Chronic Heart FailureNCT06036615
The Effect of Exercise Training and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure
A study testing Exercise Intervention in people with Chronic Heart Failure, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Oct 2023to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute Myocardial Infarction (<4 weeks)
- Severe valvular diseases
- Potentially malignant arrhythmias
- Νeurological, or orthopedic limitations/non- ambulant status
- Cognitive disorders
- Poor regulation of comorbidities
Show all 10Show fewer
- Already participating in organized exercise programs
- Current pregnancy
- NYHA function class IV
- Inability/unwillingness to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andriana Teloudi, PhDc contact
Greece1 site, 1 recruiting
- Recruiting
Sports Medicine Laboratory, Aristotle University of Thessaloniki
Thessaloniki, Thermi, 57001
Evangelia Kouidi, Professor, +302310992189, kouidi@phed.auth.gr
About this study
Official title: The Effect of Exercise Training Intervention and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure.
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.
- Conditions
- Chronic Heart Failure
- Being tested
- Exercise Intervention
- Keywords
- Chronic Heart Failure, Cardiac Rehabilitation, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Exercise Group, 6- month combined aerobic, strengthening, mobility- flexibility exercise intervention, 3- month de-training period Receives: Other: Exercise Intervention |
| Group B | No intervention | Control Group, 10- month normal physical activity, without participating in organized sports activities, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Systolic Function
Evaluation of Left Ventricular Ejection Fraction
Measured: Baseline
Left Ventricular Systolic Function
Evaluation of Left Ventricular Ejection Fraction
Measured: Evaluation A', 6- months
Left Ventricular Systolic Function
Evaluation of Left Ventricular Ejection Fraction
Measured: 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
Measured: Baseline
Cardiac Autonomic Nervous System Function
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Measured: Evaluation A', 6- months
Cardiac Autonomic Nervous System Function
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Measured: Evaluation B', 3 months
Body Composition Analysis
Evaluation of Body Composition Analysis
Measured: Baseline
Body Composition Analysis
Evaluation of Body Composition Analysis
Measured: Evaluation A', 3- months
Body Composition Analysis
Evaluation of Body Composition Analysis
Measured: Evaluation B', 3 months after evaluation A'
Six- Minute Walking Test
Estimation of aerobic capacity through six minutes walking test
Measured: Baseline
Six- Minute Walking Test
Estimation of aerobic capacity through six minutes walking test
Measured: Evaluation A', 6- months
Six- Minute Walking Test
Estimation of aerobic capacity through six minutes walking test
Measured: Evaluation B', 3 months after evaluation A'
Timed- Up-and-Go Test
Evaluation of functional capacity using Timed- Up-and-Go Test
Measured: Baseline
Timed- Up-and-Go Test
Evaluation of functional capacity using Timed- Up-and-Go Test
Measured: Evaluation A', 6- months
Timed- Up-and-Go Test
Evaluation of functional capacity and mobility using Timed- Up-and-Go Test
Measured: Evaluation B', 3 months after evaluation A'
4m-Walking Test
Evaluation of functional capacity and mobility using 4m-Walking Test
Measured: Baseline
4m-Walking Test
Evaluation of functional capacity and mobility using 4m-Walking Test
Measured: Evaluation A', 6- months
4m-Walking Test
Evaluation of functional capacity and mobility using 4m-Walking Test
Measured: Evaluation B', 3 months after evaluation A'
30-second Sit-to-Stand (STS)Test
Evaluation of functional capacity and mobility using 30-second STS
Measured: Baseline
30-second Sit-to-Stand (STS)Test
Evaluation of functional capacity and mobility using 30-second STS
Measured: Evaluation A', 6- months
30-second Sit-to-Stand (STS)Test
Evaluation of functional capacity and mobility using 30-second STS
Measured: 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
Measured: Baseline
5 Sit-to-Stand (5-STS)Test
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
Measured: Evaluation A', 6- months
5 Sit-to-Stand (5-STS)Test
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
Measured: Evaluation B', 3 months after evaluation A'
mini-BEST Balance Test
Evaluation of balance using mini-BEST Balance Test
