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

Not Applicable

Recruiting

• Conditions: Chronic Heart Failure

• Registration Number: NCT06036615
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Study Start: 2023-10-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-23
• Last Update Posted: 2024-06-25
• Primary Completion: 2025-01-31
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sports Medicine Laboratory, Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Thermi, Greece