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

NCT ID: NCT03716336

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-05-01

Brief Summary

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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

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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.

Conditions

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Insulin Resistance Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Participants were assigned randomly used sealed envelope into two groups (A\&B) equally in number.

Study Groups

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aerobic exercise

walking on treadmill

Group Type OTHER

Resistance exercise

Intervention Type 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

Intervention Type 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.

diet restriction

Intervention Type 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%.

resistive exercise

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

Group Type OTHER

Resistance exercise

Intervention Type 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

Intervention Type 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.

diet restriction

Intervention Type 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%.

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

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%.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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exercise

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Ebrahim El Refaye

assistant professor of physical therapy for women's health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ghada eb elrefaye, professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Faculty of physical therapy- Cairo University

Giza, Dokki, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CairoU90

Identifier Type: -

Identifier Source: org_study_id

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