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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Other: Exercise Intervention

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evangelia Kouidi, Professor; Phone Number: +302310992189; Email: kouidi@phed.auth.gr
• Study Contact Backup: Name: Andriana Teloudi, PhDc; Email: teloudia@phed.auth.gr

Study Locations

• Greece
  • Thermi
    • Thessaloniki, Thermi, Greece, 57001
      • Recruiting
      • Sports Medicine Laboratory, Aristotle University of Thessaloniki
      • Contact: Evangelia Kouidi, Professor; Phone Number: +302310992189; Email: kouidi@phed.auth.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group B; Control Group, 10- month normal physical activity, without participating in organized sports activities, no intervention
Experimental: Group A; Exercise Group, 6- month combined aerobic, strengthening, mobility- flexibility exercise intervention, 4- month de-training period	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Ventricular Systolic Function	Evaluation of Left Ventricular Ejection Fraction	Baseline
Left Ventricular Systolic Function	Evaluation of Left Ventricular Ejection Fraction	Evaluation A', 6- months
Left Ventricular Systolic Function	Evaluation of Left Ventricular Ejection Fraction	Evaluation B', 4 months after evaluation A'
Cardiac Autonomic Nervous System Function	Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement	Baseline
Cardiac Autonomic Nervous System Function	Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement	Evaluation A', 6- months
Cardiac Autonomic Nervous System Function	Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement	Evaluation B', 4 months
Body Composition Analysis	Evaluation of Body Composition Analysis	Baseline
Body Composition Analysis	Evaluation of Body Composition Analysis	Evaluation A', 6- months
Body Composition Analysis	Evaluation of Body Composition Analysis	Evaluation B', 4 months after evaluation A'
Six- Minute Walking Test	Estimation of aerobic capacity through six minutes walking test	Baseline
Six- Minute Walking Test	Estimation of aerobic capacity through six minutes walking test	Evaluation A', 6- months
Six- Minute Walking Test	Estimation of aerobic capacity through six minutes walking test	Evaluation B', 4 months after evaluation A'
Timed- Up-and-Go Test	Evaluation of functional capacity using Timed- Up-and-Go Test	Baseline
Timed- Up-and-Go Test	Evaluation of functional capacity using Timed- Up-and-Go Test	Evaluation A', 6- months
Timed- Up-and-Go Test	Evaluation of functional capacity and mobility using Timed- Up-and-Go Test	Evaluation B', 4 months after evaluation A'
Handgrip Strength	Evaluation of Handgrip Strength	Baseline
Handgrip Strength	Evaluation of Handgrip Strength	Evaluation A', 6- months
Handgrip Strength	Evaluation of Handgrip Strength	Evaluation B', 4 months after evaluation A'
Isometric Pulling in a Semi-Squat Position	Evaluation of Isometric Pulling in a Semi-Squat Position	Baseline
Isometric Pulling in a Semi-Squat Position	Evaluation of Isometric Pulling in a Semi-Squat Position	Evaluation A', 6- months
Isometric Pulling in a Semi-Squat Position	Evaluation of Isometric Pulling in a Semi-Squat Position	Evaluation B', 4 months after evaluation A'
30- second Arm Curl Test	Evaluation using Arm Curl Test	Baseline
30- second Arm Curl Test	Evaluation using Arm Curl Test	Evaluation A', 6- months
30- second Arm Curl Test	Evaluation using Arm Curl Test	Evaluation B', 4 months after evaluation A'
Sit-and-Reach Test	Evaluation of mobility-flexibility using Sit-and-Reach Test	Baseline
Sit-and-Reach Test	Evaluation of mobility-flexibility using Sit-and-Reach Test	Evaluation A', 6- months
Sit-and-Reach Test	Evaluation of mobility-flexibility using Sit-and-Reach Test	Evaluation B', 4 months after evaluation A'
Back Scratch Test	Evaluation of mobility using Back Scratch Test	Baseline
