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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06036615
Other study ID # 110/2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date March 15, 2025

Study information

Verified date October 2023
Source Aristotle University Of Thessaloniki
Contact Evangelia Kouidi, Professor
Phone +302310992189
Email kouidi@phed.auth.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 15, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Age > 18 yrs. of either gender - Confirmed diagnosis (by echocardiography) of HF reduced or preserved left ventricular ejection fraction (HFrEF/?FpEF) - Symptomatic New York Heart Association (NYHA) class II-III Exclusion Criteria: - Acute Myocardial Infarction (<4 weeks) - Severe valvular diseases - Potentially malignant arrhythmias - ?eurological, 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise Intervention
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.

Locations

Country Name City State
Greece Sports Medicine Laboratory, Aristotle University of Thessaloniki Thessaloniki Thermi

Sponsors (1)

Lead Sponsor Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

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