NCT06036615 The Effect of Exercise Training and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure
| NCT ID | NCT06036615 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aristotle University Of Thessaloniki |
| Condition | Chronic Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-10-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Evangelia Kouidi, Professor
STUDY CHAIR
Director of Sports Medicine Laboratory, Aristotle University of Thessaloniki, Greece
Frequently Asked Questions
Who can join the NCT06036615 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Chronic Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06036615 currently recruiting?
Yes, NCT06036615 is actively recruiting participants. Contact the research team at kouidi@phed.auth.gr for enrollment information.
Where is the NCT06036615 trial being conducted?
This trial is being conducted at Thessaloniki, Greece.
Who is sponsoring the NCT06036615 clinical trial?
NCT06036615 is sponsored by Aristotle University Of Thessaloniki. The principal investigator is Evangelia Kouidi, Professor at Director of Sports Medicine Laboratory, Aristotle University of Thessaloniki, Greece. The trial plans to enroll 100 participants.
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