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NCT Number: NCT06036615

The Effect of Exercise Training 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 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.

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Key information

Conditions

Chronic Heart Failure Behavior Motor Activity

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sports Medicine Laboratory, Aristotle University of Thessaloniki

Thessaloniki, Thermi, 57001, Greece

Location status: Recruiting

Location contact

Evangelia Kouidi, Professor

CONTACT

[email protected]

+302310992189

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Left Ventricular Systolic Function

    Time frame: Baseline

    Evaluation of Left Ventricular Ejection Fraction

  2. Left Ventricular Systolic Function

    Time frame: Evaluation A', 6- months

    Evaluation of Left Ventricular Ejection Fraction

  3. Left Ventricular Systolic Function

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of Left Ventricular Ejection Fraction

  4. Cardiac Autonomic Nervous System Function

    Time frame: Baseline

    Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement

  5. Cardiac Autonomic Nervous System Function

    Time frame: Evaluation A', 6- months

    Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement

  6. Cardiac Autonomic Nervous System Function

    Time frame: Evaluation B', 3 months

    Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement

  7. Body Composition Analysis

    Time frame: Baseline

    Evaluation of Body Composition Analysis

  8. Body Composition Analysis

    Time frame: Evaluation A', 3- months

    Evaluation of Body Composition Analysis

  9. Body Composition Analysis

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of Body Composition Analysis

  10. Six- Minute Walking Test

    Time frame: Baseline

    Estimation of aerobic capacity through six minutes walking test

  11. Six- Minute Walking Test

    Time frame: Evaluation A', 6- months

    Estimation of aerobic capacity through six minutes walking test

  12. Six- Minute Walking Test

    Time frame: Evaluation B', 3 months after evaluation A'

    Estimation of aerobic capacity through six minutes walking test

  13. Timed- Up-and-Go Test

    Time frame: Baseline

    Evaluation of functional capacity using Timed- Up-and-Go Test

  14. Timed- Up-and-Go Test

    Time frame: Evaluation A', 6- months

    Evaluation of functional capacity using Timed- Up-and-Go Test

  15. Timed- Up-and-Go Test

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of functional capacity and mobility using Timed- Up-and-Go Test

  16. 4m-Walking Test

    Time frame: Baseline

    Evaluation of functional capacity and mobility using 4m-Walking Test

  17. 4m-Walking Test

    Time frame: Evaluation A', 6- months

    Evaluation of functional capacity and mobility using 4m-Walking Test

  18. 4m-Walking Test

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of functional capacity and mobility using 4m-Walking Test

  19. 30-second Sit-to-Stand (STS)Test

    Time frame: Baseline

    Evaluation of functional capacity and mobility using 30-second STS

  20. 30-second Sit-to-Stand (STS)Test

    Time frame: Evaluation A', 6- months

    Evaluation of functional capacity and mobility using 30-second STS

  21. 30-second Sit-to-Stand (STS)Test

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of functional capacity and mobility using 30-second STS

  22. 5 Sit-to-Stand (5-STS)Test

    Time frame: Baseline

    Evaluation of functional capacity and mobility using 5 Sit-to-Stand

  23. 5 Sit-to-Stand (5-STS)Test

    Time frame: Evaluation A', 6- months

    Evaluation of functional capacity and mobility using 5 Sit-to-Stand

  24. 5 Sit-to-Stand (5-STS)Test

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of functional capacity and mobility using 5 Sit-to-Stand

  25. mini-BEST Balance Test

    Time frame: Baseline

    Evaluation of balance using mini-BEST Balance Test

  26. mini-BEST Balance Test

    Time frame: Evaluation A', 6- months

    Evaluation of balance using mini-BEST Balance Test

  27. mini-BEST Balance Test

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of balance using mini-BEST Balance Test

  28. Berg Balance Scale Test

    Time frame: Baseline

    Evaluation of balance using Berg Balance Scale Test

  29. Berg Balance Scale Test

    Time frame: Evaluation A', 6- months

    Evaluation of balance using Berg Balance Scale Test

  30. Berg Balance Scale Test

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of balance using Berg Balance Scale Test

