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
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring Caloric Restriction, Dietary Formulations, Exercise, Men
Eligibility Criteria
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
NCT ID
NCT03046641
First Posted
June 21, 2013
Last Updated
February 17, 2017
Sponsor
P.L.Shupik National Medical Academy of Post-Graduate Education
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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