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

NCT ID: NCT06036615

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: 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 B

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 3-month de-training period, continuing their normal physical activity.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Evangelia Kouidi

Professor of Sports Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evangelia Kouidi, Professor

Role: STUDY_CHAIR

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

Locations

Sports Medicine Laboratory, Aristotle University of Thessaloniki

Thessaloniki, Thermi, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Evangelia Kouidi, Professor

Role: CONTACT

kouidi@phed.auth.gr

+302310992189

Andriana Teloudi, PhDc

Role: CONTACT

teloudia@phed.auth.gr

Facility Contacts

Evangelia Kouidi, Professor

Role: primary

kouidi@phed.auth.gr

+302310992189

Other Identifiers

110/2022

Identifier Type: -

Identifier Source: org_study_id