  31. Functional Gait Assessment Test

    Time frame: Baseline

    Evaluation of Functional Gait using Functional Gait Assessement Test

  32. Functional Gait Assessment Test

    Time frame: Evaluation A', 6- months

    Evaluation of Functional Gait using Functional Gait Assessement Test

  33. Functional Gait Assessment Test

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of Functional Gait using Functional Gait Assessement Test

  34. Static Balance Test using 3D Balance Force Plate

    Time frame: Baseline

    Evaluation of Static Balance Test using 3D Balance Force Plate

  35. Static Balance Test using 3D Balance Force Plate

    Time frame: Evaluation A', 6- months

    Evaluation of Static Balance Test using 3D Balance Force Plate

  36. Static Balance Test using 3D Balance Force Plate

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of Static Balance Test using 3D Balance Force Plate

  37. Handgrip Strength

    Time frame: Baseline

    Evaluation of Handgrip Strength

  38. Handgrip Strength

    Time frame: Evaluation A', 6- months

    Evaluation of Handgrip Strength

  39. Handgrip Strength

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of Handgrip Strength

  40. Strength of Upper and Lower Extremities

    Time frame: Baseline

    Evaluation of Strength of Upper and Lower Extremities

  41. Strength of Upper and Lower Extremities

    Time frame: Evaluation A', 6- months

    Evaluation of Strength of Upper and Lower Extremities

  42. Strength of Upper and Lower Extremities

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of Strength of Upper and Lower Extremities

  43. Isometric Pulling in a Semi-Squat Position

    Time frame: Baseline

    Evaluation of Isometric Pulling in a Semi-Squat Position

  44. Isometric Pulling in a Semi-Squat Position

    Time frame: Evaluation A', 6- months

    Evaluation of Isometric Pulling in a Semi-Squat Position

  45. Isometric Pulling in a Semi-Squat Position

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of Isometric Pulling in a Semi-Squat Position

  46. 30- second Arm Curl Test

    Time frame: Baseline

    Evaluation using Arm Curl Test

  47. 30- second Arm Curl Test

    Time frame: Evaluation A', 6- months

    Evaluation using Arm Curl Test

  48. 30- second Arm Curl Test

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation using Arm Curl Test

  49. Sit-and-Reach Test

    Time frame: Baseline

    Evaluation of mobility-flexibility using Sit-and-Reach Test

  50. Sit-and-Reach Test

    Time frame: Evaluation A', 6- months

    Evaluation of mobility-flexibility using Sit-and-Reach Test

  51. Sit-and-Reach Test

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of mobility-flexibility using Sit-and-Reach Test

  52. Back Scratch Test

    Time frame: Baseline

    Evaluation of mobility using Back Scratch Test

  53. Back Scratch Test

    Time frame: Evaluation A', 6- months

    Evaluation of mobility using Back Scratch Test

  54. Back Scratch Test

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of mobility using Back Scratch Test

  55. SF-36

    Time frame: Baseline

    Assessment of Quality of Life using SF-36

  56. SF-36

    Time frame: Evaluation A', 6- months

    Assessment of Quality of Life using SF-36

  57. SF-36

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of Quality of Life using SF-36

  58. I-PAQ

    Time frame: Baseline

    Assessment of Physical Activity using I-PAQ

  59. I-PAQ

    Time frame: Evaluation A', 6- months

    Assessment of Physical Activity using I-PAQ

  60. I-PAQ

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of Physical Activity using I-PAQ

  61. Beck Depression Inventory

    Time frame: Baseline

    Assessment of Depression using Beck Depression Inventory

  62. Beck Depression Inventory

    Time frame: Evaluation A', 6- months

    Assessment of Depression using Beck Depression Inventory

  63. Beck Depression Inventory

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of Depression using Beck Depression Inventory

  64. Falls Efficacy Scale (FES-I)

    Time frame: Baseline

    Assessment of fear of falling using Falls Efficacy Scale

  65. Falls Efficacy Scale (FES-I)

    Time frame: Evaluation A', 6- months

    Evaluation of fear of falling using Falls Efficacy Scale

  66. Falls Efficacy Scale (FES-I)

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of fear of falling using Falls Efficacy Scale

