frame
Evaluation B', 4 months after evaluation A'
Title
5 Sit-to-Stand (5-STS)Test
Description
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
Time Frame
Baseline
Title
5 Sit-to-Stand (5-STS)Test
Description
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
Time Frame
Evaluation A', 6- months
Title
5 Sit-to-Stand (5-STS)Test
Description
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
Time Frame
Evaluation B', 4 months after evaluation A'
Title
mini-BEST Balance Test
Description
Evaluation of balance using mini-BEST Balance Test
Time Frame
Baseline
Title
mini-BEST Balance Test
Description
Evaluation of balance using mini-BEST Balance Test
Time Frame
Evaluation A', 6- months
Title
mini-BEST Balance Test
Description
Evaluation of balance using mini-BEST Balance Test
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Berg Balance Scale Test
Description
Evaluation of balance using Berg Balance Scale Test
Time Frame
Baseline
Title
Berg Balance Scale Test
Description
Evaluation of balance using Berg Balance Scale Test
Time Frame
Evaluation A', 6- months
Title
Berg Balance Scale Test
Description
Evaluation of balance using Berg Balance Scale Test
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Functional Gait Assessment Test
Description
Evaluation of Functional Gait using Functional Gait Assessement Test
Time Frame
Baseline
Title
Functional Gait Assessment Test
Description
Evaluation of Functional Gait using Functional Gait Assessement Test
Time Frame
Evaluation A', 6- months
Title
Functional Gait Assessment Test
Description
Evaluation of Functional Gait using Functional Gait Assessement Test
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Static Balance Test using 3D Balance Force Plate
Description
Evaluation of Static Balance Test using 3D Balance Force Plate
Time Frame
Baseline
Title
Static Balance Test using 3D Balance Force Plate
Description
Evaluation of Static Balance Test using 3D Balance Force Plate
Time Frame
Evaluation A', 6- months
Title
Static Balance Test using 3D Balance Force Plate
Description
Evaluation of Static Balance Test using 3D Balance Force Plate
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Handgrip Strength
Description
Evaluation of Handgrip Strength
Time Frame
Baseline
Title
Handgrip Strength
Description
Evaluation of Handgrip Strength
Time Frame
Evaluation A', 6- months
Title
Handgrip Strength
Description
Evaluation of Handgrip Strength
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Strength of Upper and Lower Extremities
Description
Evaluation of Strength of Upper and Lower Extremities
Time Frame
Baseline
Title
Strength of Upper and Lower Extremities
Description
Evaluation of Strength of Upper and Lower Extremities
Time Frame
Evaluation A', 6- months
Title
Strength of Upper and Lower Extremities
Description
Evaluation of Strength of Upper and Lower Extremities
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Isometric Pulling in a Semi-Squat Position
Description
Evaluation of Isometric Pulling in a Semi-Squat Position
Time Frame
Baseline
Title
Isometric Pulling in a Semi-Squat Position
Description
Evaluation of Isometric Pulling in a Semi-Squat Position
Time Frame
Evaluation A', 6- months
Title
Isometric Pulling in a Semi-Squat Position
Description
Evaluation of Isometric Pulling in a Semi-Squat Position
Time Frame
Evaluation B', 4 months after evaluation A'
Title
30- second Arm Curl Test
Description
Evaluation using Arm Curl Test
Time Frame
Baseline
Title
30- second Arm Curl Test
Description
Evaluation using Arm Curl Test
Time Frame
Evaluation A', 6- months
Title
30- second Arm Curl Test
Description
Evaluation using Arm Curl Test
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Sit-and-Reach Test
Description
Evaluation of mobility-flexibility using Sit-and-Reach Test
Time Frame
Baseline
Title
Sit-and-Reach Test
Description
Evaluation of mobility-flexibility using Sit-and-Reach Test
Time Frame
Evaluation A', 6- months
Title
Sit-and-Reach Test
Description
Evaluation of mobility-flexibility using Sit-and-Reach Test
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Back Scratch Test
Description
Evaluation of mobility using Back Scratch Test
Time Frame
Baseline
Title
Back Scratch Test
Description
Evaluation of mobility using Back Scratch Test
Time Frame
Evaluation A', 6- months
Title
Back Scratch Test
Description
Evaluation of mobility using Back Scratch Test
Time Frame
Evaluation B', 4 months after evaluation A'
Title
SF-36
Description
Assessement of Quality of Life using SF-36
Time Frame
Baseline
Title
SF-36
Description
Assessement of Quality of Life using SF-36
Time Frame
Evaluation A', 6- months
Title
SF-36
Description
Assessement of Quality of Life using SF-36
Time Frame
Evaluation B', 4 months after evaluation A'
Title
I-PAQ
Description
Assessement of Physical Activity using I-PAQ
Time Frame
Baseline
Title
I-PAQ
Description
Assessement of Physical Activity using I-PAQ
Time Frame
Evaluation A', 6- months
Title
I-PAQ
Description
Assessement of Physical Activity using I-PAQ
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Beck Depression Inventory
Description
Assessement of Depression using Beck Depression Inventory
Time Frame
Baseline
Title
Beck Depression Inventory
Description
Assessement of Depression using Beck Depression Inventory
Time Frame
Evaluation A', 6- months
Title
Beck Depression Inventory
Description
Assessement of Depression using Beck Depression Inventory
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Falls Efficacy Scale (FES-I)
Description
Assessement of fear of falling using Falls Efficacy Scale
Time Frame
Baseline
Title
Falls Efficacy Scale (FES-I)