Measured: Baseline
mini-BEST Balance Test
Evaluation of balance using mini-BEST Balance Test
Measured: Evaluation A', 6- months
mini-BEST Balance Test
Evaluation of balance using mini-BEST Balance Test
Measured: Evaluation B', 3 months after evaluation A'
Berg Balance Scale Test
Evaluation of balance using Berg Balance Scale Test
Measured: Baseline
Berg Balance Scale Test
Evaluation of balance using Berg Balance Scale Test
Measured: Evaluation A', 6- months
Berg Balance Scale Test
Evaluation of balance using Berg Balance Scale Test
Measured: Evaluation B', 3 months after evaluation A'
Functional Gait Assessment Test
Evaluation of Functional Gait using Functional Gait Assessement Test
Measured: Baseline
Functional Gait Assessment Test
Evaluation of Functional Gait using Functional Gait Assessement Test
Measured: Evaluation A', 6- months
Functional Gait Assessment Test
Evaluation of Functional Gait using Functional Gait Assessement Test
Measured: 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
Measured: Baseline
Static Balance Test using 3D Balance Force Plate
Evaluation of Static Balance Test using 3D Balance Force Plate
Measured: Evaluation A', 6- months
Static Balance Test using 3D Balance Force Plate
Evaluation of Static Balance Test using 3D Balance Force Plate
Measured: Evaluation B', 3 months after evaluation A'
Handgrip Strength
Evaluation of Handgrip Strength
Measured: Baseline
Handgrip Strength
Evaluation of Handgrip Strength
Measured: Evaluation A', 6- months
Handgrip Strength
Evaluation of Handgrip Strength
Measured: Evaluation B', 3 months after evaluation A'
Strength of Upper and Lower Extremities
Evaluation of Strength of Upper and Lower Extremities
Measured: Baseline
Strength of Upper and Lower Extremities
Evaluation of Strength of Upper and Lower Extremities
Measured: Evaluation A', 6- months
Strength of Upper and Lower Extremities
Evaluation of Strength of Upper and Lower Extremities
Measured: Evaluation B', 3 months after evaluation A'
Isometric Pulling in a Semi-Squat Position
Evaluation of Isometric Pulling in a Semi-Squat Position
Measured: Baseline
Isometric Pulling in a Semi-Squat Position
Evaluation of Isometric Pulling in a Semi-Squat Position
Measured: Evaluation A', 6- months
Isometric Pulling in a Semi-Squat Position
Evaluation of Isometric Pulling in a Semi-Squat Position
Measured: Evaluation B', 3 months after evaluation A'
30- second Arm Curl Test
Evaluation using Arm Curl Test
Measured: Baseline
30- second Arm Curl Test
Evaluation using Arm Curl Test
Measured: Evaluation A', 6- months
30- second Arm Curl Test
Evaluation using Arm Curl Test
Measured: Evaluation B', 3 months after evaluation A'
Sit-and-Reach Test
Evaluation of mobility-flexibility using Sit-and-Reach Test
Measured: Baseline
Sit-and-Reach Test
Evaluation of mobility-flexibility using Sit-and-Reach Test
Measured: Evaluation A', 6- months
Sit-and-Reach Test
Evaluation of mobility-flexibility using Sit-and-Reach Test
Measured: Evaluation B', 3 months after evaluation A'
Back Scratch Test
Evaluation of mobility using Back Scratch Test
Measured: Baseline
Back Scratch Test
Evaluation of mobility using Back Scratch Test
Measured: Evaluation A', 6- months
Back Scratch Test
Evaluation of mobility using Back Scratch Test
Measured: Evaluation B', 3 months after evaluation A'
SF-36
Assessment of Quality of Life using SF-36
Measured: Baseline
SF-36
Assessment of Quality of Life using SF-36
Measured: Evaluation A', 6- months
SF-36
Assessment of Quality of Life using SF-36
Measured: Evaluation B', 3 months after evaluation A'
I-PAQ
Assessment of Physical Activity using I-PAQ
Measured: Baseline
I-PAQ
Assessment of Physical Activity using I-PAQ
Measured: Evaluation A', 6- months
I-PAQ
Assessment of Physical Activity using I-PAQ
Measured: Evaluation B', 3 months after evaluation A'
Beck Depression Inventory
Assessment of Depression using Beck Depression Inventory
Measured: Baseline
Beck Depression Inventory
Assessment of Depression using Beck Depression Inventory
Measured: Evaluation A', 6- months
Beck Depression Inventory
Assessment of Depression using Beck Depression Inventory
Measured: Evaluation B', 3 months after evaluation A'
Falls Efficacy Scale (FES-I)
Assessment of fear of falling using Falls Efficacy Scale
Measured: Baseline
Falls Efficacy Scale (FES-I)
Evaluation of fear of falling using Falls Efficacy Scale
Measured: Evaluation A', 6- months
Falls Efficacy Scale (FES-I)
Assessment of fear of falling using Falls Efficacy Scale
Measured: Evaluation B', 3 months after evaluation A'