  67. Activities-specific Balance Confidence (ABC) Scale

    Time frame: Baseline

    Assessment of Balance Confidence using ABC

  68. Activities-specific Balance Confidence (ABC) Scale

    Time frame: Evaluation A', 6- months

    Assessment of Balance Confidence using ABC

  69. Activities-specific Balance Confidence (ABC) Scale

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of Balance Confidence using ABC

  70. Minnesota Living with Heart Failure (MLHFQ)

    Time frame: Baseline

    Assessment of health-related quality of life using MLHFQ

  71. Minnesota Living with Heart Failure (MLHFQ)

    Time frame: Evaluation A', 6- months

    Assessment of health-related quality of life using MLHFQ

  72. Minnesota Living with Heart Failure (MLHFQ)

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of health-related quality of life using MLHFQ

  73. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline

    Assessment of Sleep Quality using PSQI

  74. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Evaluation A', 6- months

    Assessment of Sleep Quality using PSQI

  75. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of Sleep Quality using PSQI

  76. Intrinsic Motivation Inventory (IMI)

    Time frame: Baseline

    Assessment of Intrinsic Motivation using IMI

  77. Intrinsic Motivation Inventory (IMI)

    Time frame: Evaluation A', 6- months

    Assessment of Intrinsic Motivation using IMI

  78. Intrinsic Motivation Inventory (IMI)

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of Intrinsic Motivation using IMI

  79. Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)

    Time frame: Baseline

    Assessment of Depression and Anxiety using HRSD and HARS

  80. Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)

    Time frame: Evaluation A', 6- months

    Assessment of Depression and Anxiety using HRSD and HARS

  81. Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of Depression and Anxiety using HRSD and HARS

  82. Montreal Cognitive Assessment Test (MOCA)

    Time frame: Baseline

    Assessment of cognitive function using MOCA

  83. Montreal Cognitive Assessment Test (MOCA)

    Time frame: Evaluation A', 6- months

    Assessment of cognitive function using MOCA

  84. Montreal Cognitive Assessment Test (MOCA)

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of cognitive function using MOCA

  85. Falls

    Time frame: Baseline

    Assessment of the number of weekly falls

  86. Falls

    Time frame: Evaluation A', 6- months

    Assessment of the number of weekly falls

  87. Falls

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of the number of weekly falls

  88. Evaluation of Physical Activity and Sleep Quality using a wearable device

    Time frame: Baseline

    Evaluation of Physical Activity and Sleep Quality using a wearable device

  89. Evaluation of Physical Activity and Sleep Quality using a wearable device

    Time frame: Evaluation A', 6- months

    Evaluation of Physical Activity and Sleep Quality using a wearable device

  90. Evaluation of Physical Activity and Sleep Quality using a wearable device

    Time frame: Evaluation B', 3 months after evaluation A'

    Evaluation of Physical Activity and Sleep Quality using a wearable device

  91. Foot Preference Questionnaire (FPQ)

    Time frame: Baseline

    Assessment of Foot Preference during static balance or activities using FPQ

  92. Foot Preference Questionnaire (FPQ)

    Time frame: Evaluation A', 6- months

    Assessment of Foot Preference during static balance or activities using FPQ

  93. Foot Preference Questionnaire (FPQ)

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of Foot Preference during static balance or activities using FPQ

  94. Fear of Falling and Activity Restriction (SAFE)

    Time frame: Baseline

    Assessement of Fear of Falling and Activity Restriction (SAFE)

  95. Fear of Falling and Activity Restriction (SAFE)

    Time frame: Evaluation A', 6- months

    Assessment of Fear of Falling and Activity Restriction (SAFE)

  96. Fear of Falling and Activity Restriction (SAFE)

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of Fear of Falling and Activity Restriction (SAFE)

  97. Trail Making Test

    Time frame: Baseline

    Assessment of visual attention and task switching using Trail Making Test

  98. Trail Making Test

    Time frame: Evaluation A', 6- months

    Assessment of visual attention and task switching using Trail Making Test

  99. Trail Making Test

    Time frame: Evaluation B', 3 months after evaluation A'

    Assessment of visual attention and task switching using Trail Making Test

Study contacts

Contact information is provided by the study sponsor or research team.

Andriana Teloudi, PhDc

CONTACT

[email protected]

Evangelia Kouidi, Professor

CONTACT

[email protected]

+302310992189

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2023
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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