RecruitingNot ApplicableNCT06036615

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

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


Sponsor

Aristotle University Of Thessaloniki

Enrollment

100 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a structured exercise training program — and what happens when training stops (detraining) — affects frailty and fall risk in patients with chronic heart failure. The goal is to find safe and effective ways to keep heart failure patients stronger and more stable. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with heart failure (either reduced or preserved pump function) confirmed by echocardiogram - Your heart failure symptoms are mild to moderate (NYHA Class II or III) **You may NOT be eligible if...** - You have had a heart attack within the past 4 weeks - You have severe heart valve disease - You have dangerous heart rhythm problems - You have neurological or joint/mobility problems that prevent exercise - You have cognitive impairment - You are already in an organized exercise program - You are pregnant - Your heart failure is at its most severe stage (NYHA Class IV) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERExercise 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.


Locations(1)

Sports Medicine Laboratory, Aristotle University of Thessaloniki

Thessaloniki, Thermi, Greece

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06036615


Related Trials