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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036615
• Other study ID #: 110/2022
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Frailty
• Heart Failure

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'