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

Impact of Concurrent Aerobic and Strength Training With Caloric Restriction on Insulin Resistance in Obese Premenopausal Women: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Insulin Resistance Syndrome
• Intervention / Treatment: Other: Resistance exercise; Other: Aerobic exercise; Dietary supplement: diet restriction

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt, 12613
      • Faculty of Physical Therapy- Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: 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%.
Other: 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 Names: 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks
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	8 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: ghada eb elrefaye, professor, institutional review board of the Faculty of physical therapy, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: October 21, 2018
• First Submitted That Met QC Criteria: October 21, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: insulin resistance; diet; premenopausal; aerobic exercises; resistive exercises
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: CairoU90

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No