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

NCT06036615 | Recruiting

• 1 other identifier: 110/2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure

Keywords

Chronic Heart Failure; Cardiac Rehabilitation; Exercise

Outcome Measures

Primary Outcomes (99)

• 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', 3 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', 3 months

• Body Composition Analysis

  Evaluation of Body Composition Analysis

  Baseline

• Body Composition Analysis

  Evaluation of Body Composition Analysis

  Evaluation A', 3- months

• Body Composition Analysis

  Evaluation of Body Composition Analysis

  Evaluation B', 3 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', 3 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', 3 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', 3 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', 3 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', 3 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', 3 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', 3 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', 3 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', 3 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', 3 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', 3 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', 3 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', 3 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', 3 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', 3 months after evaluation A'

• SF-36

  Assessment of Quality of Life using SF-36

  Baseline

• SF-36

  Assessment of Quality of Life using SF-36

  Evaluation A', 6- months

• SF-36

  Assessment of Quality of Life using SF-36

  Evaluation B', 3 months after evaluation A'

• I-PAQ

  Assessment of Physical Activity using I-PAQ

  Baseline

• I-PAQ

  Assessment of Physical Activity using I-PAQ

  Evaluation A', 6- months

• I-PAQ

  Assessment of Physical Activity using I-PAQ

  Evaluation B', 3 months after evaluation A'

• Beck Depression Inventory

  Assessment of Depression using Beck Depression Inventory

  Baseline

• Beck Depression Inventory

  Assessment of Depression using Beck Depression Inventory

  Evaluation A', 6- months

• Beck Depression Inventory

  Assessment of Depression using Beck Depression Inventory

  Evaluation B', 3 months after evaluation A'

• Falls Efficacy Scale (FES-I)

  Assessment 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)

  Assessment of fear of falling using Falls Efficacy Scale

  Evaluation B', 3 months after evaluation A'

• Activities-specific Balance Confidence (ABC) Scale

  Assessment of Balance Confidence using ABC

  Baseline

• Activities-specific Balance Confidence (ABC) Scale

  Assessment of Balance Confidence using ABC

  Evaluation A', 6- months

• Activities-specific Balance Confidence (ABC) Scale

  Assessment of Balance Confidence using ABC

  Evaluation B', 3 months after evaluation A'

• Minnesota Living with Heart Failure (MLHFQ)

  Assessment of health-related quality of life using MLHFQ

  Baseline

• Minnesota Living with Heart Failure (MLHFQ)

  Assessment of health-related quality of life using MLHFQ

  Evaluation A', 6- months

• Minnesota Living with Heart Failure (MLHFQ)

  Assessment of health-related quality of life using MLHFQ

  Evaluation B', 3 months after evaluation A'

• Pittsburgh Sleep Quality Index (PSQI)

  Assessment of Sleep Quality using PSQI

  Baseline

• Pittsburgh Sleep Quality Index (PSQI)

  Assessment of Sleep Quality using PSQI

  Evaluation A', 6- months

• Pittsburgh Sleep Quality Index (PSQI)

  Assessment of Sleep Quality using PSQI

  Evaluation B', 3 months after evaluation A'

• Intrinsic Motivation Inventory (IMI)

  Assessment of Intrinsic Motivation using IMI

  Baseline

• Intrinsic Motivation Inventory (IMI)

  Assessment of Intrinsic Motivation using IMI

  Evaluation A', 6- months

• Intrinsic Motivation Inventory (IMI)

  Assessment of Intrinsic Motivation using IMI

  Evaluation B', 3 months after evaluation A'

• Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)

  Assessment of Depression and Anxiety using HRSD and HARS

  Baseline

• Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)

  Assessment of Depression and Anxiety using HRSD and HARS

  Evaluation A', 6- months

• Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)

  Assessment of Depression and Anxiety using HRSD and HARS

  Evaluation B', 3 months after evaluation A'

• Montreal Cognitive Assessment Test (MOCA)

  Assessment of cognitive function using MOCA

  Baseline

• Montreal Cognitive Assessment Test (MOCA)

  Assessment of cognitive function using MOCA

  Evaluation A', 6- months

• Montreal Cognitive Assessment Test (MOCA)

  Assessment of cognitive function using MOCA

  Evaluation B', 3 months after evaluation A'

• Falls

  Assessment of the number of weekly falls

  Baseline

• Falls

  Assessment of the number of weekly falls

  Evaluation A', 6- months

• Falls

  Assessment of the number of weekly falls

  Evaluation B', 3 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', 3 months after evaluation A'

• Foot Preference Questionnaire (FPQ)

  Assessment of Foot Preference during static balance or activities using FPQ

  Baseline

• Foot Preference Questionnaire (FPQ)

  Assessment of Foot Preference during static balance or activities using FPQ

  Evaluation A', 6- months

• Foot Preference Questionnaire (FPQ)

  Assessment of Foot Preference during static balance or activities using FPQ

  Evaluation B', 3 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)

  Assessment of Fear of Falling and Activity Restriction (SAFE)

  Evaluation A', 6- months

• Fear of Falling and Activity Restriction (SAFE)

  Assessment of Fear of Falling and Activity Restriction (SAFE)

  Evaluation B', 3 months after evaluation A'

• Trail Making Test

  Assessment of visual attention and task switching using Trail Making Test

  Baseline

• Trail Making Test

  Assessment of visual attention and task switching using Trail Making Test

  Evaluation A', 6- months

• Trail Making Test

  Assessment of visual attention and task switching using Trail Making Test

  Evaluation B', 3 months after evaluation A'

Study Arms (2)

Group A

EXPERIMENTAL

Exercise Group, 6- month combined aerobic, strengthening, mobility- flexibility exercise intervention, 3- month de-training period

Other: Exercise Intervention

Group B

NO INTERVENTION

Control Group, 10- month normal physical activity, without participating in organized sports activities, no intervention

Interventions

Exercise Intervention OTHER

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.

Group A

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Sports Medicine Laboratory, Aristotle University of Thessaloniki

Thessaloniki, Thermi, 57001, Greece

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Evangelia Kouidi, Professor

  Director of Sports Medicine Laboratory, Aristotle University of Thessaloniki, Greece

  STUDY CHAIR

Central Study Contacts

Evangelia Kouidi, Professor

CONTACT

+302310992189; kouidi@phed.auth.gr

Andriana Teloudi, PhDc

CONTACT

teloudia@phed.auth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Sports Medicine

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: October 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 15, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

GR (1)