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Resistive and Aerobic Exercises in Insulin Resistance in Obese Premenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716336
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Ghada Ebrahim El Refaye, Cairo University

Tracking Information
First Submitted Date  ICMJE October 21, 2018
First Posted Date  ICMJE October 23, 2018
Last Update Posted Date October 23, 2018
Actual Study Start Date  ICMJE November 1, 2017
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2018)
HOMA test of insulin [ Time Frame: 8 weeks ]
A sample of 5ml of venous blood sample was drawn from the ante cubital vein after 10 hours fasting from all women in the two groups (A, B) for measurement of fasting blood glucose, fasting blood insulin and detection of insulin resistance (by HOMA-IR)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2018)
  • fasting blood insulin level [ Time Frame: 8 weeks ]
    A sample of 5ml of venous blood sample was drawn from the ante cubital vein after 10 hours fasting from all women in the two groups (A, B) for measurement of fasting blood insulin
  • fasting blood glucose level [ Time Frame: 8 weeks ]
    A sample of 5ml of venous blood sample was drawn from the ante cubital vein after 10 hours fasting from all women in the two groups (A, B) for measurement of fasting blood glucose
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resistive and Aerobic Exercises in Insulin Resistance in Obese Premenopausal Women
Official Title  ICMJE Resistive and Aerobic Exercises Versus Diet and Aerobic Exercise in Modulation of Insulin Resistance in Obese Premenopausal Women
Brief Summary A total of 40 premenopausal women diagnosed clinically as having insulin resistance. Their ages ranged from 35 to 45 years old; their body mass index was >30 kg/m2 and They were obese women complained of insulin resistance and non diabetic or cardiovascular disease, were randomly assigned to group A participated in aerobic & resistive exercise program, and group B participated in aerobic exercise and followed prescribed diet restriction program. Both of the groups (A&B) followed the treatment program 3 times per weeks for 8 weeks. Assessment of the fasting glucose, fasting insulin, and HOMA test of insulin resistance were measured for all subjects in both groups (A and B) was carried out before and after the end of the treatment program
Detailed Description Forty obese premenopausal women diagnosed as having insulin resistance were participated in this study. They were selected randomly from the out Patient Clinic of Obstetrics at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University. Their age ranged from 35 - 45years, their body mass (BMI) were>30kg/m2. Exclusion criteria of the study were as follows: Patients having diabetic or cardiovascular disease, Patients with life threatening disorders as renal failure and myocardial infarction, Patients with active malignancy and patients with severe hemorrhage, hyperthyroidism, acute viral diseases and mental disorders. Participants were assigned randomly used sealed envelope into two groups (A&B) equally in number. Group (A): (Combined resistive and aerobic exercise group) consisted of 20 women were participated in aerobic & resistive exercise program, 3 times per weeks for 8 weeks. Group (B): consisted of 20 women were participated in aerobic exercise 3 times per weeks for 8 weeks and followed prescribed diet restriction program.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
were randomly assigned to group A participated in aerobic and resistive exercise program, and group B participated in aerobic exercise and followed prescribed diet restriction program. Both of the groups (A&B) followed the treatment program 3 times per weeks for 8 weeks. Assessment of the fasting glucose, fasting insulin, and HOMA test of insulin resistance were measured for all subjects in both groups (A and B) was carried out before and after the end of the treatment program.
Masking: Single (Outcomes Assessor)
Masking Description:
Participants were assigned randomly used sealed envelope into two groups (A&B) equally in number.
Primary Purpose: Treatment
Condition  ICMJE Insulin Resistance Syndrome
Intervention  ICMJE
  • Other: Resistance exercise
    Resistance exercise were performed for all participants in group (A) included 9 exercise for big muscles of upper limbs (shoulder flexors muscles, shoulder extensors and shoulder abductors), lower limbs (hip flexors, hip extensors and knee flexors and knee extensors) and abdominal muscle using moderate work load (60 - 75% of IRM) 1set of 10 repetitions, progressing to 2 sets of 10 repetitions after four weeks for 20 minutes
  • Other: Aerobic exercise
    aerobic exercise were performed on treadmill. For 20 minutes. All patients in the (group A) had attended the program of a resistance exercises and followed by aerobic exercise for 8 weeks in form of 20 minutes walking on the treadmill without inclination.
    Other Name: exercise
Study Arms  ICMJE
  • aerobic exercise
    walking on treadmill
    Interventions:
    • Other: Resistance exercise
    • Other: Aerobic exercise
  • resistive exercise
    Resistance exercise were performed for all participants in group (A) included 9 exercise for big muscles of upper limbs
    Interventions:
    • Other: Resistance exercise
    • Other: Aerobic exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2018)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2018
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Their age ranged from 35 - 45years.
  • their body mass (BMI) were>30kg/m2.

Exclusion Criteria:

  • Patients having diabetic or cardiovascular disease.
  • Patients with life threatening disorders as renal failure and myocardial infarction
  • Patients with active malignancy.
  • patients with severe hemorrhage
  • hyperthyroidism.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03716336
Other Study ID Numbers  ICMJE CairoU90
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ghada Ebrahim El Refaye, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ghada eb elrefaye, professor institutional review board of the Faculty of physical therapy, Cairo University
PRS Account Cairo University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP