Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT06036615

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

Led by Aristotle University Of Thessaloniki · Updated on 2025-08-11

100

Participants Needed

1

Research Sites

115 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years of any gender
  • Confirmed heart failure diagnosis by echocardiography with reduced or preserved left ventricular ejection fraction
  • Symptomatic heart failure classified as New York Heart Association (NYHA) class II or III
Not Eligible

You will not qualify if you...

  • Acute myocardial infarction within the past 4 weeks
  • Severe valvular heart diseases
  • Potentially dangerous heart rhythm problems (malignant arrhythmias)
  • Neurological or orthopedic conditions preventing walking
  • Cognitive disorders
  • Poorly controlled other medical conditions
  • Currently participating in organized exercise programs
  • Pregnancy
  • NYHA class IV heart failure
  • Unable or unwilling to give informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sports Medicine Laboratory, Aristotle University of Thessaloniki

Thessaloniki, Thermi, Greece, 57001

Actively Recruiting

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Research Team

E

Evangelia Kouidi, Professor

CONTACT

A

Andriana Teloudi, PhDc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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