Chronic Heart Failure (CHF) is the endpoint for some cardiac and respiratory conditions as well as ageing affecting 1-2% of the global adult population. CHF requires a costly treatment, frequent hospitalizations due its severe complications leading CHF eventually to a frequent cause of morbidity and mortality worldwide. Another common complication of CHF is frailty. Frailty is a complex clinical syndrome associated with CHF, resulting from multiple organ impairment; physiological reserves decrease and vulnerability to stressors increase. Up to 79% of PwCHF are frail leading to reduced functional capacity, quality of life (QoL), and psychological well-being in CHF, and it is an independent predictor of mortality in cardiovascular disease. The role of cardiac rehabilitation (CR) programs for PwCHF in preventing frailty has recently draw the attention of the scientific world. Exercise constitutes a unique effective and feasible non-pharmacological treatment for frailty in CHF as it offers such benefits that are irreplaceable by medical treatment, with no side effects, and cost-effective treatment. However, there are no studies examining the effect of training and detraining on muscle strength and balance, fall prevention and fear of falling in PwCHF. The aim of this randomized controlled trial is to examine whether a 6-month combined aerobic, strengthening and flexibility-mobility CR program and a 3-month de-training period will affect frailty and fall risk in PwCHF. One hundred participants will be randomly allocated into two groups: Group A (Exercise Group) will receive 3 sessions per week for 6 months and Group B(Control Group) will continue their usual physical activity, without participating in organized exercise programs.After the intervention for Group A' will follow a 3- month de-training period and Group B' will continue their normal physical activity. Prior to the group random allocation, part of our assessments at baseline and after 6 (Evaluation A') and 10 months (Evaluation B'), will include demographics and clinical history, physical examination, ECG and echocardiogram, patients' ability to perform daily activities, functional tests, static balance tests, body composition analysis and 24-h heart rhythm holter monitoring. Moreover, we will use questionnaires assessing the QoL of people with CHF, depression, anxiety, sleep quality, cognitive function, fear of falling, physical activity, and sedentary behaviour.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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 3-month de-training period, continuing their normal physical activity.
Sports Medicine Laboratory, Aristotle University of Thessaloniki
Thessaloniki, Thermi, Greece
RECRUITINGLeft Ventricular Systolic Function
Evaluation of Left Ventricular Ejection Fraction
Time frame: Baseline
Left Ventricular Systolic Function
Evaluation of Left Ventricular Ejection Fraction
Time frame: Evaluation A', 6- months
Left Ventricular Systolic Function
Evaluation of Left Ventricular Ejection Fraction
Time frame: Evaluation B', 3 months after evaluation A'
Cardiac Autonomic Nervous System Function
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Time frame: Baseline
Cardiac Autonomic Nervous System Function
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Time frame: Evaluation A', 6- months
Cardiac Autonomic Nervous System Function
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Time frame: Evaluation B', 3 months
Body Composition Analysis
Evaluation of Body Composition Analysis
Time frame: Baseline
Body Composition Analysis
Evaluation of Body Composition Analysis
Time frame: Evaluation A', 3- months
Body Composition Analysis
Evaluation of Body Composition Analysis
Time frame: Evaluation B', 3 months after evaluation A'
Six- Minute Walking Test
Estimation of aerobic capacity through six minutes walking test
Time frame: Baseline
Six- Minute Walking Test
Estimation of aerobic capacity through six minutes walking test
Time frame: Evaluation A', 6- months
Six- Minute Walking Test
Estimation of aerobic capacity through six minutes walking test
Time frame: Evaluation B', 3 months after evaluation A'
Timed- Up-and-Go Test
Evaluation of functional capacity using Timed- Up-and-Go Test
Time frame: Baseline
Timed- Up-and-Go Test
Evaluation of functional capacity using Timed- Up-and-Go Test
Time frame: Evaluation A', 6- months
Timed- Up-and-Go Test
Evaluation of functional capacity and mobility using Timed- Up-and-Go Test
Time frame: Evaluation B', 3 months after evaluation A'
4m-Walking Test
Evaluation of functional capacity and mobility using 4m-Walking Test
Time frame: Baseline
4m-Walking Test
Evaluation of functional capacity and mobility using 4m-Walking Test
Time frame: Evaluation A', 6- months
4m-Walking Test
Evaluation of functional capacity and mobility using 4m-Walking Test
Time frame: Evaluation B', 3 months after evaluation A'