Back Scratch Test	Evaluation of mobility using Back Scratch Test	Evaluation A', 6- months
Back Scratch Test	Evaluation of mobility using Back Scratch Test	Evaluation B', 4 months after evaluation A'
SF-36	Assessement of Quality of Life using SF-36	Baseline
SF-36	Assessement of Quality of Life using SF-36	Evaluation A', 6- months
SF-36	Assessement of Quality of Life using SF-36	Evaluation B', 4 months after evaluation A'
I-PAQ	Assessement of Physical Activity using I-PAQ	Baseline
I-PAQ	Assessement of Physical Activity using I-PAQ	Evaluation A', 6- months
I-PAQ	Assessement of Physical Activity using I-PAQ	Evaluation B', 4 months after evaluation A'
Beck Depression Inventory	Assessement of Depression using Beck Depression Inventory	Baseline
Beck Depression Inventory	Assessement of Depression using Beck Depression Inventory	Evaluation A', 6- months
Beck Depression Inventory	Assessement of Depression using Beck Depression Inventory	Evaluation B', 4 months after evaluation A'
Falls Efficacy Scale (FES-I)	Assessement of fear of falling using Falls Efficacy Scale	Baseline
Falls Efficacy Scale (FES-I)	Evaluation of fear of falling using Falls Efficacy Scale	Evaluation A', 6- months
Falls Efficacy Scale (FES-I)	Assessement of fear of falling using Falls Efficacy Scale	Evaluation B', 4 months after evaluation A'
Activities-specific Balance Confidence (ABC) Scale	Assessement of Balance Confidence using ABC	Baseline
Activities-specific Balance Confidence (ABC) Scale	Assessement of Balance Confidence using ABC	Evaluation A', 6- months
Activities-specific Balance Confidence (ABC) Scale	Assessement of Balance Confidence using ABC	Evaluation B', 4 months after evaluation A'
Pittsburgh Sleep Quality Index (PSQI)	Assessement of Sleep Quality using PSQI	Baseline
Pittsburgh Sleep Quality Index (PSQI)	Assessement of Sleep Quality using PSQI	Evaluation A', 6- months
Pittsburgh Sleep Quality Index (PSQI)	Assessement of Sleep Quality using PSQI	Evaluation B', 4 months after evaluation A'
Intrinsic Motivation Inventory (IMI)	Assessement of Intrinsic Motivation using IMI	Baseline
Intrinsic Motivation Inventory (IMI)	Assessement of Intrinsic Motivation using IMI	Evaluation A', 6- months
Intrinsic Motivation Inventory (IMI)	Assessement of Intrinsic Motivation using IMI	Evaluation B', 4 months after evaluation A'
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)	Assessement of Depression and Anxiety using HRSD and HARS	Baseline
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
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'
Montreal Cognitive Assessment Test (MOCA)	Assessement of cognitive function using MOCA	Baseline
Montreal Cognitive Assessment Test (MOCA)	Assessement of cognitive function using MOCA	Evaluation A', 6- months
Montreal Cognitive Assessment Test (MOCA)	Assessement of cognitive function using MOCA	Evaluation B', 4 months after evaluation A'
Falls	Assessement of the number of weekly falls	Baseline
Falls	Assessement of the number of weekly falls	Evaluation A', 6- months
Falls	Assessement of the number of weekly falls	Evaluation B', 4 months after evaluation A'
Evaluation of Physical Activity and Sleep Quality using a wearable device	Evaluation of Physical Activity and Sleep Quality using a wearable device	Baseline
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
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'
4m-Walking Test	Evaluation of functional capacity and mobility using 4m-Walking Test	Baseline
4m-Walking Test	Evaluation of functional capacity and mobility using 4m-Walking Test	Evaluation A', 6- months
4m-Walking Test	Evaluation of functional capacity and mobility using 4m-Walking Test	Evaluation B', 4 months after evaluation A'
30-second Sit-to-Stand (STS)Test	Evaluation of functional capacity and mobility using 30-second STS	Baseline
30-second Sit-to-Stand (STS)Test	Evaluation of functional capacity and mobility using 30-second STS	Evaluation A', 6- months
