Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06036615
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2023-09-07
Brief Title:
The Effect of Exercise Training and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Aristotle University Of Thessaloniki
Study Overview
Official Title:
The Effect of Exercise Training Intervention and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 BControl Group will continue their usual physical activity without participating in organized exercise programsAfter 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
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 BControl Group will continue their usual physical activity without participating in organized exercise programsAfter 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None