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Aerobic and Strength Training With Caloric Restriction on Insulin Resistance in Obese Premenopausal Women

Primary Purpose

Insulin Resistance Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Resistance exercise
Aerobic exercise
diet restriction
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance Syndrome focused on measuring resistive exercises, aerobic exercises, diet, insulin resistance, premenopausal

Eligibility Criteria

35 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of physical therapy- Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

aerobic exercise

resistive exercise

Arm Description

walking on treadmill

Resistance exercise were performed for all participants in group (A) included 9 exercise for big muscles of upper limbs

Outcomes

Primary Outcome Measures

HOMA test of insulin
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

fasting blood insulin level
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
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

Full Information

First Posted
October 21, 2018
Last Updated
October 13, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03716336
Brief Title
Aerobic and Strength Training With Caloric Restriction on Insulin Resistance in Obese Premenopausal Women
Official Title
Impact of Concurrent Aerobic and Strength Training With Caloric Restriction on Insulin Resistance in Obese Premenopausal Women: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance Syndrome
Keywords
resistive exercises, aerobic exercises, diet, insulin resistance, premenopausal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Participants were assigned randomly used sealed envelope into two groups (A&B) equally in number.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercise
Arm Type
Other
Arm Description
walking on treadmill
Arm Title
resistive exercise
Arm Type
Other
Arm Description
Resistance exercise were performed for all participants in group (A) included 9 exercise for big muscles of upper limbs
Intervention Type
Other
Intervention Name(s)
Resistance exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Other Intervention Name(s)
exercise
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
diet restriction
Intervention Description
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 Measure Information:
Title
HOMA test of insulin
Description
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)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
fasting blood insulin level
Description
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
Time Frame
8 weeks
Title
fasting blood glucose level
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ghada eb elrefaye, professor
Organizational Affiliation
institutional review board of the Faculty of physical therapy, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy- Cairo University
City
Giza
State/Province
Dokki
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Aerobic and Strength Training With Caloric Restriction on Insulin Resistance in Obese Premenopausal Women

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