Activities-specific Balance Confidence (ABC) Scale
Assessment of Balance Confidence using ABC
Measured: Baseline
Activities-specific Balance Confidence (ABC) Scale
Assessment of Balance Confidence using ABC
Measured: Evaluation A', 6- months
Activities-specific Balance Confidence (ABC) Scale
Assessment of Balance Confidence using ABC
Measured: Evaluation B', 3 months after evaluation A'
Minnesota Living with Heart Failure (MLHFQ)
Assessment of health-related quality of life using MLHFQ
Measured: Baseline
Minnesota Living with Heart Failure (MLHFQ)
Assessment of health-related quality of life using MLHFQ
Measured: Evaluation A', 6- months
Minnesota Living with Heart Failure (MLHFQ)
Assessment of health-related quality of life using MLHFQ
Measured: Evaluation B', 3 months after evaluation A'
Pittsburgh Sleep Quality Index (PSQI)
Assessment of Sleep Quality using PSQI
Measured: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Assessment of Sleep Quality using PSQI
Measured: Evaluation A', 6- months
Pittsburgh Sleep Quality Index (PSQI)
Assessment of Sleep Quality using PSQI
Measured: Evaluation B', 3 months after evaluation A'
Intrinsic Motivation Inventory (IMI)
Assessment of Intrinsic Motivation using IMI
Measured: Baseline
Intrinsic Motivation Inventory (IMI)
Assessment of Intrinsic Motivation using IMI
Measured: Evaluation A', 6- months
Intrinsic Motivation Inventory (IMI)
Assessment of Intrinsic Motivation using IMI
Measured: 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
Measured: Baseline
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Assessment of Depression and Anxiety using HRSD and HARS
Measured: 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
Measured: Evaluation B', 3 months after evaluation A'
Montreal Cognitive Assessment Test (MOCA)
Assessment of cognitive function using MOCA
Measured: Baseline
Montreal Cognitive Assessment Test (MOCA)
Assessment of cognitive function using MOCA
Measured: Evaluation A', 6- months
Montreal Cognitive Assessment Test (MOCA)
Assessment of cognitive function using MOCA
Measured: Evaluation B', 3 months after evaluation A'
Falls
Assessment of the number of weekly falls
Measured: Baseline
Falls
Assessment of the number of weekly falls
Measured: Evaluation A', 6- months
Falls
Assessment of the number of weekly falls
Measured: 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
Measured: Baseline
Evaluation of Physical Activity and Sleep Quality using a wearable device
Evaluation of Physical Activity and Sleep Quality using a wearable device
Measured: 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
Measured: Evaluation B', 3 months after evaluation A'
Foot Preference Questionnaire (FPQ)
Assessment of Foot Preference during static balance or activities using FPQ
Measured: Baseline
Foot Preference Questionnaire (FPQ)
Assessment of Foot Preference during static balance or activities using FPQ
Measured: Evaluation A', 6- months
Foot Preference Questionnaire (FPQ)
Assessment of Foot Preference during static balance or activities using FPQ
Measured: Evaluation B', 3 months after evaluation A'
Fear of Falling and Activity Restriction (SAFE)
Assessement of Fear of Falling and Activity Restriction (SAFE)
Measured: Baseline
Fear of Falling and Activity Restriction (SAFE)
Assessment of Fear of Falling and Activity Restriction (SAFE)
Measured: Evaluation A', 6- months
Fear of Falling and Activity Restriction (SAFE)
Assessment of Fear of Falling and Activity Restriction (SAFE)
Measured: Evaluation B', 3 months after evaluation A'
Trail Making Test
Assessment of visual attention and task switching using Trail Making Test
Measured: Baseline
Trail Making Test
Assessment of visual attention and task switching using Trail Making Test
Measured: Evaluation A', 6- months
Trail Making Test
Assessment of visual attention and task switching using Trail Making Test
Measured: Evaluation B', 3 months after evaluation A'
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Oct 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Kouidi, Aristotle University Of Thessaloniki
- Investigators
- Evangelia Kouidi, Professor, Study chair, Director of Sports Medicine Laboratory, Aristotle University of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036615
- Sponsor's protocol ID
- 110/2022
- Status last verified
- Aug 2025
- First submitted
- 7 Sep 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Training Intervention and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure.