Description
Evaluation of fear of falling using Falls Efficacy Scale
Time Frame
Evaluation A', 6- months
Title
Falls Efficacy Scale (FES-I)
Description
Assessement of fear of falling using Falls Efficacy Scale
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Activities-specific Balance Confidence (ABC) Scale
Description
Assessement of Balance Confidence using ABC
Time Frame
Baseline
Title
Activities-specific Balance Confidence (ABC) Scale
Description
Assessement of Balance Confidence using ABC
Time Frame
Evaluation A', 6- months
Title
Activities-specific Balance Confidence (ABC) Scale
Description
Assessement of Balance Confidence using ABC
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Minnesota Living with Heart Failure (MLHFQ)
Description
Assessement of health-related quality of life using MLHFQ
Time Frame
Baseline
Title
Minnesota Living with Heart Failure (MLHFQ)
Description
Assessement of health-related quality of life using MLHFQ
Time Frame
Evaluation A', 6- months
Title
Minnesota Living with Heart Failure (MLHFQ)
Description
Assessement of health-related quality of life using MLHFQ
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Assessement of Sleep Quality using PSQI
Time Frame
Baseline
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Assessement of Sleep Quality using PSQI
Time Frame
Evaluation A', 6- months
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Assessement of Sleep Quality using PSQI
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Intrinsic Motivation Inventory (IMI)
Description
Assessement of Intrinsic Motivation using IMI
Time Frame
Baseline
Title
Intrinsic Motivation Inventory (IMI)
Description
Assessement of Intrinsic Motivation using IMI
Time Frame
Evaluation A', 6- months
Title
Intrinsic Motivation Inventory (IMI)
Description
Assessement of Intrinsic Motivation using IMI
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Description
Assessement of Depression and Anxiety using HRSD and HARS
Time Frame
Baseline
Title
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Description
Assessement of Depression and Anxiety using HRSD and HARS
Time Frame
Evaluation A', 6- months
Title
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Description
Assessement of Depression and Anxiety using HRSD and HARS
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Montreal Cognitive Assessment Test (MOCA)
Description
Assessement of cognitive function using MOCA
Time Frame
Baseline
Title
Montreal Cognitive Assessment Test (MOCA)
Description
Assessement of cognitive function using MOCA
Time Frame
Evaluation A', 6- months
Title
Montreal Cognitive Assessment Test (MOCA)
Description
Assessement of cognitive function using MOCA
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Falls
Description
Assessement of the number of weekly falls
Time Frame
Baseline
Title
Falls
Description
Assessement of the number of weekly falls
Time Frame
Evaluation A', 6- months
Title
Falls
Description
Assessement of the number of weekly falls
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Evaluation of Physical Activity and Sleep Quality using a wearable device
Description
Evaluation of Physical Activity and Sleep Quality using a wearable device
Time Frame
Baseline
Title
Evaluation of Physical Activity and Sleep Quality using a wearable device
Description
Evaluation of Physical Activity and Sleep Quality using a wearable device
Time Frame
Evaluation A', 6- months
Title
Evaluation of Physical Activity and Sleep Quality using a wearable device
Description
Evaluation of Physical Activity and Sleep Quality using a wearable device
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Foot Preference Questionnaire (FPQ)
Description
Assessement of Foot Preference during static balance or activities using FPQ
Time Frame
Baseline
Title
Foot Preference Questionnaire (FPQ)
Description
Assessement of Foot Preference during static balance or activities using FPQ
Time Frame
Evaluation A', 6- months
Title
Foot Preference Questionnaire (FPQ)
Description
Assessement of Foot Preference during static balance or activities using FPQ
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Fear of Falling and Activity Restriction (SAFE)
Description
Assessement of Fear of Falling and Activity Restriction (SAFE)
Time Frame
Baseline
Title
Fear of Falling and Activity Restriction (SAFE)
Description
Assessement of Fear of Falling and Activity Restriction (SAFE)
Time Frame
Evaluation A', 6- months
Title
Fear of Falling and Activity Restriction (SAFE)
Description
Assessement of Fear of Falling and Activity Restriction (SAFE)
Time Frame
Evaluation B', 4 months after evaluation A'
Title
Trail Making Test
Description
Assessement of visual attention and task switching using Trail Making Test
Time Frame
Baseline
Title
Trail Making Test
Description
Assessement of visual attention and task switching using Trail Making Test
Time Frame
Evaluation A', 6- months
Title
Trail Making Test
Description
Assessement of visual attention and task switching using Trail Making Test
Time Frame
Evaluation B', 4 months after evaluation A'

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evangelia Kouidi, Professor
Phone
+302310992189
Email
kouidi@phed.auth.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Andriana Teloudi, PhDc
Email
teloudia@phed.auth.gr
Facility Information:
Facility Name
Sports Medicine Laboratory, Aristotle University of Thessaloniki
City
Thessaloniki
State/Province
Thermi
ZIP/Postal Code
57001
Country
Greece

12. IPD Sharing Statement

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

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