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

NCT03716336 | Completed

• 1 other identifier: CairoU90
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Insulin Resistance Syndrome

Keywords

resistive exercises; aerobic exercises; diet; insulin resistance; premenopausal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• fasting blood insulin level

  8 weeks

• fasting blood glucose level

  8 weeks

Study Arms (2)

aerobic exercise

OTHER

walking on treadmill

Other: Resistance exercise; Other: Aerobic exercise; Dietary Supplement: diet restriction

resistive exercise

OTHER

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

Other: Resistance exercise; Other: Aerobic exercise; Dietary Supplement: diet restriction

Interventions

Resistance exercise OTHER

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

aerobic exercise; resistive exercise

Aerobic exercise OTHER

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.

Also known as: exercise

aerobic exercise; resistive exercise

diet restriction DIETARY_SUPPLEMENT

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%.

aerobic exercise; resistive exercise

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy- Cairo University

Giza, Dokki, 12613, Egypt

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Interventions

Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• ghada eb elrefaye, professor

  institutional review board of the Faculty of physical therapy, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants were assigned randomly used sealed envelope into two groups (A\&B) equally in number.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of physical therapy for women's health

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 23, 2018
• Study Start: November 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)