- ClinicalTrials.gov ID
- NCT06036615
- Acronym / sponsor ID
- 110/2022
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic Heart Failure, Cardiac Rehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Exercise InterventionExercise Group, 6- month combined aerobic, strengthening, mobility- flexibility exercise intervention, 3- month de-training period |
| Group B | No intervention | –Control Group, 10- month normal physical activity, without participating in organized sports activities, no intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- Acute Myocardial Infarction (<4 weeks)
- Severe valvular diseases
- Potentially malignant arrhythmias
- Νeurological, or orthopedic limitations/non- ambulant status
- Cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionPatients 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. | Other | Group A |
Primary outcome
Left Ventricular Systolic Function
Time frame: Baseline
Evaluation of Left Ventricular Ejection Fraction
Left Ventricular Systolic Function
Time frame: Evaluation A', 6- months
Evaluation of Left Ventricular Ejection Fraction
Left Ventricular Systolic Function
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of Left Ventricular Ejection Fraction
Cardiac Autonomic Nervous System Function
Time frame: Baseline
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Cardiac Autonomic Nervous System Function
Time frame: Evaluation A', 6- months
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Cardiac Autonomic Nervous System Function
Time frame: Evaluation B', 3 months
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Body Composition Analysis
Time frame: Baseline
Evaluation of Body Composition Analysis
Body Composition Analysis
Time frame: Evaluation A', 3- months
Evaluation of Body Composition Analysis
Body Composition Analysis
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of Body Composition Analysis
Six- Minute Walking Test
Time frame: Baseline
Estimation of aerobic capacity through six minutes walking test
Six- Minute Walking Test
Time frame: Evaluation A', 6- months
Estimation of aerobic capacity through six minutes walking test
Six- Minute Walking Test
Time frame: Evaluation B', 3 months after evaluation A'
Estimation of aerobic capacity through six minutes walking test
Timed- Up-and-Go Test
Time frame: Baseline
Evaluation of functional capacity using Timed- Up-and-Go Test
Timed- Up-and-Go Test
Time frame: Evaluation A', 6- months
Evaluation of functional capacity using Timed- Up-and-Go Test
Timed- Up-and-Go Test
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of functional capacity and mobility using Timed- Up-and-Go Test
4m-Walking Test
Time frame: Baseline
Evaluation of functional capacity and mobility using 4m-Walking Test
4m-Walking Test
Time frame: Evaluation A', 6- months
Evaluation of functional capacity and mobility using 4m-Walking Test
4m-Walking Test
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of functional capacity and mobility using 4m-Walking Test
30-second Sit-to-Stand (STS)Test
Time frame: Baseline
Evaluation of functional capacity and mobility using 30-second STS
30-second Sit-to-Stand (STS)Test
Time frame: Evaluation A', 6- months
Evaluation of functional capacity and mobility using 30-second STS
30-second Sit-to-Stand (STS)Test
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of functional capacity and mobility using 30-second STS
5 Sit-to-Stand (5-STS)Test
Time frame: Baseline
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
5 Sit-to-Stand (5-STS)Test
Time frame: Evaluation A', 6- months
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
5 Sit-to-Stand (5-STS)Test
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
mini-BEST Balance Test
Time frame: Baseline
Evaluation of balance using mini-BEST Balance Test
mini-BEST Balance Test
Time frame: Evaluation A', 6- months
Evaluation of balance using mini-BEST Balance Test
mini-BEST Balance Test
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of balance using mini-BEST Balance Test
Berg Balance Scale Test
Time frame: Baseline
Evaluation of balance using Berg Balance Scale Test
Berg Balance Scale Test
Time frame: Evaluation A', 6- months
Evaluation of balance using Berg Balance Scale Test
Berg Balance Scale Test
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of balance using Berg Balance Scale Test
Functional Gait Assessment Test
Time frame: Baseline
Evaluation of Functional Gait using Functional Gait Assessement Test
Functional Gait Assessment Test
Time frame: Evaluation A', 6- months
Evaluation of Functional Gait using Functional Gait Assessement Test
Functional Gait Assessment Test
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of Functional Gait using Functional Gait Assessement Test
Static Balance Test using 3D Balance Force Plate
Time frame: Baseline
Evaluation of Static Balance Test using 3D Balance Force Plate
Static Balance Test using 3D Balance Force Plate
Time frame: Evaluation A', 6- months
Evaluation of Static Balance Test using 3D Balance Force Plate
Static Balance Test using 3D Balance Force Plate
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of Static Balance Test using 3D Balance Force Plate
Handgrip Strength
Time frame: Baseline
Evaluation of Handgrip Strength
Handgrip Strength
Time frame: Evaluation A', 6- months
Evaluation of Handgrip Strength
Handgrip Strength
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of Handgrip Strength
Strength of Upper and Lower Extremities
Time frame: Baseline
Evaluation of Strength of Upper and Lower Extremities
Strength of Upper and Lower Extremities
Time frame: Evaluation A', 6- months
Evaluation of Strength of Upper and Lower Extremities
Strength of Upper and Lower Extremities
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of Strength of Upper and Lower Extremities
Isometric Pulling in a Semi-Squat Position
Time frame: Baseline
Evaluation of Isometric Pulling in a Semi-Squat Position
Isometric Pulling in a Semi-Squat Position
Time frame: Evaluation A', 6- months
Evaluation of Isometric Pulling in a Semi-Squat Position
Isometric Pulling in a Semi-Squat Position
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of Isometric Pulling in a Semi-Squat Position
30- second Arm Curl Test
Time frame: Baseline
Evaluation using Arm Curl Test
30- second Arm Curl Test
Time frame: Evaluation A', 6- months
Evaluation using Arm Curl Test
30- second Arm Curl Test
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation using Arm Curl Test
Sit-and-Reach Test
Time frame: Baseline
Evaluation of mobility-flexibility using Sit-and-Reach Test
Sit-and-Reach Test
Time frame: Evaluation A', 6- months
Evaluation of mobility-flexibility using Sit-and-Reach Test
Sit-and-Reach Test
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of mobility-flexibility using Sit-and-Reach Test
Back Scratch Test
Time frame: Baseline
Evaluation of mobility using Back Scratch Test
Back Scratch Test
Time frame: Evaluation A', 6- months
Evaluation of mobility using Back Scratch Test
Back Scratch Test
Time frame: Evaluation B', 3 months after evaluation A'
Evaluation of mobility using Back Scratch Test
SF-36
Time frame: Baseline
Assessment of Quality of Life using SF-36
SF-36
Time frame: Evaluation A', 6- months
Assessment of Quality of Life using SF-36
SF-36
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of Quality of Life using SF-36
I-PAQ
Time frame: Baseline
Assessment of Physical Activity using I-PAQ
I-PAQ
Time frame: Evaluation A', 6- months
Assessment of Physical Activity using I-PAQ
I-PAQ
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of Physical Activity using I-PAQ
Beck Depression Inventory
Time frame: Baseline
Assessment of Depression using Beck Depression Inventory
Beck Depression Inventory
Time frame: Evaluation A', 6- months
Assessment of Depression using Beck Depression Inventory
Beck Depression Inventory
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of Depression using Beck Depression Inventory
Falls Efficacy Scale (FES-I)
Time frame: Baseline
Assessment of fear of falling using Falls Efficacy Scale
Falls Efficacy Scale (FES-I)
Time frame: Evaluation A', 6- months
Evaluation of fear of falling using Falls Efficacy Scale
Falls Efficacy Scale (FES-I)
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of fear of falling using Falls Efficacy Scale
Activities-specific Balance Confidence (ABC) Scale
Time frame: Baseline
Assessment of Balance Confidence using ABC
Activities-specific Balance Confidence (ABC) Scale