30-second Sit-to-Stand (STS)Test	Evaluation of functional capacity and mobility using 30-second STS	Evaluation B', 4 months after evaluation A'
5 Sit-to-Stand (5-STS)Test	Evaluation of functional capacity and mobility using 5 Sit-to-Stand	Baseline
5 Sit-to-Stand (5-STS)Test	Evaluation of functional capacity and mobility using 5 Sit-to-Stand	Evaluation A', 6- months
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'
mini-BEST Balance Test	Evaluation of balance using mini-BEST Balance Test	Baseline
mini-BEST Balance Test	Evaluation of balance using mini-BEST Balance Test	Evaluation A', 6- months
mini-BEST Balance Test	Evaluation of balance using mini-BEST Balance Test	Evaluation B', 4 months after evaluation A'
Berg Balance Scale Test	Evaluation of balance using Berg Balance Scale Test	Baseline
Berg Balance Scale Test	Evaluation of balance using Berg Balance Scale Test	Evaluation A', 6- months
Berg Balance Scale Test	Evaluation of balance using Berg Balance Scale Test	Evaluation B', 4 months after evaluation A'
Functional Gait Assessment Test	Evaluation of Functional Gait using Functional Gait Assessement Test	Baseline
Functional Gait Assessment Test	Evaluation of Functional Gait using Functional Gait Assessement Test	Evaluation A', 6- months
Functional Gait Assessment Test	Evaluation of Functional Gait using Functional Gait Assessement Test	Evaluation B', 4 months after evaluation A'
Static Balance Test using 3D Balance Force Plate	Evaluation of Static Balance Test using 3D Balance Force Plate	Baseline
Static Balance Test using 3D Balance Force Plate	Evaluation of Static Balance Test using 3D Balance Force Plate	Evaluation A', 6- months
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'
Strength of Upper and Lower Extremities	Evaluation of Strength of Upper and Lower Extremities	Baseline
Strength of Upper and Lower Extremities	Evaluation of Strength of Upper and Lower Extremities	Evaluation A', 6- months
Strength of Upper and Lower Extremities	Evaluation of Strength of Upper and Lower Extremities	Evaluation B', 4 months after evaluation A'
Minnesota Living with Heart Failure (MLHFQ)	Assessement of health-related quality of life using MLHFQ	Baseline
Minnesota Living with Heart Failure (MLHFQ)	Assessement of health-related quality of life using MLHFQ	Evaluation A', 6- months
Minnesota Living with Heart Failure (MLHFQ)	Assessement of health-related quality of life using MLHFQ	Evaluation B', 4 months after evaluation A'
Foot Preference Questionnaire (FPQ)	Assessement of Foot Preference during static balance or activities using FPQ	Baseline
Foot Preference Questionnaire (FPQ)	Assessement of Foot Preference during static balance or activities using FPQ	Evaluation A', 6- months
Foot Preference Questionnaire (FPQ)	Assessement of Foot Preference during static balance or activities using FPQ	Evaluation B', 4 months after evaluation A'
Fear of Falling and Activity Restriction (SAFE)	Assessement of Fear of Falling and Activity Restriction (SAFE)	Baseline
Fear of Falling and Activity Restriction (SAFE)	Assessement of Fear of Falling and Activity Restriction (SAFE)	Evaluation A', 6- months
Fear of Falling and Activity Restriction (SAFE)	Assessement of Fear of Falling and Activity Restriction (SAFE)	Evaluation B', 4 months after evaluation A'
Trail Making Test	Assessement of visual attention and task switching using Trail Making Test	Baseline
Trail Making Test	Assessement of visual attention and task switching using Trail Making Test	Evaluation A', 6- months
Trail Making Test	Assessement of visual attention and task switching using Trail Making Test	Evaluation B', 4 months after evaluation A'

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Chronic Heart Failure; Cardiac Rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Heart Failure; Frailty
• Other Study ID Numbers: 110/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No