The Effect of Exercise Training and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure - Trial NCT06036615

Timeline & Enrollment

Primary Outcome

Left Ventricular Systolic Function,Left Ventricular Systolic Function,Left Ventricular Systolic Function,Cardiac Autonomic Nervous System Function,Cardiac Autonomic Nervous System Function,Cardiac Autonomic Nervous System Function,Body Composition Analysis,Body Composition Analysis,Body Composition Analysis,Six- Minute Walking Test,Six- Minute Walking Test,Six- Minute Walking Test,Timed- Up-and-Go Test,Timed- Up-and-Go Test,Timed- Up-and-Go Test,4m-Walking Test,4m-Walking Test,4m-Walking Test,30-second Sit-to-Stand (STS)Test,30-second Sit-to-Stand (STS)Test,30-second Sit-to-Stand (STS)Test,5 Sit-to-Stand (5-STS)Test,5 Sit-to-Stand (5-STS)Test,5 Sit-to-Stand (5-STS)Test,mini-BEST Balance Test,mini-BEST Balance Test,mini-BEST Balance Test,Berg Balance Scale Test,Berg Balance Scale Test,Berg Balance Scale Test,Functional Gait Assessment Test,Functional Gait Assessment Test,Functional Gait Assessment Test,Static Balance Test using 3D Balance Force Plate,Static Balance Test using 3D Balance Force Plate,Static Balance Test using 3D Balance Force Plate,Handgrip Strength,Handgrip Strength,Handgrip Strength,Strength of Upper and Lower Extremities,Strength of Upper and Lower Extremities,Strength of Upper and Lower Extremities,Isometric Pulling in a Semi-Squat Position,Isometric Pulling in a Semi-Squat Position,Isometric Pulling in a Semi-Squat Position,30- second Arm Curl Test,30- second Arm Curl Test,30- second Arm Curl Test,Sit-and-Reach Test,Sit-and-Reach Test,Sit-and-Reach Test,Back Scratch Test,Back Scratch Test,Back Scratch Test,SF-36,SF-36,SF-36,I-PAQ,I-PAQ,I-PAQ,Beck Depression Inventory,Beck Depression Inventory,Beck Depression Inventory,Falls Efficacy Scale (FES-I),Falls Efficacy Scale (FES-I),Falls Efficacy Scale (FES-I),Activities-specific Balance Confidence (ABC) Scale,Activities-specific Balance Confidence (ABC) Scale,Activities-specific Balance Confidence (ABC) Scale,Minnesota Living with Heart Failure (MLHFQ),Minnesota Living with Heart Failure (MLHFQ),Minnesota Living with Heart Failure (MLHFQ),Pittsburgh Sleep Quality Index (PSQI),Pittsburgh Sleep Quality Index (PSQI),Pittsburgh Sleep Quality Index (PSQI),Intrinsic Motivation Inventory (IMI),Intrinsic Motivation Inventory (IMI),Intrinsic Motivation Inventory (IMI),Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS),Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS),Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS),Montreal Cognitive Assessment Test (MOCA),Montreal Cognitive Assessment Test (MOCA),Montreal Cognitive Assessment Test (MOCA),Falls,Falls,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,Foot Preference Questionnaire (FPQ),Foot Preference Questionnaire (FPQ),Foot Preference Questionnaire (FPQ),Fear of Falling and Activity Restriction (SAFE),Fear of Falling and Activity Restriction (SAFE),Fear of Falling and Activity Restriction (SAFE),Trail Making Test,Trail Making Test,Trail Making Test

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.

ICD-10 Classifications