Time frame: Evaluation A', 6- months
Assessment of Balance Confidence using ABC
Activities-specific Balance Confidence (ABC) Scale
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of Balance Confidence using ABC
Minnesota Living with Heart Failure (MLHFQ)
Time frame: Baseline
Assessment of health-related quality of life using MLHFQ
Minnesota Living with Heart Failure (MLHFQ)
Time frame: Evaluation A', 6- months
Assessment of health-related quality of life using MLHFQ
Minnesota Living with Heart Failure (MLHFQ)
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of health-related quality of life using MLHFQ
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Assessment of Sleep Quality using PSQI
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Evaluation A', 6- months
Assessment of Sleep Quality using PSQI
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of Sleep Quality using PSQI
Intrinsic Motivation Inventory (IMI)
Time frame: Baseline
Assessment of Intrinsic Motivation using IMI
Intrinsic Motivation Inventory (IMI)
Time frame: Evaluation A', 6- months
Assessment of Intrinsic Motivation using IMI
Intrinsic Motivation Inventory (IMI)
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of Intrinsic Motivation using IMI
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Time frame: Baseline
Assessment of Depression and Anxiety using HRSD and HARS
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Time frame: Evaluation A', 6- months
Assessment of Depression and Anxiety using HRSD and HARS
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of Depression and Anxiety using HRSD and HARS
Montreal Cognitive Assessment Test (MOCA)
Time frame: Baseline
Assessment of cognitive function using MOCA
Montreal Cognitive Assessment Test (MOCA)
Time frame: Evaluation A', 6- months
Assessment of cognitive function using MOCA
Montreal Cognitive Assessment Test (MOCA)
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of cognitive function using MOCA
Falls
Time frame: Baseline
Assessment of the number of weekly falls
Falls
Time frame: Evaluation A', 6- months
Assessment of the number of weekly falls
Falls
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of the number of weekly falls
Evaluation of Physical Activity and Sleep Quality using a wearable device
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'
Evaluation of Physical Activity and Sleep Quality using a wearable device
Foot Preference Questionnaire (FPQ)
Time frame: Baseline
Assessment of Foot Preference during static balance or activities using FPQ
Foot Preference Questionnaire (FPQ)
Time frame: Evaluation A', 6- months
Assessment of Foot Preference during static balance or activities using FPQ
Foot Preference Questionnaire (FPQ)
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of Foot Preference during static balance or activities using FPQ
Fear of Falling and Activity Restriction (SAFE)
Time frame: Baseline
Assessement of Fear of Falling and Activity Restriction (SAFE)
Fear of Falling and Activity Restriction (SAFE)
Time frame: Evaluation A', 6- months
Assessment of Fear of Falling and Activity Restriction (SAFE)
Fear of Falling and Activity Restriction (SAFE)
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of Fear of Falling and Activity Restriction (SAFE)
Trail Making Test
Time frame: Baseline
Assessment of visual attention and task switching using Trail Making Test
Trail Making Test
Time frame: Evaluation A', 6- months
Assessment of visual attention and task switching using Trail Making Test
Trail Making Test
Time frame: Evaluation B', 3 months after evaluation A'
Assessment of visual attention and task switching using Trail Making Test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andriana Teloudi, PhDc contact
Evangelia Kouidi, Professor study chair
Director of Sports Medicine Laboratory, Aristotle University of Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Chronic Heart Failure, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evangelia Kouidi, Professor (+302310992189, kouidi@phed.auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Systolic Function (time frame: Baseline). The study lists 99 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.