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Exercise Duration Models, in Middle-aged Men

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous training
The interval training
Sponsored by
P.L.Shupik National Medical Academy of Post-Graduate Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring Caloric Restriction, Dietary Formulations, Exercise, Men

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Sedentary lifestyle
  • Good Health
  • Weight stability

Exclusion Criteria:

Abnormality or history of Disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    continuous training group

    interval training group

    Arm Description

    With the continuous training program

    With the interval training program

    Outcomes

    Primary Outcome Measures

    4-item
    weight, lipid profile (HDL, LDL, Cholesterol)

    Secondary Outcome Measures

    4-item
    weight, lipid profile (HDL, LDL, Cholesterol)

    Full Information

    First Posted
    June 21, 2013
    Last Updated
    February 17, 2017
    Sponsor
    P.L.Shupik National Medical Academy of Post-Graduate Education
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03046641
    Brief Title
    Exercise Duration Models, in Middle-aged Men
    Official Title
    The Study of Various Models of Exercise Duration on Weight Loss and Lipid Profile in Sedentary Overweight/Obese Middle-aged Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (Actual)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    February 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    P.L.Shupik National Medical Academy of Post-Graduate Education

    4. Oversight

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

    5. Study Description

    Brief Summary
    Duration of exercise is an important factor among the medical guides for weight loss. However, there is still little knowledge about other its models in middle-aged and older men. The present study aimed to determine the effects of the interval training on weight loss and lipid profile, and to compare its efficiency with the continuous training.
    Detailed Description
    Participants included sedentary men (age 45-75 years) with overweight or obesity (n= 82). They were randomly divided into two groups including continuous exercise, and interval exercise. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss
    Keywords
    Caloric Restriction, Dietary Formulations, Exercise, Men

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    continuous training group
    Arm Type
    Experimental
    Arm Description
    With the continuous training program
    Arm Title
    interval training group
    Arm Type
    Experimental
    Arm Description
    With the interval training program
    Intervention Type
    Other
    Intervention Name(s)
    Continuous training
    Other Intervention Name(s)
    group I
    Intervention Description
    Study group I (42 participants) received the continuous training.
    Intervention Type
    Other
    Intervention Name(s)
    The interval training
    Other Intervention Name(s)
    group II
    Intervention Description
    Study group II (40 participants) received the interval training.
    Primary Outcome Measure Information:
    Title
    4-item
    Description
    weight, lipid profile (HDL, LDL, Cholesterol)
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    4-item
    Description
    weight, lipid profile (HDL, LDL, Cholesterol)
    Time Frame
    3 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Sedentary lifestyle Good Health Weight stability Exclusion Criteria: Abnormality or history of Disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammadreza Rezaeipour, M.D., PhD.
    Organizational Affiliation
    Member of Scientific Board in Physical Education and Sport Sciences of Sistan and Baluchestan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Exercise Duration Models, in Middle-aged Men

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