30-second Sit-to-Stand (STS)Test
Evaluation of functional capacity and mobility using 30-second STS
Time frame: Baseline
30-second Sit-to-Stand (STS)Test
Evaluation of functional capacity and mobility using 30-second STS
Time frame: Evaluation A', 6- months
30-second Sit-to-Stand (STS)Test
Evaluation of functional capacity and mobility using 30-second STS
Time frame: Evaluation B', 3 months after evaluation A'
5 Sit-to-Stand (5-STS)Test
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
Time frame: Baseline
5 Sit-to-Stand (5-STS)Test
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
Time frame: Evaluation A', 6- months
5 Sit-to-Stand (5-STS)Test
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
Time frame: Evaluation B', 3 months after evaluation A'
mini-BEST Balance Test
Evaluation of balance using mini-BEST Balance Test
Time frame: Baseline
mini-BEST Balance Test
Evaluation of balance using mini-BEST Balance Test
Time frame: Evaluation A', 6- months
mini-BEST Balance Test
Evaluation of balance using mini-BEST Balance Test
Time frame: Evaluation B', 3 months after evaluation A'
Berg Balance Scale Test
Evaluation of balance using Berg Balance Scale Test
Time frame: Baseline
Berg Balance Scale Test
Evaluation of balance using Berg Balance Scale Test
Time frame: Evaluation A', 6- months
Berg Balance Scale Test
Evaluation of balance using Berg Balance Scale Test
Time frame: Evaluation B', 3 months after evaluation A'
Functional Gait Assessment Test
Evaluation of Functional Gait using Functional Gait Assessement Test
Time frame: Baseline
Functional Gait Assessment Test
Evaluation of Functional Gait using Functional Gait Assessement Test
Time frame: Evaluation A', 6- months
Functional Gait Assessment Test
Evaluation of Functional Gait using Functional Gait Assessement Test
Time frame: Evaluation B', 3 months after evaluation A'
Static Balance Test using 3D Balance Force Plate
Evaluation of Static Balance Test using 3D Balance Force Plate
Time frame: Baseline
Static Balance Test using 3D Balance Force Plate
Evaluation of Static Balance Test using 3D Balance Force Plate
Time frame: Evaluation A', 6- months
Static Balance Test using 3D Balance Force Plate
Evaluation of Static Balance Test using 3D Balance Force Plate
Time frame: Evaluation B', 3 months after evaluation A'
Handgrip Strength
Evaluation of Handgrip Strength
Time frame: Baseline
Handgrip Strength
Evaluation of Handgrip Strength
Time frame: Evaluation A', 6- months
Handgrip Strength
Evaluation of Handgrip Strength
Time frame: Evaluation B', 3 months after evaluation A'
Strength of Upper and Lower Extremities
Evaluation of Strength of Upper and Lower Extremities
Time frame: Baseline
Strength of Upper and Lower Extremities
Evaluation of Strength of Upper and Lower Extremities
Time frame: Evaluation A', 6- months
Strength of Upper and Lower Extremities
Evaluation of Strength of Upper and Lower Extremities
Time frame: Evaluation B', 3 months after evaluation A'
Isometric Pulling in a Semi-Squat Position
Evaluation of Isometric Pulling in a Semi-Squat Position
Time frame: Baseline
Isometric Pulling in a Semi-Squat Position
Evaluation of Isometric Pulling in a Semi-Squat Position
Time frame: Evaluation A', 6- months
Isometric Pulling in a Semi-Squat Position
Evaluation of Isometric Pulling in a Semi-Squat Position
Time frame: Evaluation B', 3 months after evaluation A'
30- second Arm Curl Test
Evaluation using Arm Curl Test
Time frame: Baseline
30- second Arm Curl Test
Evaluation using Arm Curl Test
Time frame: Evaluation A', 6- months
30- second Arm Curl Test
Evaluation using Arm Curl Test
Time frame: Evaluation B', 3 months after evaluation A'
Sit-and-Reach Test
Evaluation of mobility-flexibility using Sit-and-Reach Test
Time frame: Baseline
Sit-and-Reach Test
Evaluation of mobility-flexibility using Sit-and-Reach Test
Time frame: Evaluation A', 6- months
Sit-and-Reach Test
Evaluation of mobility-flexibility using Sit-and-Reach Test
Time frame: Evaluation B', 3 months after evaluation A'
Back Scratch Test
Evaluation of mobility using Back Scratch Test
Time frame: Baseline
Back Scratch Test
Evaluation of mobility using Back Scratch Test
Time frame: Evaluation A', 6- months
Back Scratch Test
Evaluation of mobility using Back Scratch Test
Time frame: Evaluation B', 3 months after evaluation A'
SF-36
Assessment of Quality of Life using SF-36
Time frame: Baseline
SF-36
Assessment of Quality of Life using SF-36
Time frame: Evaluation A', 6- months
SF-36
Assessment of Quality of Life using SF-36
Time frame: Evaluation B', 3 months after evaluation A'
I-PAQ
Assessment of Physical Activity using I-PAQ
Time frame: Baseline
I-PAQ
Assessment of Physical Activity using I-PAQ
Time frame: Evaluation A', 6- months
I-PAQ
Assessment of Physical Activity using I-PAQ
Time frame: Evaluation B', 3 months after evaluation A'
Beck Depression Inventory
