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

Effect of Upper Limb Ergometer on the Arthrogenic Index of Plasma in Post Menopausal Obese Women.

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.

Study Overview

• Status: Completed
• Conditions: Post Menopausal Obese Women
• Intervention / Treatment: Device: Electronic Upper limb( body) ergometer

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.

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

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12613
    • Outpatient clinic faculty of physical therapy at Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

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
No Intervention: control group; the participant will not do any exercise program but just they will take the routine medication.
Experimental: 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.	Device: Electronic Upper limb( body) ergometer; Electronic pedal for the upper limb using for training the upper body. Intensity, speed and resistance can be adjusted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the upper body ergometer on arthrogenic index ( triglyceride/ high density lipoprotein)	Effect of the upper body ergometer on arthrogenic index ( triglyceride/ high density lipoprotein)	after one month of the trial application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the upper body ergometer on total body weight kg.	Effect of the upper body ergometer on total body weight kg.	after one month of the trial application
Effect of the upper body ergometer on estimated maximum heart rate(beat/min).	Effect of the upper body ergometer on estimated maximum heart rate(beat/min).	after one month of the trial application

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Rana H El Banna, PHD, Faculty of physical therapy at Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 6, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Rana Hesham

Drug and device information, study documents

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