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

Not Applicable

Completed

• Conditions: Insulin Resistance Syndrome
• Interventions: Other: Resistance exercise; Other: Aerobic exercise; Dietary Supplement: diet restriction

• Registration Number: NCT03716336
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Study First Submitted: 2018-10-21
• Study First Submitted QC: 2018-10-21
• Study First Posted: 2018-10-23
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resistive exercise	Resistance exercise	Resistance exercise were performed for all participants in group (A) included 9 exercise for big muscles of upper limbs
aerobic exercise	Aerobic exercise	walking on treadmill
aerobic exercise	Resistance exercise	walking on treadmill
resistive exercise	Aerobic exercise	Resistance exercise were performed for all participants in group (A) included 9 exercise for big muscles of upper limbs
resistive exercise	diet restriction	Resistance exercise were performed for all participants in group (A) included 9 exercise for big muscles of upper limbs
aerobic exercise	diet restriction	walking on treadmill

Primary Outcome Measures

Name	Time	Method
HOMA test of insulin	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

Name	Time	Method
fasting blood glucose level	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 level	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

Trial Locations

Locations (1)

Faculty of physical therapy- Cairo University; 🇪🇬 Giza, Dokki, Egypt