Chronic Heart Failure
Conditions
Keywords
Chronic Heart Failure, Cardiac Rehabilitation, Exercise
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.
Interventions
OTHERExercise 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 3-month de-training period, continuing their normal physical activity.
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Systolic Function | Baseline | Evaluation of Left Ventricular Ejection Fraction |
| Cardiac Autonomic Nervous System Function | Baseline | Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement |
| Body Composition Analysis | Baseline | Evaluation of Body Composition Analysis |
| Six- Minute Walking Test | Baseline | Estimation of aerobic capacity through six minutes walking test |
| Timed- Up-and-Go Test | Baseline | Evaluation of functional capacity using Timed- Up-and-Go Test |
| 4m-Walking Test | Baseline | Evaluation of functional capacity and mobility using 4m-Walking Test |
| 30-second Sit-to-Stand (STS)Test | Baseline | Evaluation of functional capacity and mobility using 30-second STS |
| 5 Sit-to-Stand (5-STS)Test | Baseline | Evaluation of functional capacity and mobility using 5 Sit-to-Stand |
| mini-BEST Balance Test | Baseline | Evaluation of balance using mini-BEST Balance Test |
| Berg Balance Scale Test | Baseline | Evaluation of balance using Berg Balance Scale Test |
| Functional Gait Assessment Test | Baseline | Evaluation of Functional Gait using Functional Gait Assessement Test |
| Static Balance Test using 3D Balance Force Plate | Baseline | Evaluation of Static Balance Test using 3D Balance Force Plate |
| Handgrip Strength | Baseline | Evaluation of Handgrip Strength |
| Strength of Upper and Lower Extremities | Baseline | Evaluation of Strength of Upper and Lower Extremities |
| Isometric Pulling in a Semi-Squat Position | Baseline | Evaluation of Isometric Pulling in a Semi-Squat Position |
| 30- second Arm Curl Test | Baseline | Evaluation using Arm Curl Test |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline | Assessment of Sleep Quality using PSQI |
| Intrinsic Motivation Inventory (IMI) | Baseline | Assessment of Intrinsic Motivation using IMI |
| Sit-and-Reach Test | Baseline | Evaluation of mobility-flexibility using Sit-and-Reach Test |
| Back Scratch Test | Baseline | Evaluation of mobility using Back Scratch Test |
| SF-36 | Baseline | Assessment of Quality of Life using SF-36 |
| I-PAQ | Baseline | Assessment of Physical Activity using I-PAQ |
| Beck Depression Inventory | Baseline | Assessment of Depression using Beck Depression Inventory |
| Falls Efficacy Scale (FES-I) | Baseline | Assessment of fear of falling using Falls Efficacy Scale |
| Activities-specific Balance Confidence (ABC) Scale | Baseline | Assessment of Balance Confidence using ABC |
| Minnesota Living with Heart Failure (MLHFQ) | Baseline | Assessment of health-related quality of life using MLHFQ |
| Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS) | Baseline | Assessment of Depression and Anxiety using HRSD and HARS |
| Montreal Cognitive Assessment Test (MOCA) | Baseline | Assessment of cognitive function using MOCA |
| Falls | Baseline | Assessment of the number of weekly falls |
| Evaluation of Physical Activity and Sleep Quality using a wearable device | Baseline | Evaluation of Physical Activity and Sleep Quality using a wearable device |
| Foot Preference Questionnaire (FPQ) | Baseline | Assessment of Foot Preference during static balance or activities using FPQ |
| Fear of Falling and Activity Restriction (SAFE) | Baseline | Assessement of Fear of Falling and Activity Restriction (SAFE) |
| Trail Making Test | Baseline | Assessment of visual attention and task switching using Trail Making Test |
Countries
Greece
Contacts
Primary ContactEvangelia Kouidi, Professor
Backup ContactAndriana Teloudi, PhDc
Outcome results
None listed