Clinical trial NCT06036615: 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
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure
Cardiac Rehabilitation
Exercise
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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

Primary outcomes:
measure: Left Ventricular Systolic Function
timeFrame: Baseline
measure: Left Ventricular Systolic Function
timeFrame: Evaluation A', 6- months
measure: Left Ventricular Systolic Function
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Cardiac Autonomic Nervous System Function
timeFrame: Baseline
measure: Cardiac Autonomic Nervous System Function
timeFrame: Evaluation A', 6- months
measure: Cardiac Autonomic Nervous System Function
timeFrame: Evaluation B', 3 months
measure: Body Composition Analysis
timeFrame: Baseline
measure: Body Composition Analysis
timeFrame: Evaluation A', 3- months
measure: Body Composition Analysis
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Six- Minute Walking Test
timeFrame: Baseline
measure: Six- Minute Walking Test
timeFrame: Evaluation A', 6- months
measure: Six- Minute Walking Test
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Timed- Up-and-Go Test
timeFrame: Baseline
measure: Timed- Up-and-Go Test
timeFrame: Evaluation A', 6- months
measure: Timed- Up-and-Go Test
timeFrame: Evaluation B', 3 months after evaluation A'
measure: 4m-Walking Test
timeFrame: Baseline
measure: 4m-Walking Test
timeFrame: Evaluation A', 6- months
measure: 4m-Walking Test
timeFrame: Evaluation B', 3 months after evaluation A'
measure: 30-second Sit-to-Stand (STS)Test
timeFrame: Baseline
measure: 30-second Sit-to-Stand (STS)Test
timeFrame: Evaluation A', 6- months
measure: 30-second Sit-to-Stand (STS)Test
timeFrame: Evaluation B', 3 months after evaluation A'
measure: 5 Sit-to-Stand (5-STS)Test
timeFrame: Baseline
measure: 5 Sit-to-Stand (5-STS)Test
timeFrame: Evaluation A', 6- months
measure: 5 Sit-to-Stand (5-STS)Test
timeFrame: Evaluation B', 3 months after evaluation A'
measure: mini-BEST Balance Test
timeFrame: Baseline
measure: mini-BEST Balance Test
timeFrame: Evaluation A', 6- months
measure: mini-BEST Balance Test
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Berg Balance Scale Test
timeFrame: Baseline
measure: Berg Balance Scale Test
timeFrame: Evaluation A', 6- months
measure: Berg Balance Scale Test
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Functional Gait Assessment Test
timeFrame: Baseline
measure: Functional Gait Assessment Test
timeFrame: Evaluation A', 6- months
measure: Functional Gait Assessment Test
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Static Balance Test using 3D Balance Force Plate
timeFrame: Baseline
measure: Static Balance Test using 3D Balance Force Plate
timeFrame: Evaluation A', 6- months
measure: Static Balance Test using 3D Balance Force Plate
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Handgrip Strength
timeFrame: Baseline
measure: Handgrip Strength
timeFrame: Evaluation A', 6- months
measure: Handgrip Strength
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Strength of Upper and Lower Extremities
timeFrame: Baseline
measure: Strength of Upper and Lower Extremities
timeFrame: Evaluation A', 6- months
measure: Strength of Upper and Lower Extremities
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Isometric Pulling in a Semi-Squat Position
timeFrame: Baseline
measure: Isometric Pulling in a Semi-Squat Position
timeFrame: Evaluation A', 6- months
measure: Isometric Pulling in a Semi-Squat Position
timeFrame: Evaluation B', 3 months after evaluation A'
measure: 30- second Arm Curl Test
timeFrame: Baseline
measure: 30- second Arm Curl Test
timeFrame: Evaluation A', 6- months
measure: 30- second Arm Curl Test
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Sit-and-Reach Test
timeFrame: Baseline
measure: Sit-and-Reach Test
timeFrame: Evaluation A', 6- months
measure: Sit-and-Reach Test
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Back Scratch Test
timeFrame: Baseline
measure: Back Scratch Test
timeFrame: Evaluation A', 6- months
measure: Back Scratch Test
timeFrame: Evaluation B', 3 months after evaluation A'
measure: SF-36
timeFrame: Baseline
measure: SF-36
timeFrame: Evaluation A', 6- months
measure: SF-36
timeFrame: Evaluation B', 3 months after evaluation A'
measure: I-PAQ
timeFrame: Baseline
measure: I-PAQ
timeFrame: Evaluation A', 6- months
measure: I-PAQ
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: Evaluation A', 6- months
measure: Beck Depression Inventory
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Falls Efficacy Scale (FES-I)
timeFrame: Baseline
measure: Falls Efficacy Scale (FES-I)
timeFrame: Evaluation A', 6- months
measure: Falls Efficacy Scale (FES-I)
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Activities-specific Balance Confidence (ABC) Scale
timeFrame: Baseline
measure: Activities-specific Balance Confidence (ABC) Scale
timeFrame: Evaluation A', 6- months
measure: Activities-specific Balance Confidence (ABC) Scale
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Minnesota Living with Heart Failure (MLHFQ)
timeFrame: Baseline
measure: Minnesota Living with Heart Failure (MLHFQ)
timeFrame: Evaluation A', 6- months
measure: Minnesota Living with Heart Failure (MLHFQ)
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Evaluation A', 6- months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Intrinsic Motivation Inventory (IMI)
timeFrame: Baseline
measure: Intrinsic Motivation Inventory (IMI)
timeFrame: Evaluation A', 6- months
measure: Intrinsic Motivation Inventory (IMI)
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
timeFrame: Baseline
measure: Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
timeFrame: Evaluation A', 6- months
measure: Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Montreal Cognitive Assessment Test (MOCA)
timeFrame: Baseline
measure: Montreal Cognitive Assessment Test (MOCA)
timeFrame: Evaluation A', 6- months
measure: Montreal Cognitive Assessment Test (MOCA)
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Falls
timeFrame: Baseline
measure: Falls
timeFrame: Evaluation A', 6- months
measure: Falls
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Evaluation of Physical Activity and Sleep Quality using a wearable device
timeFrame: Baseline
measure: Evaluation of Physical Activity and Sleep Quality using a wearable device
timeFrame: Evaluation A', 6- months
measure: Evaluation of Physical Activity and Sleep Quality using a wearable device
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Foot Preference Questionnaire (FPQ)
timeFrame: Baseline
measure: Foot Preference Questionnaire (FPQ)
timeFrame: Evaluation A', 6- months
measure: Foot Preference Questionnaire (FPQ)
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Fear of Falling and Activity Restriction (SAFE)
timeFrame: Baseline
measure: Fear of Falling and Activity Restriction (SAFE)
timeFrame: Evaluation A', 6- months
measure: Fear of Falling and Activity Restriction (SAFE)
timeFrame: Evaluation B', 3 months after evaluation A'
measure: Trail Making Test
timeFrame: Baseline
measure: Trail Making Test
timeFrame: Evaluation A', 6- months
measure: Trail Making Test
timeFrame: Evaluation B', 3 months after evaluation A'
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Sports Medicine Laboratory, Aristotle University of Thessaloniki
state: Thermi
Study officials:
affiliation: Director of Sports Medicine Laboratory, Aristotle University of Thessaloniki, Greece
name: Evangelia Kouidi, Professor
role: STUDY_CHAIR
References: