Effect of Upper Limb Ergometer on the AIP in Post Menopausal Obese Women.

NCT ID: NCT04676074

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-15
• Study Completion Date: 2021-03-31

Brief Summary

Participants had randomly divided into two equal groups. Group (A) which is the control group receive normal routine medication. Group (B) will receive normal routine medication with the treatment program of moderate intensity upper limb ergometer for 15 minute with frequency three times per week for four weeks.

Detailed Description

Control group (A):

1. Each participant will sign a consent form after receiving a detailed explanation about the procedure.

2. A blood sample will been taken by a nurse in a heparinized tube and delivered to lab within six hours.

3. BMI will been measured body weight(Kg) and height (m2)

a. BMI= body weight (Kg)/ height (m2).

4. Waist circumference will be measured.

5. After one month blood analysis evaluation will be done to record the response to the routine medication.

Training Procedure for group (B):

1. Each participant will sign a consent form after receiving a detailed explanation about the procedure.

2. A blood sample will been taken by a nurse in a heparinized tube and delivered to lab within six hours.

3. BMI will been measured body weight(Kg) and height (m2)

a. BMI= body weight (Kg)/ height (m2).

4. Waist circumference will be measured.

5. The maximum heart rate will be determined from Tanaka formula (208- 0.7 *age of the participant)

• Then the exercise load will be determined according heart rate reserve of the participants ( maximum heart rate - resting heart rate).

6. Start with sitting resting without any effort for 5 min then Start at a low speed and intensity for 5 minutes to warm up the body.

7. Increase the speed and intensity for 10-30 seconds before dropping it back for 2-5 minutes and Repeat according to the intensity.

8. Finally, a five minutes of cooling down with no resistance had performed.

9. After one month blood analysis evaluation will be done to record the response to the routine medication.

Conditions

Post Menopausal Obese Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

the participant will not do any exercise program but just they will take the routine medication.

Group Type: NO_INTERVENTION

No interventions assigned to this group

study group

will receive normal routine medication with the treatment program of moderate intensity upper limb ergometer for 15 minute with frequency three times per week for four weeks.

Group Type: EXPERIMENTAL

Electronic Upper limb( body) ergometer

Intervention Type: DEVICE

Electronic pedal for the upper limb using for training the upper body. Intensity, speed and resistance can be adjusted.

Interventions

Electronic Upper limb( body) ergometer

Electronic pedal for the upper limb using for training the upper body. Intensity, speed and resistance can be adjusted.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• female aged 45-60 years old.
• class 1 and 2 obesity.
• post menopausal.
• diagnosed as controlled diabetic.
• diagnosed as controlled hypertensive.

Exclusion Criteria

• uncontrolled diabetic.
• uncontrolled hypertensive.
• class 3 and morbid obesity.
• mentally unstable person.
• Any shoulder, hand and elbow orthopedic or neural disorders.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rana Elbanna

lecturer at faculty of physical therapy at Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rana H El Banna, PHD

Role: PRINCIPAL_INVESTIGATOR

Faculty of physical therapy at Cairo University

Locations

Outpatient clinic faculty of physical therapy at Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

Rana Hesham

Identifier Type: -

Identifier Source: org_study_id