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Aerobic and Strength Training With Caloric Restriction on 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 19, 2020
Sponsor:
Information provided by (Responsible Party):
Ghada Ebrahim El Refaye, Cairo University

Brief Summary:
A total of 42 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

Condition or disease Intervention/treatment Phase
Insulin Resistance Syndrome Other: Resistance exercise Other: Aerobic exercise Dietary Supplement: diet restriction Not Applicable

Detailed Description:
Forty two 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 plus diet restriction, 3 times per weeks for 8 weeks. Group (B): consisted of 20 women were participated in aerobic exercise plus diet restriction 3 times per weeks for 8 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Official Title: Impact of Concurrent Aerobic and Strength Training With Caloric Restriction on Insulin Resistance in Obese Premenopausal Women: A Randomized Controlled Trial
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
aerobic exercise
walking on treadmill
Other: Resistance exercise
Resistance exercise were performed for all participants in group (A) only 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 both groups (A,B) 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

Dietary Supplement: diet restriction
All participants in both groups (A,B) were instructed to follow a moderate restricted diet limited to (1800-2000) kcal/ day under supervision of a certified dietician. The diet contained: Protein and fibers: 20% carbohydrate: 50-60%, fat: low 20%.

resistive exercise
Resistance exercise were performed for all participants in group (A) included 9 exercise for big muscles of upper limbs
Other: Resistance exercise
Resistance exercise were performed for all participants in group (A) only 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 both groups (A,B) 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

Dietary Supplement: diet restriction
All participants in both groups (A,B) were instructed to follow a moderate restricted diet limited to (1800-2000) kcal/ day under supervision of a certified dietician. The diet contained: Protein and fibers: 20% carbohydrate: 50-60%, fat: low 20%.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716336


Locations
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Egypt
Faculty of physical therapy- Cairo University
Giza, Dokki, Egypt, 12613
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: ghada eb elrefaye, professor institutional review board of the Faculty of physical therapy, Cairo University
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Responsible Party: Ghada Ebrahim El Refaye, assistant professor of physical therapy for women's health, Cairo University
ClinicalTrials.gov Identifier: NCT03716336    
Other Study ID Numbers: CairoU90
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ghada Ebrahim El Refaye, Cairo University:
resistive exercises
aerobic exercises
diet
insulin resistance
premenopausal
Additional relevant MeSH terms:
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Insulin Resistance
Metabolic Syndrome
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases