Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626542
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-02
Brief Title:
Effect of Intra-session Exercise Modes Sequence on Ventricular Function in Patients with Chronic Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EFFECT of INTRA-SESSION EXERCISE MODES SEQUENCE on VENTRICULAR FUNCTION in PATIENTS with CHRONIC HEART FAILUIRE
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to investigate the effect of intra-session exercise modes sequence on ventricular function in patients with chronic heart failure
Detailed Description:
Sixty male patients with chronic heart failure will be recruited in this study from National Heart Institute Giza Egypt Their ages will be ranged from 55 to 65 years old and they will be randomly divided into three groups as following
1 Study group A includes 20 patients who will receive intra-session exercise modes sequence of aerobic cardiovascular training CVT then resistance training RT exercises in addition to routine treatment programme
2 Study group B includes 20 patients who will receive intra-session exercise modes sequence of resistance training RT then aerobic cardiovascular training CVT exercises in addition to routine treatment programme
3 Control group C includes 20 patients who will receive routine treatment programme only
The exercise training programme for both study groups A and B will be applied once per day three times per week for 12 consecutive weeks
Inclusion criteria
All participated patients will be
Male patients with chronic heart failure and ages from 55 to 65 years old
Class II and class III heart failure according to NYHA classification
HFrEF category with LVEF 40 as documented by echocardiogram within 6 months
Receiving the same medical treatment programme for at least 3 months
Having a close level of functional capacity assessed by 6 minute walking test
Exclusion criteria
Patients who meet one of the following criteria will be excluded
Uncontrolled atrial fibrillation
Diabetes mellitus
Myocardial infarction or recurrent angina within 3 months
Patients with chronic chest diseases
Severe stenotic valvular disease
Clinically significant peripheral vascular disease
Exercise-induced angina ST segment changes or exercise induce AV block
Patients with chronic renal failure
Any cognitive impairment that interferes with prescribed exercise procedures
Musculoskeletal or neurological limitation to physical exercise
RESEARCH ETHICS
The protocol of this study will be approved by the ethics committee of scientific research at the Faculty of Physical Therapy Cairo University The study procedure will be explained in details for every patient before the initial assessment All patients will be informed about the purpose nature and potential risks of the study and a written informed consent will be obtained before participation in the study The participants right confidentiality will be observed strictly
1 Study group A includes 20 patients who will receive intra-session exercise modes sequence of aerobic cardiovascular training CVT then resistance training RT exercises in addition to routine treatment programme
2 Study group B includes 20 patients who will receive intra-session exercise modes sequence of resistance training RT then aerobic cardiovascular training CVT exercises in addition to routine treatment programme
3 Control group C includes 20 patients who will receive routine treatment programme only
The exercise training programme for both study groups A and B will be applied once per day three times per week for 12 consecutive weeks
Inclusion criteria
All participated patients will be
Male patients with chronic heart failure and ages from 55 to 65 years old
Class II and class III heart failure according to NYHA classification
HFrEF category with LVEF 40 as documented by echocardiogram within 6 months
Receiving the same medical treatment programme for at least 3 months
Having a close level of functional capacity assessed by 6 minute walking test
Exclusion criteria
Patients who meet one of the following criteria will be excluded
Uncontrolled atrial fibrillation
Diabetes mellitus
Myocardial infarction or recurrent angina within 3 months
Patients with chronic chest diseases
Severe stenotic valvular disease
Clinically significant peripheral vascular disease
Exercise-induced angina ST segment changes or exercise induce AV block
Patients with chronic renal failure
Any cognitive impairment that interferes with prescribed exercise procedures
Musculoskeletal or neurological limitation to physical exercise
RESEARCH ETHICS
The protocol of this study will be approved by the ethics committee of scientific research at the Faculty of Physical Therapy Cairo University The study procedure will be explained in details for every patient before the initial assessment All patients will be informed about the purpose nature and potential risks of the study and a written informed consent will be obtained before participation in the study The participants right confidentiality will be observed strictly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None