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CWT Versus AT on Selected Cardiovascular Indices and Functional Capacity in Patients With Ischemic Cardiomyopathy.

Primary Purpose

Ischemic Cardiomyopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Circuit weight versus aerobic training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Cardiomyopathy

Eligibility Criteria

45 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Sixty male patients with ischemic cardiomyopathy as a result of a recent acute myocardial infarction event (≤2 months) with 40%<LVEF<50%. They are functionally classified as class II according to New York Heart Association (NYHA). Their age will be ranged from 45 to 55 years old. Their BMI will be ranged from 25 to 29.9 kg/m². They will have good mentality. Exclusion Criteria: Recurrent coronary heart disease. Severe valvular diseases. Underlying pulmonary disease (aspiration pneumonia, chronic obstructive pulmonary disease, pneumothorax, etc.). Inability to ambulate owing to physical problems (paresis induced by cerebral stroke, spinal cord injury, amputation, severe pain, dyspnea, etc.). muskloskletal problems (e.g. severe osteoarthritis or ankylosing spondylitis). Impaired cognitive function (vascular dementia, Alzheimer's dementia, other psychological disease, etc.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Circuit weight group

    Aerobic group

    Control Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Ejection fraction
    Will be measured by precentge

    Secondary Outcome Measures

    Blood pressure
    Will be measured by mmhg

    Full Information

    First Posted
    December 10, 2022
    Last Updated
    August 28, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05674955
    Brief Title
    CWT Versus AT on Selected Cardiovascular Indices and Functional Capacity in Patients With Ischemic Cardiomyopathy.
    Official Title
    Circuit Weight Versus Aerobic Training on Selected Cardiovascular Indices and Functional Capacity in Patients With Ischemic Cardiomyopathy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2023 (Anticipated)
    Primary Completion Date
    October 5, 2023 (Anticipated)
    Study Completion Date
    October 5, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To compare between the effect of circuit weight and aerobic training on selected cardiovascular indices and functional capacity in patients with ischemic cardiomyopathy.
    Detailed Description
    Ischemic cardiomyopathy (ICM) is a term that refers to the heart's decreased ability to pump blood properly due to myocardial damage brought upon by ischemia. Ischemic cardiomyopathy has a spectrum of clinical changes which eventually leads to congestive heart failure (CHF). Initially, there is a reversible loss of cardiac contractile function because of decreased oxygen supply to the heart muscle; however, when there is ischemia for a prolonged period, there is irreversible cardiac muscle damage resulting in cardiac remodeling. Remodeling is primarily achieved by myocardial fibrosis which results in decreased cardiac function, arrhythmia, and possible cardiac conduction system impairment. In ischemic cardiomyopathy, there is a significant impairment of the left ventricular systolic function, with a left ventricular ejection fraction (LVEF) less than 40% (Bhandari et al., 2021).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Cardiomyopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    3 groups of ischemic cardiomyopathy patients. 1st group receive circuit weight training. 2nd group receive aerobic. 3rd group receive medications
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Circuit weight group
    Arm Type
    Experimental
    Arm Title
    Aerobic group
    Arm Type
    Experimental
    Arm Title
    Control Group
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Circuit weight versus aerobic training
    Intervention Description
    Circuit weight :Duration: 30 min-60 min (total session) Frequency: 3 times / week. Intensity: increased load was established when subject was able to complete 12 repetitions ( Wayne, 2014) B- Aerobic training: This mode of exercise will be conducted for study group B as follows: Intensity: started by 60-85% of target heart rate according to each patient response Target heart rate (THR) = 60% -85% (maximum heart rate-resting heart rate) + resting heart rate Maximum heart rate (MHR) = (220-Age). Mode: Walking on treadmill. Duration: Each session consisted of 10 minutes warming up firstly then 30 minutes time of session ended by 10 minutes cool down exercises. Frequency: Three times / week (Nishi et al., 2011). C-Traditional medical treatment: This treatment will be conducted for all group A, B and C.
    Primary Outcome Measure Information:
    Title
    Ejection fraction
    Description
    Will be measured by precentge
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Blood pressure
    Description
    Will be measured by mmhg
    Time Frame
    2 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sixty male patients with ischemic cardiomyopathy as a result of a recent acute myocardial infarction event (≤2 months) with 40%<LVEF<50%. They are functionally classified as class II according to New York Heart Association (NYHA). Their age will be ranged from 45 to 55 years old. Their BMI will be ranged from 25 to 29.9 kg/m². They will have good mentality. Exclusion Criteria: Recurrent coronary heart disease. Severe valvular diseases. Underlying pulmonary disease (aspiration pneumonia, chronic obstructive pulmonary disease, pneumothorax, etc.). Inability to ambulate owing to physical problems (paresis induced by cerebral stroke, spinal cord injury, amputation, severe pain, dyspnea, etc.). muskloskletal problems (e.g. severe osteoarthritis or ankylosing spondylitis). Impaired cognitive function (vascular dementia, Alzheimer's dementia, other psychological disease, etc.)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21613745
    Citation
    Nishi I, Noguchi T, Iwanaga Y, Furuichi S, Aihara N, Takaki H, Goto Y. Effects of exercise training in patients with chronic heart failure and advanced left ventricular systolic dysfunction receiving beta-blockers. Circ J. 2011;75(7):1649-55. doi: 10.1253/circj.cj-10-0899. Epub 2011 May 25.
    Results Reference
    result

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    CWT Versus AT on Selected Cardiovascular Indices and Functional Capacity in Patients With Ischemic Cardiomyopathy.

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