Assessment of Depression using Beck Depression Inventory
Time frame: Baseline
Beck Depression Inventory
Assessment of Depression using Beck Depression Inventory
Time frame: Evaluation A', 6- months
Beck Depression Inventory
Assessment of Depression using Beck Depression Inventory
Time frame: Evaluation B', 3 months after evaluation A'
Falls Efficacy Scale (FES-I)
Assessment of fear of falling using Falls Efficacy Scale
Time frame: Baseline
Falls Efficacy Scale (FES-I)
Evaluation of fear of falling using Falls Efficacy Scale
Time frame: Evaluation A', 6- months
Falls Efficacy Scale (FES-I)
Assessment of fear of falling using Falls Efficacy Scale
Time frame: Evaluation B', 3 months after evaluation A'
Activities-specific Balance Confidence (ABC) Scale
Assessment of Balance Confidence using ABC
Time frame: Baseline
Activities-specific Balance Confidence (ABC) Scale
Assessment of Balance Confidence using ABC
Time frame: Evaluation A', 6- months
Activities-specific Balance Confidence (ABC) Scale
Assessment of Balance Confidence using ABC
Time frame: Evaluation B', 3 months after evaluation A'
Minnesota Living with Heart Failure (MLHFQ)
Assessment of health-related quality of life using MLHFQ
Time frame: Baseline
Minnesota Living with Heart Failure (MLHFQ)
Assessment of health-related quality of life using MLHFQ
Time frame: Evaluation A', 6- months
Minnesota Living with Heart Failure (MLHFQ)
Assessment of health-related quality of life using MLHFQ
Time frame: Evaluation B', 3 months after evaluation A'
Pittsburgh Sleep Quality Index (PSQI)
Assessment of Sleep Quality using PSQI
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Assessment of Sleep Quality using PSQI
Time frame: Evaluation A', 6- months
Pittsburgh Sleep Quality Index (PSQI)
Assessment of Sleep Quality using PSQI
Time frame: Evaluation B', 3 months after evaluation A'
Intrinsic Motivation Inventory (IMI)
Assessment of Intrinsic Motivation using IMI
Time frame: Baseline
Intrinsic Motivation Inventory (IMI)
Assessment of Intrinsic Motivation using IMI
Time frame: Evaluation A', 6- months
Intrinsic Motivation Inventory (IMI)
Assessment of Intrinsic Motivation using IMI
Time frame: Evaluation B', 3 months after evaluation A'
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Assessment of Depression and Anxiety using HRSD and HARS
Time frame: Baseline
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Assessment of Depression and Anxiety using HRSD and HARS
Time frame: Evaluation A', 6- months
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Assessment of Depression and Anxiety using HRSD and HARS
Time frame: Evaluation B', 3 months after evaluation A'
Montreal Cognitive Assessment Test (MOCA)
Assessment of cognitive function using MOCA
Time frame: Baseline
Montreal Cognitive Assessment Test (MOCA)
Assessment of cognitive function using MOCA
Time frame: Evaluation A', 6- months
Montreal Cognitive Assessment Test (MOCA)
Assessment of cognitive function using MOCA
Time frame: Evaluation B', 3 months after evaluation A'
Falls
Assessment of the number of weekly falls
Time frame: Baseline
Falls
Assessment of the number of weekly falls
Time frame: Evaluation A', 6- months
Falls
Assessment of the number of weekly falls
Time frame: Evaluation B', 3 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
Time frame: Baseline
Evaluation of Physical Activity and Sleep Quality using a wearable device
Evaluation of Physical Activity and Sleep Quality using a wearable device
Time frame: 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
Time frame: Evaluation B', 3 months after evaluation A'
Foot Preference Questionnaire (FPQ)
Assessment of Foot Preference during static balance or activities using FPQ
Time frame: Baseline
Foot Preference Questionnaire (FPQ)
Assessment of Foot Preference during static balance or activities using FPQ
Time frame: Evaluation A', 6- months
Foot Preference Questionnaire (FPQ)
Assessment of Foot Preference during static balance or activities using FPQ
Time frame: Evaluation B', 3 months after evaluation A'
Fear of Falling and Activity Restriction (SAFE)
Assessement of Fear of Falling and Activity Restriction (SAFE)
Time frame: Baseline
Fear of Falling and Activity Restriction (SAFE)
Assessment of Fear of Falling and Activity Restriction (SAFE)
Time frame: Evaluation A', 6- months
Fear of Falling and Activity Restriction (SAFE)
Assessment of Fear of Falling and Activity Restriction (SAFE)
Time frame: Evaluation B', 3 months after evaluation A'
Trail Making Test
Assessment of visual attention and task switching using Trail Making Test
Time frame: Baseline
Trail Making Test
Assessment of visual attention and task switching using Trail Making Test
Time frame: Evaluation A', 6- months
Trail Making Test
Assessment of visual attention and task switching using Trail Making Test
Time frame: Evaluation B', 3 months after evaluation A'
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